Clinical Digest: Recent Clinical Trials on Birth Defects
To assist researchers and healthcare practitioners in staying up-to-date with the latest advancements in clinical research, the Clinical Digest Team has compiled a comprehensive list of recent clinical trials related to Birth Defects. These trials are organized by their release dates for your convenience. (Last updated on: 2025-05-02)
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TABLE 1: Clinical Digest: Recent Clinical Trials on Birth Defects
| Clinical Trial | Contact(s) | Date | |
|---|---|---|---|
| 1 | An Open-label, Dose Escalation, Phase I Study to Evaluate Safety and Tolerability of RX001 in Patients With KRAS Mutant Advanced Non-small Cell Lung Cancer PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-label, dose-escalation Phase I study to evaluate the safety and tolerability of RX001 monotherapy in patients with advanced KRAS mutant NSCLC. Subjects aged ≥19 years with advanced NSCLC with KRAS mutations will be enrolled. Based on the investigator’s judgment of the lung tumor location, RX001 will be administered as a single intratumoral treatment via bronchoscopy or CT-guided percutaneous injection. Additionally, after conducting safety, tolerability, and preliminary anti-tumor efficacy assessments for all subjects up to Week 12 (D84) following IP administration, … |
GENECRAFT | 2025-05-01 |
| 2 | A Multicenter, Open-Label Study to Assess The Pharmacokinetics And Safety of Bimekizumab in Pubertal Children And Adolescents With Moderate to Severe Hidradenitis Suppurativa PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the PK of bimekizumab following subcutaneous (sc) administration in study participants with moderate to severe hidradenitis suppurativa (HS) |
UCB BIOPHARMA SRL | 2025-04-30 |
| 3 | A Single-Arm, Multicenter, Open-Label Clinical Study to Evaluate The Efficacy and Safety of Axicabtagene Ciloleucel Injection As First-Line Therapy of High-Risk Large B-Cell Lymphoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this is Single-Arm, Multicenter, Open-Label Clinical Study is to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel Injection(Axi-cel) as First-Line Therapy of High-Risk Large B-Cell Lymphoma. |
ZHAO WEILI; | 2025-04-30 |
| 4 | A Phase II Multicenter, Open-label Study to Evaluate The Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Pediatric Patients With Duchenne Muscular Dystrophy (SHIELD DMD) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of satralizumab, a humanized anti-interleukin-6 receptor (aIL-6R) monoclonal antibody, in ambulatory and non-ambulatory participants with DMD age ≥ 8 to \< 18 years old receiving corticosteroid therapy. |
HOFFMANN LA ROCHE | 2025-04-04 |
| 5 | Post-marketing Observational Study of VYLOY (Zolbetuximab) Injection 100 Mg for Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in South Korea PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is for people in South Korea who have cancer in or around the stomach (gastric cancer) or cancer where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Their cancer is locally advanced, unresectable, or metastatic. Locally advanced means the cancer has spread to tissue close by. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. In South Korea, … |
ASTELLAS PHARMA KOREA | 2025-04-03 |
| 6 | CorEvitas Inflammatory Bowel Disease Pregnancy Registry (IBD-PR) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Data collected through the registry may be used to address a range of research questions and objectives, including but not limited to the following: Research question: Is there an increased risk of adverse maternal, fetal, or infant outcomes among individuals who are exposed to Inflammatory Bowel Disease (IBD) treatments during pregnancy? The primary objective of the registry is to estimate the prevalence of major congenital malformations among pregnant individuals with IBD who are exposed to an IBD pharmacotherapy during pregnancy. The secondary objectives of the registry are: To estimate the prevalence of other maternal, fetal, … |
RONNA L CHAN; | 2025-04-01 |
| 7 | GLP1-Receptor Agonists in Men With Prostate Cancer: Control of Cardiovascular Risk Factors and Prostate Biomarkers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: GAIN PC CONTROL is a study investigating Glucagon-Like Peptide-1 Receptor Agonists in men with prostate cancer who are being treated with androgen deprivation therapy. |
DARRYL LEONG; | 2025-04-01 |
| 8 | A Phase 3, Multicenter, Randomized, Open-label Study of Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have experienced disease progression following treatment with a platinum-based systemic therapy and an immune checkpoint inhibitor (ICI) compared with investigator’s choice of chemotherapy (ICC). |
DAIICHI SANKYO | 2025-03-27 |
| 9 | Comparative Study of Tolerance and Immunogenicity Induced By Primary Yellow Fever Vaccination in Pregnant and Non-pregnant Women PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to compare the immunogenicity induced by yellow fever vaccination administered during pregnancy with that induced by vaccination outside pregnancy, and to assess the maternal and fetal tolerance of this vaccination. |
KAOUTAR JIDAR; | 2025-03-24 |
| 10 | Phase 1 Clinical Trial of A Personalized Cancer Vaccine (PCV) Strategy in Patients with Solid Tumors and Molecular Residual Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a phase 1 clinical trial to evaluate the safety, feasibility and immunogenicity of a personalized cancer vaccine strategy in patients with solid tumors and molecular residual disease. The hypothesis of the trial is that synthetic long peptide personalized cancer vaccines will be safe and capable of generating measurable neoantigen-specific T-cell responses enabling ctDNA clearance. The personalized cancer vaccines are composed of synthetic long peptides corresponding to prioritized cancer neoantigens and will be co-administered with poly-ICLC. |
WILLIAM GILLANDERS; | 2025-03-20 |
| 11 | Open-Label, Single-Arm Trial to Evaluate The Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration. |
UCB BIOPHARMA SRL | 2025-03-11 |
| 12 | Pearls and Pitfalls in Usage of Plasma-Rich Platelet Graft Versus Dartos Flap in Distal Penile Hypospadias Repair PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Hypospadias is the most common congenital anomaly of penis. It is the second most common genital birth defect in boys after cryptorchidism The reinforcement of hypospadias repair with an intermediate layer is believed to reduce the incidence of postoperative complications such as uretherocautanous fistula. Hypospadias is classified by the location of the abnormal urethral meatus into distal penile (glandular ,subcoronal and distal penile), mid penile and proximal penile hypospadias Indeed, uretherocautanous fistula is most common complication after urethroplasty, … |
AHMED ALI AMEN DIAB; | 2025-03-01 |
| 13 | A Phase 3, Open-Label Study to Investigate The Long-Term Safety and Efficacy of LP352 in The Treatment of Seizures in Children and Adults With Developmental and Epileptic Encephalopathy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months. |
LONGBOARD PHARMACEUTICALS | 2025-02-12 |
| 14 | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this Phase 3 study is to demonstrate the efficacy of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP). |
DIANTHUS THERAPEUTICS | 2025-02-10 |
| 15 | A Randomized, Double-Blind, Placebo-Controlled (Participants Aged 18 to 60 Years) and Open-Label (Participants Aged 4 to 17 Years), Phase 2/3 Trial to Evaluate The Immunogenicity and Safety of 2 Doses of A Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Adults, Adolescents, and Children in Japan PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Dengue fever is caused by an infection with the dengue virus. Vaccination with TDV can help prevent dengue fever. The main purpose of this study is to learn about TDV’s ability to create an immune response in adults, adolescents, and children administered. In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first). During the study, participants will visit their study clinic 5 times. Participants will be in this study for approximately 270 days (9 months). |
TAKEDA | 2025-01-31 |
| 16 | A Phase 1, Open-Label Study to Determine The Biodistribution, Safety, and Tolerability of A Microdose of Radiolabeled BIIB080 Co-administered With BIIB080 in Healthy Adults Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, researchers will learn more about a study drug called BIIB080. BIIB080 is currently a drug under investigation for treatment of Alzheimer’s disease. The main question researchers are trying to answer in this study is how radiolabeled BIIB080 distributes in the brain and spinal cord. To help answer this question, … |
FATMA SEN; | 2025-01-30 |
| 17 | A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, … |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2025-01-22 |
| 18 | A Single Arm Phase 4 Trial to Evaluate The Safety and Efficacy of Oral Fruquintinib in The Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: High blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion. |
KHALEEL ASHRAF; | 2025-01-14 |
| 19 | A Phase 1b Open-label Study to Investigate Safety, Tolerability and Pharmacokinetics of Intravenous Blinatumomab in Japanese Adult Subjects With Newly Diagnosed Philadelphia-negative B-precursor Acute Lymphoblastic Leukemia (B-ALL) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main objective of the study is to evaluate safety and tolerability of blinatumomab in adult Japanese participants with newly diagnosed B-ALL. |
AMGEN | 2025-01-08 |
| 20 | A Retrospective, Observational Study Using A Healthcare Database to Assess The Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to An Unexposed Control Population PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of the study is to compare the occurrence of major congenital malformations (MCMs) among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are not exposed to any prescription insomnia drugs at any time during the pregnancy and to compare the occurrence of MCMs among live births between women with insomnia who are exposed to Dayvigo during the 1st trimester of pregnancy and women with insomnia who are exposed to a prescription insomnia drug other than Dayvigo during the 1st trimester of pregnancy. |
EISAI | 2025-01-03 |
| 21 | Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of this post-market study is to: * collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder * identify previously unknown side-effects |
LIFETECH SCIENTIFIC SHENZHEN | 2025-01-03 |
| 22 | An Open Label, Rollover Platform Study for Continued Study Treatment and Ongoing Safety Monitoring PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to collect long-term safety data in participants with cancers including acute myeloid leukemia, non-Hodgkin lymphoma, myelodysplastic syndrome, chronic lymphocytic leukemia (type of cancer of the blood and bone marrow in which the bone marrow makes a large number of abnormal blood cells) and advanced solid tumors and metastatic castration-resistant prostate cancer (mCRPC). |
JANSSEN RESEARCH & DEVELOPMENT | 2024-12-30 |
| 23 | An Open-label, Single-arm Study to Evaluate The Safety, Tolerability, Efficacy and Pharmacokinetics of Maribavir in Chinese Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Cidofovir or Foscarnet PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to learn how safe maribavir is in Chinese adults who have undergone hematopoietic stem cell or organ transplantation and have a cytomegalovirus (CMV) infection and how well they tolerate treatment with maribavir. Other aims are to see how effective maribavir is in treating CMV infection and getting rid of the symptoms, … |
XIAOYU ZHU; | 2024-12-16 |
| 24 | A Randomised, Double Blind, Placebo-controlled, Single Ascending Dose, Phase 1a/1b Multi-centre Study in Healthy Participants and Participants With Autosomal Dominant Polycystic Kidney Disease to Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK4771261 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a study where a new drug, called GSK4771261 is being tested. Neither the study doctors, study staff or participants will be aware of what treatment is being given. Part A is testing the new study treatment on healthy people. This is to see if it’s safe, what it does to the body, and how the body’s defense system responds to it. Part B is similar, but the study treatment will be given to people who have a kidney disease called autosomal dominant polycystic kidney disease (ADPKD). |
MICHALIS S KOSTAPANOS; | 2024-12-11 |
| 25 | AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months. |
PFIZER | 2024-12-08 |
| 26 | A Single-Center, Randomized, Investigator- and Participant-Blind, Placebo-Controlled, Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics After A Single Dose of Donzakimig in Healthy Chinese and Japanese Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic parameters of 2 dose strengths of donzakimig, each administered subcutaneously as a single dose, in healthy Chinese and Japanese study participants. |
UCB BIOPHARMA SRL | 2024-12-06 |
| 27 | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Trial to Evaluate The Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults. |
MERCK SHARP & DOHME | 2024-12-05 |
| 28 | A Phase 3b, Open Label, Randomized, Standard-of Care Control Arm, Multicenter, Superiority Study Evaluating The Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment. |
SHOBHA SWAMINATHAN; | 2024-12-02 |
| 29 | Spinal Cord Stimulation for Autonomic Recovery in Inpatient Rehabilitation After Acute SCI PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a randomized, single-blind, two-arm sham-controlled clinical trial to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal cord segments for cardiovascular function in adults (21-65 years old) with cervical and upper thoracic spinal cord injury (SCI) (≥T6) AIS A-D during inpatient rehabilitation and outpatient visits within three months after the onset. We will recruit 26 individuals with SCI, … |
SOSHI SAMEJIMA; | 2024-12-01 |
| 30 | An Open-Label Extension Study to Evaluate The Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants |
UCB BIOPHARMA SRL | 2024-11-19 |
| 31 | A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Study to Evaluate The Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: GSK4528287 is a drug being developed to treat like inflammatory bowel diseases like Crohns disease and ulcerative colitis. This study is the first time that GSK4528287 will be given to humans. The study will test single doses of GSK4528287 to check for side effects, measure blood levels, and understand how it works in the body. The study will start with a small dose, and the dose will be increased for each new group of participants. |
MARCIN BULA; | 2024-11-18 |
| 32 | A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate The Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people’s immune system can fight HPV infection and it goes away without treatment. For some people, … |
MERCK SHARP & DOHME | 2024-11-12 |
| 33 | Double-blind, Randomized, Placebo-controlled Study Evaluating The Safety and Efficacy of Nipocalimab in Reducing The Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT). |
JANSSEN RESEARCH & DEVELOPMENT | 2024-11-11 |
| 34 | A PHASE 1, FIRST IN HUMAN, RANDOMIZED, DOUBLE-BLIND, SPONSOROPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07832837 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07832837 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms |
PFIZER | 2024-11-05 |
| 35 | A Phase 3, Randomized, Modified Double-blind, 2-arm Study to Evaluate The Immunogenicity and Safety of High-Dose Inactivated Influenza Vaccine (IIV-HD) Compared With A Standard-dose Inactivated Influenza Vaccine (IIV-SD) in Participants 50 Through 64 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate Immunogenicity and Safety of a High-Dose (HD) Influenza Vaccine (IV) in Adults 50 through 64 Years of Age. |
SANOFI PASTEUR A SANOFI COMPANY | 2024-11-04 |
| 36 | A Phase 2/3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Part Study With Open-Label Extension (OLE) to Assess The Efficacy and Safety of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP. The study is looking at several research questions, including: * Safety of andecaliximab in participants with FOP * Whether andecaliximab reduces the number of new heterotopic bone lesions (Heterotopic Ossification; … |
ASHIBIO | 2024-10-25 |
| 37 | A Phase 3, Open-label, Uncontrolled Single-arm Study to Evaluate The Efficacy, Pharmacokinetics, and Safety of Avacopan in Combination With A Rituximab or A Cyclophosphamide-containing Regimen in Children From 6 Years to < 18 Years of Age With Active ANCA-associated Vasculitis (AAV) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV. |
AMGEN | 2024-10-22 |
| 38 | A Multicenter, Randomized, Double-Blind, Risankizumab-Controlled, Parallel-Group Study to Evaluate The Efficacy and Safety of Bimekizumab in Adult Study Participants With Active Psoriatic Arthritis PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to compare the efficacy of bimekizumab versus risankizumab after 16 weeks of treatment in study participants with active psoriatic arthritis (PsA). |
UCB BIOPHARMA SRL | 2024-10-21 |
| 39 | A Multicenter Open-Label, Uncontrolled Study to Evaluate The Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (ZLP) in pediatric study participants with generalized myasthenia gravis (gMG). |
UCB BIOPHARMA SRL | 2024-10-16 |
| 40 | A Phase 2b, Double-Blind, Multi-Center, Randomized, Comparator-Controlled Trial to Determine The Relative Efficacy, Safety, and Immunogenicity of The Investigational Oral SARS-CoV-2 Vaccine Tablet (VXA-CoV2-3.1) Against Currently Approved/Authorized MRNA COVID-19 Injectable Booster Vaccine in Adults Previously Immunized Against COVID-19 Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to determine the relative efficacy of the investigational oral severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine tablet VXA-CoV2-3.1 compared to a currently recommended vaccine for the prevention of symptomatic Coronavirus Disease 2019 (COVID-19). |
VAXART | 2024-10-08 |
| 41 | An Open-label Extension Study to Evaluate Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the Screening Visit of MG0006. |
UCB BIOPHARMA SRL | 2024-10-08 |
| 42 | A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate The Safety, Tolerability and Pharmacokinetics of GSK3915393 Administered As A Single Dose to Healthy Participants of Chinese, Japanese and European Ancestry, and to Assess The Effects of GSK3915393, on The Pharmacokinetics of Nintedanib PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: GSK3915393 is a new medicine which is being developed for a chronic lung disease called Idiopathic Pulmonary Fibrosis (IPF). This is a healthy participant study which has two parts. Part A will assess the safety, tolerability, and blood levels of GSK3915393 given as a single dose to healthy participants of Chinese, Japanese, and European ancestries. Part B is a drug-drug interaction (DDI) study that examines the effect of a single dose of GSK3915393 on the blood levels of a single dose of nintedanib, which is an approved drug for IPF. |
GLAXOSMITHKLINE | 2024-10-07 |
| 43 | Exposure to Endocrine Disruptors and Occurrence of Hypospadias: Toxicological, Environmental and Hormonal Imbalance Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to demonstrate the impact of Endocrine-Disrupting Chemicals (EDCs) on the risk of hypospadias incidence. It is a multicenter comparative case-control study, involving two groups. The first group consists of biological mothers who have given birth to children with hypospadias (Case Group), while the second group consists of biological mothers who have given birth to children without any malformations (Control Group). Through an integrative approach that combines a direct toxicological study of numerous pollutants present during pregnancy, and a comprehensive exposome assessment using validated tools, this study can significantly enhance our understanding and prevention of this malformation. |
NICOLAS KALFA; | 2024-10-03 |
| 44 | A Single-Centre, Open-Label, Single Sequence Study to Evaluate The Effect of Itraconazole on The Pharmacokinetics of Single Inhaled Doses of GSK3923868 in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate how itraconazole affects the blood concentration of GSK3923868 in healthy adults. |
GLAXOSMITHKLINE | 2024-09-30 |
| 45 | A Phase 1b Study Evaluating The Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 193 Alone or in Combination With Other Therapies in Subjects With Advanced Thoracic Tumors With Homozygous MTAP-deletion (Master Protocol) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The study aims to determine maximum tolerated dose (MTD) or recommended combination dose of the MTA-cooperative PRMT5 inhibitor AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-deleted thoracic tumors. The study also aims to determine the safety profile of AMG 193 administered in combination with other therapies in adult participants with metastatic or locally advanced MTAP-deleted thoracic tumors. |
AMGEN | 2024-09-17 |
| 46 | A Phase 3, Multicenter, Open-Label Study to Evaluate The Long-term Safety, Tolerability, and Efficacy of TAK-279 in Subjects With Moderate-to-Severe Plaque Psoriasis PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to check the side effects of TAK-279 and how well it is tolerated in participants with moderate-to-severe plaque psoriasis. All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules. Participants will be in the study for up to 217 weeks, including up to 35 days for the screening period, 52 weeks (Part A) up to 156 additional weeks (Part B) study treatment and 4 weeks follow up period. During the study, participants will visit their study clinic multiple times. |
JAMES KRELL; | 2024-09-04 |
| 47 | A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate The Safety and Efficacy of Brentuximab Vedotin Plus Doxorubicin, Vinblastine and Dacarbazine in Indian Patients With Untreated Stage 3/4 Classical Hodgkin Lymphoma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to check how safe brentuximab vedotin is in adults with untreated Hodgkin Lymphoma (HL) when given together with doxorubicin (Adriamycin), vinblastine and dacarbazine therapy (‘AVD’). Another aim is to learn how well treatment of brentuximab vedotin plus AVD works. All participants will receive brentuximab vedotin plus AVD for approximately 6 months. Participants will undergo tests like Echocardiography (ECHO) and pulmonary function testing (PFT) during the study. ECHO is a test that uses ultrasound to show how the heart muscle and valves are working; … |
AMARNATH POLISHETTY; | 2024-08-28 |
| 48 | An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Assess The Relative Bioavailability of Rocatinlimab (AMG 451) Autoinjector and Vial in Healthy Subjects PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants. |
AMGEN | 2024-08-06 |
| 49 | A First-in-Human, Randomized, Investigator-Blind, Participant-Blind, Placebo-Controlled Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB3101 in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the safety and tolerability of a single ascending dose of UCB3101 in cohorts of healthy male and female study participants. |
UCB BIOPHARMA SRL | 2024-07-31 |
| 50 | A Phase 3b Exploratory Multicenter Open-Label Study to Evaluate The Effect of Bimekizumab on Gene Expression Biomarkers in Study Participants With Moderate to Severe Plaque Psoriasis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effect of bimekizumab on gene expression biomarkers at Week 48 in a subset of study participants with moderate to severe plaque psoriasis (PSO) and moderate to severe plaque PSO with concomitant active psoriatic arthritis (PsA) who have provided skin biopsies for reverse transcription-polymerase chain reaction (RT-PCR). |
UCB BIOPHARMA SRL | 2024-07-29 |
| 51 | Paired Non-inferiority Study Comparing Overture Semi-automated Vitrification System (DaVitri) to Standard Manual Process for Clinical Pregnancy Outcomes PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will recruit 260 female recipients (and up to a maximum of 130 donors). This study is a sequel to the protocol CP-DV-000-GEN-003, entitled, NON-INFERIORITY STUDY COMPARING OVERTURE SEMI-AUTOMATED VITRIFICATION SYSTEM (DaVitri) TO STANDARD MANUAL PROCESS USING BLASTOCYST RATE AS THE PRIMARY END POINT. Donors will provide informed consent and will be enrolled before egg retrieval. Once the oocytes are retrieved, they will undergo thorough denudation to remove corona cells and will be assessed for maturity. Subsequently, mature MII oocytes exhibiting good morphology, as per the Vienna Consensus, ranging between 12 and 30 in number, … |
OVERTURE LIFE | 2024-07-18 |
| 52 | Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS P.G12C Mutation (CodeBreaK 301) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to compare progression free survival (PFS) in treatment-naïve Participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb. |
AMGEN | 2024-07-17 |
| 53 | A Multicenter, Open-Label, Outpatient Study to Evaluate The Safe And Effective Use of A Zilucoplan Auto-Injector Combination Product for Subcutaneous Self-Administration By Study Participants With Generalized Myasthenia Gravis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effectiveness, safety and tolerability of zilucoplan auto-injector (ZLP-AI) self-administration. |
UCB BIOPHARMA SRL | 2024-07-15 |
| 54 | A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE LONG-TERM SAFETY AND TOLERABILITY OF BRIVARACETAM IN STUDY PARTICIPANTS WITH CHILDHOOD ABSENCE EPILEPSY OR JUVENILE ABSENCE EPILEPSY PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy. |
UCB BIOPHARMA SRL | 2024-07-10 |
| 55 | Dose-finding for Dobutamine During Transitional Circulation in The Very Preterm Infant PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Single centre, dose finding trial to establish the minimum effective dose of dobutamine required to treat hemodynamic insufficiency, defined as low superior vena cava (SVC) flow, in infants below 33 weeks’ gestation during transitional circulation (first 72 hours from birth). |
INSTITUTO DE INVESTIGACIÓN HOSPITAL UNIVERSITARIO LA PAZ | 2024-06-24 |
| 56 | A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants With Relapsed/Refractory Multiple Myeloma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to compare the pharmacokinetics (processes by which drugs are absorbed, distributed in the body, and excreted) between teclistamab made from the current commercial manufacturing process (pre-change) and the new manufacturing process (post-change). |
JANSSEN RESEARCH & DEVELOPMENT | 2024-06-07 |
| 57 | Long-Term Extension Study (AtDvance) to Evaluate The Safety and Efficacy of GSK1070806 in Participants With Moderate to Severe Atopic Dermatitis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799). |
LINDSAY SKYE ACKERMAN; | 2024-06-05 |
| 58 | A Randomized, Double-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics, and The Impact of Food on Pharmacokinetics of HS-10398 in Healthy Participants, and A Clinical Trial to Assess The Pharmacokinetic Characteristics of HS-10398 in Participants With Kidney Dysfunction PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A randomized, double-blind, placebo-controlled, dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and the impact of food on pharmacokinetics of oral HS-10398 in Chinese healthy participants, and a clinical trial to assess the pharmacokinetic characteristics of oral HS-10398 in Chinese participants with kidney dysfunction |
JIANGSU HANSOH PHARMACEUTICAL | 2024-05-31 |
| 59 | A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate The Immunogenicity and Safety of MRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA). |
GLAXOSMITHKLINE | 2024-05-23 |
| 60 | A Phase 3b, Open-label Study to Evaluate The Non-inferiority of The Immune Response and to Evaluate The Safety of The RSVPreF3 OA Investigational Vaccine in Adults 18-49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults >=60 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (\>=) 60 YOA and above |
GLAXOSMITHKLINE | 2024-04-29 |
| 61 | Efficacy and Safety of The Ton-bridge Carotid Stent for The Treatment of Carotid Artery Stenosis: A Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis. |
LIQUN JIAO; | 2024-04-24 |
| 62 | A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma. |
DAIICHI SANKYO | 2024-04-10 |
| 63 | A Phase I/II Trial of Neoadjuvant ADI-PEG 20 in Combination With Ifosfamide and Radiotherapy in Soft Tissue Sarcoma (STS) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. |
MIA WEISS; | 2024-03-14 |
| 64 | A Randomized, Double-blind, Placebo-controlled Phase Ⅰb/Ⅱ Study to Investigate The Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10506 in Chinese Adult Participants With Insomnia Disorder PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder. |
JIANGSU HANSOH PHARMACEUTICAL | 2024-03-01 |
| 65 | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate The Safety and Efficacy of Fazirsiran in The Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F1 Fibrosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver cells, which leads to liver problems such as liver scarring (fibrosis), continuing liver damage (cirrhosis), … |
JUSTIN REYNOLDS; | 2024-03-01 |
| 66 | AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that: * is hard to treat (advanced) and may have spread to other organs (metastatic). * is sensitive to hormonal therapy (it is called estrogen receptor positive). * is no longer responding to treatments taken before starting this study. All the participants will receive vepdegestrant and PF-07220060. Both medicines will be taken by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicines are safe and effective. Participants will continue to take vepdegestrant and PF-07220060 until: * their cancer is no longer responding, or * side effects become too severe. They will have visits at the study clinic about every 4 weeks. |
PFIZER | 2024-02-19 |
| 67 | A Phase 1 Open-label, Randomized, Parallel-group Study to Assess The Relative Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Subjects PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants. |
AMGEN | 2024-02-15 |
| 68 | A Phase 3, Multicenter, Open-label Study to Evaluate The Efficacy and Safety of JNJ-77242113 for The Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate how effective JNJ-77242113 is in participants with generalized pustular psoriasis (GPP) or erythrodermic psoriasis (EP). |
JANSSEN PHARMACEUTICAL K K | 2024-02-09 |
| 69 | An Open-label, Non-randomized, Prospective Trial to Evaluate The Effect of Renal Function Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics in Patients With AML or MDS Undergoing Allogeneic Hematopoietic Stem Cell Transplantation PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aim is to assess, if treosulfan pharmacokinetics are influenced by declined renal function and by race/ethnicity of patients. The study also aims to determine an appropriate safe dose of treosulfan, when patient’s renal function is impaired. The participants of this study are undergoing allogenic hematopoietic stem cell transplantation for treatment of acute myeloid leukemia or myelodysplastic syndrome. |
MEDAC | 2024-02-01 |
| 70 | A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of HS-10511 in Healthy Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single oral dose and multiple oral doses in healthy adult subjects. |
JIANGSU HANSOH PHARMACEUTICAL | 2024-01-31 |
| 71 | A Phase 3, Double-Blind Study to Evaluate The Long-Term Safety and Efficacy of Povorcitinib in Participants With Moderate to Severe Hidradenitis Suppurativa PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate long-term safety and efficacy of povorcitinib in participants with moderate to severe hidradenitis suppurativa who completed the 54 weeks of study treatment within the originating parent Phase 3 studies (INCB 54707-301 \[NCT05620823\] or INCB 54707-302 \[NCT05620836\]). |
INCYTE | 2024-01-30 |
| 72 | A Phase 3, Randomized, Double-Blind Study to Evaluate The Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD). |
MERCK SHARP & DOHME | 2024-01-18 |
| 73 | A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema PF:2 Related Papers Related Patents Related Grants Related Experts View Abstract: This is a multicenter, open-label, dose ranging study with 3 cohorts in the dose-escalation portion of the study and 1 cohort in the combination therapy portion of the study. An … |
SHAILESH GUPTA; | 2024-01-13 |
| 74 | A Single-dose, Open-label, Randomized, 2-way, Cross-over Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer From Viatris to Neolpharma, for Spironolactone/Hydrochlorothiazide Film Coated Tablets in Healthy Adult Participants Under Fasted Conditions PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to understand how the body processes Spironolactone and Hydrochlorothiazide after taking Spironolactone and Hydrochlorothiazide film coated tablets manufactured at two sites: Viatris and Neolpharma by mouth. The study is seeking for: * Both male and female participants. * participants who must be 18 to 75 years of age. * Body Mass Index of participants should be 16 to 32 kilogram per meter squared and body weight should be more than 50 kilograms (110 pounds). About 40 participants will enter the study (20 in each group). Study consists of two periods. On Day 1 of each period, participants will receive a single amount of Spironolactone and Hydrochlorothiazide tablets. The total duration of study will be 71 days. Follow up may occur via telephone after 35 days after taking the final tablet of the study medicine. |
PFIZER | 2023-12-26 |
| 75 | A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate The Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter \[mL\]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India. |
GLAXOSMITHKLINE | 2023-12-14 |
| 76 | A Two-part Phase 1 Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3862995B Following Single Ascending Doses in Healthy Participants and Repeat Doses in Participants With Chronic Obstructive Pulmonary Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD). |
MICHAEL DENENBERG; | 2023-11-27 |
| 77 | A Multicenter Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate The Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC) (including at least levodopa therapy) over placebo with regard to motor fluctuations time spent in the OFF state (OFF time) in study participants with advanced Parkinson’s Disease (PD). |
UCB BIOPHARMA SRL | 2023-11-17 |
| 78 | A PHASE 1, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY FOLLOWING SINGLE AND MULTIPLE DOSES OF SISUNATOVIR IN CHINESE HEALTHY PARTICIPANTS PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to learn about: * The activity of sisunotavir in the body over a period. It includes the processes by which sisunotavir is absorbed, distributed in the body, localized in the tissues, … |
PFIZER | 2023-11-03 |
| 79 | Use-result Surveillance for PADCEV Injection 20 Mg and 30 Mg (Enfortumab Vedotin) in South Korea PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer. People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, … |
ASTELLAS PHARMA KOREA | 2023-11-01 |
| 80 | Does Small Scale Cereal-based Fortification Hold The Key to Improved Micronutrient Status in Ethiopia? The Case of Folic Acid and Vitamin B12 in Teenage Girls in Arba Minch, Ethiopia PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Folic acid and vitamin B12 play an interdependent role in key cellular processes, namely deoxyribonucleic acid synthesis, cell division, red blood cell formation, and nervous system myelination. A deficiency of either vitamin will predispose teenagers to many diseases, which persist across their lifespan. Fortification of food with micronutrients has been promoted to reduce micronutrient deficiencies. A large segment of vulnerable populations in low- and middle-income countries (LMICs) resides in rural settings and has limited access to large-scale commercialized fortified foods. In such operational constraints, … |
STEFAAN DE HENAUW; | 2023-11-01 |
| 81 | A Prospective, Observational Study to Assess The Real-World Usage and Outcomes of HyQvia in Patients With Multiple Myeloma (MM) Diagnosed With Secondary Immunodeficiency (SID) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, multiple myeloma participants with secondary immunodeficiency (SID) will be treated with HyQvia according to their clinic’s standard practice. The study’s main aim is to look into infusion parameters of HyQvia administration. |
ALEXANDRA JUNGOVA; | 2023-10-17 |
| 82 | A Phase 2b Multicenter, Randomized, Placebo- Controlled, Dose-Ranging Study to Evaluate The Efficacy and Safety of JNJ-77242113 for The Treatment of Moderately to Severely Active Ulcerative Colitis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis. |
JANSSEN RESEARCH & DEVELOPMENT | 2023-10-09 |
| 83 | Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess The Risk of Pregnancy and Maternal Complications and Adverse Effects on The Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy And/or Lactation PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicable, … |
IPSEN | 2023-09-28 |
| 84 | A Non-interventional, Multicentre Retrospective Study of The Effectiveness and Safety of Teduglutide (REVESTIVE®) in Short Bowel Syndrome Patients in Canada PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada. This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study. The study will be conducted using data from the Takeda OnePath Patient Support Program (PSP) or Takeda Global Pharmacovigilance. |
CHRIS PETTENGELL; | 2023-09-23 |
| 85 | A Multicenter Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Adult Participants With Chronic Diabetic Peripheral Neuropathic Pain (DPNP) /NEPTUNE-17 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a multicenter randomized, double-blind, placebo-controlled phase 2 study to evaluate efficacy, safety, tolerability, pharmacokinetics, and target engagement of GSK3858279 in adult participants with chronic Diabetic Peripheral Neuropathic Pain (DPNP). The primary objective of the study is to assess the efficacy of GSK3858279 in participants with DPNP who have been unable to sufficiently manage their pain. |
GLAXOSMITHKLINE | 2023-09-20 |
| 86 | A Phase 1, Double-Blind, Single Ascending Dose Study to Evaluate The Safety, Pharmacokinetics, and Pharmacodynamics of TRL345 in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study in healthy volunteers will provide a basis for evaluation of TRL345 as a first in human study, specifically, important safety, tolerability, and pharmacokinetic data, and provide serum samples for ex vivo studies of concentration-dependent antiviral activity to support the dose selection for as well as design and conduct of a clinical study in transplant patients. |
TRELLIS BIOSCIENCE | 2023-09-14 |
| 87 | A Multicentre Randomized, Double-blind, Placebo Controlled, Dose-finding, Phase 2 Study (MARS-17) of GSK3858279 in Adult Participants With Moderate to Severe Pain Due to Knee Osteoarthritis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279. |
GLAXOSMITHKLINE | 2023-09-13 |
| 88 | Clinical Evaluation of Intracardiac Ultrasound With The NUVISION NAV Ultrasound Catheter PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the performance and safety of using the investigational catheter. |
BIOSENSE WEBSTER | 2023-09-05 |
| 89 | Extending Omalizumab Treatment Intervals in Patients With Chronic Spontaneous Urticaria (EXOTIC Trial): A Multicentre, Randomized, Open-label, Non-inferiority Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a multicentre, randomized, open-label, non-inferiority clinical trial. The purpose and aim of this study is to investigate if patients with well controlled (UCT score score ≥ 12) chronic spontaneous urticaria (CSU) on omalizumab 300 mg every four weeks can extend treatment intervals and maintain disease control. |
SIMON FRANCIS THOMSEN; | 2023-09-01 |
| 90 | A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating The Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution, Used Two Times Daily in Healthy Adult Subjects and in Pediatric Subjects With A History or Family History of Atopic Disease (Including Allergic Conjunctivitis) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects. |
BAUSCH & LOMB | 2023-08-17 |
| 91 | A Phase 1, Dose Escalation, Double Blind, Placebo Controlled Clinical Trial With Controlled Human Malaria Infections (CHMI) to Evaluate Safety, Tolerability, Pharmacokinetics, and Protective Efficacy of An Anti-Malaria Human Monoclonal Antibody, MAM01, in Healthy, Malaria-Naive Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a First-in-Human (FiH), randomized, two-part, dose-escalation trial of MAM01 monoclonal antibody (mAb) targeting the Plasmodium falciparum (Pf) Circumsporozoite Protein (CSP). This study will evaluate the safety, tolerability, pharmacokinetics (PK), and protective efficacy of MAM01, as well as safety and PK of repeat subcutaneous (SC) dosing. Part A will have a double-blind, placebo-controlled design. Part B will randomize participants to one of three open-label MAM01 dose groups; a separate non-randomized group will be enrolled to include participants who will receive no treatment and act as infectivity controls. |
BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE | 2023-08-14 |
| 92 | A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody), Cemiplimab (Anti-PD-1 Antibody), and Chemotherapy Versus Cemiplimab and Chemotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Irrespective of PD-L1 Expression Levels PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is researching an investigational drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and chemotherapy, individually called a study drug or collectively called study drugs. ‘Investigational’ means that the study drug is not approved for use outside of this study by any Health Authority. Examples of chemotherapy drugs include the following: Paclitaxel plus carboplatin, and Pemetrexed plus cisplatin. The study is being conducted in patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is for treating advanced NSCLC, … |
REGENERON PHARMACEUTICALS | 2023-08-08 |
| 93 | A Phase 3, Open-Label Extension Study to Evaluate The Long-Term Safety and Efficacy of Fazirsiran in Participants With Alpha-1 Antitrypsin Deficiency-Associated Liver Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to learn if fazirsiran is safe during long-term use in people with liver disease caused by the abnormal Z-alpha-1 antitrypsin (Z-AAT) protein. People who have taken part in previous fazirsiran studies (AROAAT2001 \[NCT03945292\] or AROAAT2002 \[NCT03946449\]) can continue to receive fazirsiran every 3 months as long as they participate in this study, … |
TAKEDA | 2023-08-08 |
| 94 | A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate The Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to As Q-Pan H5N8), Given As A Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (\>=)18 years of age. |
GLAXOSMITHKLINE | 2023-08-03 |
| 95 | A Phase Ib Clinical Study to Evaluate The Efficacy and Safety of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules As First-line Treatment for Advanced Hepatocellular Carcinoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQB2618 injection combined with penpulimab injection and Anlotinib Hydrochloride Capsules in patients with advanced HCC. |
CHIA TAI TIANQING PHARMACEUTICAL GROUP | 2023-08-01 |
| 96 | A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate The Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged \>=50 years of age. |
GLAXOSMITHKLINE | 2023-07-28 |
| 97 | CIBINQO™ Pregnancy Registry: An Observational Study of The Safety of Abrocitinib Exposure in Pregnant Women and Their Offspring PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this observational study is to learn about the safety of abrocitinib (CIBINQO) in pregnant women and the offspring. The study is seeking participants who: * Are currently or recently pregnant * Receive at least one dose of CIBINQO at any time during pregnancy or prior to pregnancy OR have a diagnosis of moderate-to-severe atopic dermatitis All participants in this study will receive treatment according to routine care, … |
PFIZER | 2023-07-25 |
| 98 | Combining A CD40L-Binding Protein (VIB4920) With A TNF-alpha Inhibitor for The Treatment of Inadequately Controlled Rheumatoid Arthritis (ITN092AI) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective is to determine if the addition of a 12-week course of treatment with VIB4920 to TNFi treatment will result in improved clinical disease control in patients with RA who have had an inadequate response to a TNFi. |
JONATHAN GRAF; | 2023-07-25 |
| 99 | A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate The Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study. In Part 1, one set of participants will take either BIIB091 or diroximel fumarate (DRF). In Part 2, … |
SURAJ A. MULEY; | 2023-07-25 |
| 100 | Effect of Saleem’s Protocol on Foot Deformity in Congenital Talipes Equinovarus PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main objective of this study is to evaluate the effectiveness of Saleem’s protocol treatment plan for congenital ideopathic talipes equino varus deformity using early tenotomy and serial foot casting. The combined effect of early tenotomies and foot serial casting has not been proven in prior investigations. Ten kids were involved in this pilot study where Saleem’s protocol approach was used. With the use of the PIRANI score, the baseline reading was evaluated. Readings were obtained before each cast performance. This study results show’s early correction of foot deformity with average 4 to 5 cast and no recurrence. |
NAYAB IQBAL; | 2023-07-24 |
| 101 | HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting A Baby With Congenital Heart Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. In partnership with diverse parent and clinician stakeholders, our team designed HEARTPrep, an innovative, … |
ERICA SOOD; | 2023-07-14 |
| 102 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Effect of Bi-26 (Strain of Bifidobacterium Longum, B. Infantis) Supplementation Versus Placebo on Weight Gain in Underweight Infants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The burden of disease experienced by underweight children is significant, particularly in low- and middle-income countries. Gut dysbiosis, an imbalance in microbial composition, is thought to play a role in nutrient malabsorption leading to underweight infants and failure to thrive. Bifidobacterium longum subspecies infantis (B. infantis) is a commensal bacterial strain important in the breakdown of human milk oligosaccharides (HMOs). A decrease in abundance or absence of B. infantis could lead to inadequate HMO processing, … |
BILL & MELINDA GATES MEDICAL RESEARCH INSTITUTE | 2023-07-03 |
| 103 | A Randomized, Double-Blind Phase 2/3 Study of Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50% PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab (also called REGN2810), individually called a study drug or collectively called study drugs. The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aim of the study is to see how effective the combination of fianlimab and cemiplimab is in treating advanced NSCLC, in comparison with cemiplimab by itself. The study is looking at several other research questions, … |
REGENERON PHARMACEUTICALS | 2023-06-30 |
| 104 | The Effect of Vitamin C for Iron Supplementation During Pregnancy With Risk of Anemia PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Anemia is a common problem during pregnancy. Most studies have demonstrated that anemia during pregnancy have adverse effects on their pregnancy outcome, which is important and should pay attention to prevent and solve such problems. The most common cause of anemia is iron deficiency. Several studies reveal that Vitamin C promotes iron absorption. In this study we will compare between Vitamin C with iron supplement and iron supplement alone in prevention of anemia in pregnancy. |
RAJAVITHI HOSPITAL | 2023-06-28 |
| 105 | An Observational Study Utilising Data From EU National MS Registries to Estimate The Incidence of Anti-Natalizumab Antibody Among Patients Who Receive Subcutaneous Administration of Natalizumab for Treatment of RRMS PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous (IV) to natalizumab SC (natalizumab-experienced cohort); to evaluate serious adverse events (SAEs), including injection reactions and hypersensitivity reactions, by ANA status and to assess the proportion of participants who had MS relapse, by ANA status. |
BIOGEN | 2023-06-23 |
| 106 | A PHASE 1, OPEN-LABEL, AGE-DESCENDING, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (RSVpreF) IN CHILDREN 2 TO <18 YEARS OF AGE PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn about the safety and immune activity of the vaccine (called RSVpreF) in children 2 to \<18 years of age. This study will identify the dose level to be used in Phase 2/3 trials in this age cohort. All participants will receive one injection of RSVpreF. This study has four study visits, two in-clinic and two telehealth visits. Blood samples will be collected for testing. This study is about 6 months long for each participant and will be conducted in the United States. |
PFIZER | 2023-06-22 |
| 107 | Pilot Evaluation of Potential Environmental Causes of Uveal Coloboma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Uveal coloboma is a congenital eye malformation. It is thought to be a genetic condition. But it might have environmental causes as well. Researchers want to study the mothers of children with coloboma. They will use parts of the National Birth Defects Prevention Study (NBDPS) Mother Questionnaire. NBDPS was a large study of birth defects. It collected data from 1997 to 2011. Researchers will use NBDPS and NIH data as well as the new survey to produce data that can serve as a basis for further study. Objective: To explore maternal factors and exposures during the first trimester of pregnancy as potential causes of uveal coloboma and to correlate exposure data to clinical data from affected children. Eligibility: Mothers of probands with coloboma who have taken part in NIH study 06-EI-0230, 04-EI-0039, or 13-EI-0049. Design: This is a hybrid study. It will use existing data from NBDPS and NIH studies. It will also use NBDPS for a new survey of mothers of children with coloboma. Participants will take the survey by phone. Their pregnancy records may be reviewed. They will be asked about: Important dates Health and medicines Tobacco, alcohol, and substance use Parents occupations Family demographics. The survey will take 1 hour or less to complete. Some data were obtained in past NIH studies. These data are largely from children. Some family data may be used as well. For example, eye exam data, gene test results, and family history of coloboma may be used. If a participant did not consent to the future use of their data, then their data will not be used. Data will be stored in a secure NIH database. … |
BRIAN P BROOKS; | 2023-06-20 |
| 108 | A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07923568 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn how the study medicine (PF-07923568) is processed in participants with liver function loss compared to healthy participants. The different levels of liver function loss can be mild, moderate or severe. This study is seeking participants who: * are male or female of 18 years of age or older. * are examined to be healthy (group with no loss of liver function). * have mild, moderate, … |
PFIZER | 2023-06-07 |
| 109 | An Observational Database Study to Monitor Safety-related Endpoints After Marketing of Cecolin® PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: This study was a retrospective-prospective real-world study to assess the safety among females receiving the 2vHPV vaccine (CecolinⓇ). |
XIAMEN INNOVAX BIOTECH | 2023-06-06 |
| 110 | Phase IV, 12-week, Single Arm, Open Label Study Evaluating The Safety and Efficacy of Fixed Dose Triple Combination FF/UMEC/VI Administered Once Daily in The Morning Via A Dry Powder Inhaler in Participants With Chronic Obstructive Pulmonary Disease in India PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate safety and efficacy of FF/UMEC/VI via ELLIPTA® inhaler. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies. |
GLAXOSMITHKLINE | 2023-06-06 |
| 111 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of Rimegepant for Migraine Prevention in Chinese Participants PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to learn about the effects of Rimegepant to help prevent migraine. This study is seeking for participants who: * Are male and female of 18 years of age or older. * Have at least 1 year history of migraine . * Did not take any medication for migraine before the start of this study. The study will go on for around 30 weeks, including 4 Phases and 11 Visits. Participants who are selected for the study will be randomly assigned to treatment groups. After which, … |
PFIZER | 2023-05-15 |
| 112 | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Evaluate The Efficacy and Safety of DC-806 in Participants With Moderate to Severe Plaque Psoriasis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This was a 12-week treatment, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the efficacy and safety of DC-806 in participants with moderate to severe plaque psoriasis. This study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of DC-806 in participants with moderate to severe plaque psoriasis. |
DICE THERAPEUTICS INC A WHOLLY OWNED SUBSIDIARY OF ELI LILLY | 2023-05-02 |
| 113 | The Role of The Gut Microbiome in Post-smoking Weight Gain PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Investigating the effect of smoking and smoking cessation on the intestinal microbial composition and function. The investigators wish to determine whether the alteration in gut microbiome drives the significant weight gain seen in humans after smoking cessation, and find the mechanism by which the gut microbiome contributes to this phenomenon. |
ERAN ELINAV; | 2023-05-01 |
| 114 | Phase Ib Clinical Trial to Evaluate The Safety and Efficacy of TQB2618 Injection Combined Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To investigate the efficacy and safety of TQB2618 injection combined Penpulimab and chemotherapy in the first-line treatment of recurrent/metastatic esophageal squamous cell carcinoma compared with Penpulimab combined chemotherapy. The primary efficacy outcomes are progression free survival (PFS) and objective response rate (ORR). |
CHIA TAI TIANQING PHARMACEUTICAL GROUP | 2023-05-01 |
| 115 | A Phase 1 Open-label Single Ascending Dose Study to Evaluate The Pharmacokinetics, Safety and Tolerability of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants Following Subcutaneous Administration Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 following single ascending dose subcutaneous (SC) administration to healthy Chinese participants. |
JANSSEN RESEARCH & DEVELOPMENT | 2023-05-01 |
| 116 | Control Gait Analysis in Clubfoot Children and Comparison With Their Healthy Twins PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Children with clubfeet who were exclusively treated by Ursula Issler-Wüthrich for 3 to 14 years with manual-dynamic physiotherapy and their healthy twin siblings are compared using gait analysis. GaitUp sensors (kinematic) and footscan V9 (kinetic) are the systems used for this comparison. Nonparametric statistics are applied to verify aberrations. |
DR JOLLER BIOMEDICAL CONSULTING | 2023-04-29 |
| 117 | A Phase 1/2, Randomized, Dose-finding/Dose-confirmation Study to Evaluate The Reactogenicity, Safety and Immunogenicity of MRNA-based Multivalent Seasonal Influenza Vaccine Candidates Administered in Healthy Younger and Older Adults PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to find and confirm the dose and asses the reactogenicity, safety and immune response of GlaxoSmithKline’s (GSK) messenger RNA (mRNA)-based multivalent seasonal influenza vaccine (GSK4382276A) candidates administered in healthy younger and older adults (OA). |
GLAXOSMITHKLINE | 2023-04-27 |
| 118 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Evaluating The Efficacy and Safety of Daxdilimab in Adult Participants With Active Proliferative Lupus Nephritis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Phase 2, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of daxdilimab in patients with active, proliferative lupus nephritis (LN). |
AMGEN | 2023-04-26 |
| 119 | A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50% PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a study drug, and together be called study drugs. The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer. The study is looking at several other research questions, … |
REGENERON PHARMACEUTICALS | 2023-04-21 |
| 120 | VITAS: Atezolizumab in Combination with Chemotherapy for Pediatric Relapsed/refractory Solid Tumors: An Open-label, Phase II, Single-arm, Multi-center Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is a multi-center, non-randomized, open-label Phase I/II study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors. |
MATTHEW CAMPBELL; | 2023-04-18 |
| 121 | A Randomized, Open-Label Study on The Effect of Nipocalimab on Vaccine Responses in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the effect of nipocalimab treatment on the antibody (a protein made in the body to response to a foreign substance) response following tetanus, diphtheria, pertussis (Tdap) vaccination in healthy participants at Week 4. |
JANSSEN RESEARCH & DEVELOPMENT | 2023-04-12 |
| 122 | Systems Biological Assessment of The Durability of Vaccine Responses PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, … |
NADINE ROUPHAEL; | 2023-04-11 |
| 123 | ADI-PEG 20 in Combination With Gemcitabine and Docetaxel After Progression on Frontline Therapy in Non-small Cell and Small Cell Lung Cancers PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, patients with small cell or non-small cell lung cancer will receive ADI-PEG 20, gemcitabine, and docetaxel after demonstrated progression on frontline therapy. In phase I of the study, up to 6 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. Although safety and tolerability has been previously determined in the sarcoma population, dose de-escalations of the chemotherapies in that patient population were required. Therefore, … |
BRIAN A VAN TINE; | 2023-04-05 |
| 124 | A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell responsible for fighting infections. The purpose of this study is to assess safety, tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy. ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies. Study doctors put the participants in groups called treatment arms. Participants will receive ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the study across sites worldwide. In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In part 2 (dose optimization), … |
ABBVIE | 2023-04-04 |
| 125 | A Phase 1/2, Multicenter, Open-label Study of IBI354 in Subjects with Locally Advanced Unresectable or Metastatic Solid Tumors PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1/2, open-label, multicenter study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI354 (study drug), and to explore and confirm the efficacy, safety and tolerability of IBI354 in subjects with locally advanced unresectable or metastatic solid tumors. |
INNOVENT BIOLOGICS SUZHOU | 2023-04-04 |
| 126 | A Phase 1/2, Randomized, Open-Label Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of MRNA-1011.1, MRNA-1011.2, and MRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants. |
MODERNATX | 2023-03-27 |
| 127 | A Prospective Clinical Study of Chemotherapy Plus Programmed Death-1 Monoclonal Antibody in The Treatment of Refractory or Relapsed Peripheral T Cell Lymphoma Not Otherwise Specified and Angioimmunoblastic T-cell Lymphoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A multi-center, prospective clinical study to evaluate the efficacy and safety of R-GDP plus PD-1 monoclonal antibody in the treatment of refractory or relapsed peripheral T cell lymphoma not otherwise specified and Angioimmunoblastic T-cell lymphoma, which has previously shown promising efficacy. |
OU BAI; | 2023-03-23 |
| 128 | A Phase 2b, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of TAK-755 (rADAMTS13) With Minimal to No Plasma Exchange (PEX) in The Treatment of Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months. |
TAKEDA | 2023-03-21 |
| 129 | A Phase 1 Study of ASP1002 in Participants With Metastatic or Locally Advanced Solid Tumors PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aims of this study are: * To check the safety of ASP1002 in people with certain solid tumors. * To check if the people can tolerate ASP1002. * To find a suitable dose of ASP1002. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study. In Part 2, … |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2023-03-13 |
| 130 | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate The Efficacy and Safety of Fazirsiran in The Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to learn if fazirsiran reduces liver scarring (fibrosis) compared to placebo. Other aims are to learn if fazirsiran slows down the disease worsening in the liver, to get information on how fazirsiran affects the body (called pharmacodynamics), to learn if fazirsiran reduces other liver injury (inflammation) and the abnormal Z-AAT protein in the liver, to get information on how the body processes fazirsiran (called pharmacokinetics), … |
MEAGAN GRAY; | 2023-03-06 |
| 131 | Samtasu Post-marketing General Drug Use-results Survey in Patients with Volume Overload in Heart Failure PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: To confirm the safety of tolvaptan sodium phosphate in patients with volume overload in heart failure. |
OTSUKA PHARMACEUTICAL | 2023-03-03 |
| 132 | A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate The Safety and Effectiveness of Belotero® Intense Lidocaine for Lip Augmentation PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate the safety and effectiveness of Belotero Intense Lidocaine (BIL) for lip augmentation in subjects with upper and/or lower lip deficit. |
MERZ NORTH AMERICA | 2023-03-03 |
| 133 | A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Efficacy and Safety of Telitacicept in Lupus Nephritis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis. |
REMEGEN | 2023-03-01 |
| 134 | A Randomized, Open, Multicenter Phase 1/Phase 2 Clinical Trial of TQB2618 Injection Combined With Penpulimab Injection and Chemotherapy Versus Penpulimab Injection Combined With Chemotherapy in First-line Treatment of Relapsed/Metastatic Head and Neck Squamous Cell Carcinoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab and chemotherapy in the first-line treatment of relapsed/metastatic head and neck squamous cell carcinoma compared to Penpulimab combined chemotherapy. Progression-free survival (PFS) and objective response rate (ORR) were the primary efficacy endpoints. |
CHIA TAI TIANQING PHARMACEUTICAL GROUP | 2023-03-01 |
| 135 | TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-STUDY B (ARV-471 IN COMBINATION WITH RIBOCICLIB) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy * is sensitive to hormonal therapy (it is called estrogen receptor positive); … |
PFIZER | 2023-03-01 |
| 136 | TACTIVE-U: An Interventional Safety and Efficacy Phase 1b/2, Open-label Umbrella Study to Investigate Tolerability, Pk, and Antitumor Activity of Vepdegestrant (ARV-471/PF-07850327), An Oral Proteolysis Targeting Chimera, in Combination With Other Anticancer Treatments in Participants Aged 18 Years and Over With ER+ Advanced or Metastatic Breast Cancer, Sub-study A (ARV-471 in Combination With Abemaciclib) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called ARV-471) when given together with other medicines for the potential treatment of advanced or metastatic breast cancer. This study is seeking participants who have breast cancer that: * is advanced, may have spread to other organs (metastatic) and cannot be fully treated by surgery or radiation therapy * is sensitive to hormonal therapy (it is called estrogen receptor positive); … |
PFIZER | 2023-02-23 |
| 137 | A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing The Efficacy and Safety of Two Dose Regimens of JNJ-64281802 for The Prevention of Dengue Infection PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline. |
JANSSEN RESEARCH & DEVELOPMENT | 2023-02-22 |
| 138 | Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: A Pooled Analysis From The European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Raltegravir is the preferred INSTI for for treatment of antiretroviral-naïve pregnant women in the US Perinatal Guidelines, alongside Dolutegravir, and for late pregnancy. There are relatively limited information available on its use during early pregnancy, particularly the peri-conception period. The aim of the study is to assess real-world maternal, fetal and newborn outcomes following RAL use during pregnancy through pooled analysis of individual patient data from observational studies participating in the European Pregnancy and Paediatric Infections Cohort Collaboration. |
FONDAZIONE PENTA UK | 2023-02-20 |
| 139 | A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate The Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 18 to 64 Years of Age With Increased Risk for Pneumococcal Disease PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with V116 and PCV15 (a pneumococcal conjugate vaccine that includes 15 serotypes) + PPSV23 (comprised of the polysaccharides from 23 of the serotypes causing disease in adults) post-vaccination within each vaccination group separately. |
MERCK SHARP & DOHME | 2023-02-13 |
| 140 | An Open-label, Multicenter, Roll-over Study for Patients Who Have Completed A Prior Novartis-sponsored Sabatolimab (MBG453) Study and Are Judged By The Investigator to Benefit From Continued Treatment With Sabatolimab PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is intended to collect safety data from participants who completed the parent protocols but are still benefiting from study treatment. The study population consists of participants who tolerate study treatment of the parent studies. Collecting safety information from long-term exposure might offer the unique opportunity to detect rare Adverse Events. |
NOVARTIS PHARMACEUTICALS | 2023-02-13 |
| 141 | A Multi-Center Evaluation of The ECHELON™ 3000 (Next Generation Powered Stapler) in General Abdominal and Thoracic Lung Resection Procedures PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and performance of the ECHELON 3000 Stapler (next generation powered stapler) and reload system in participants undergoing laparoscopic sleeve gastrectomy or lung resection procedures (Video-Assisted Thoracoscopic [ATS] or open approach). |
ETHICON ENDO SURGERY | 2023-01-30 |
| 142 | A Phase 1/2, Multicenter, Open-Label, Randomized Dose Ranging and Expansion Study of The Combination of Gilteritinib, Venetoclax and Azacitidine in Patients With Newly Diagnosed FLT3 Mutated Acute Myeloid Leukemia (AML) Not Eligible for Intensive Induction Chemotherapy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: People with acute myeloid leukemia (AML) are usually treated with chemotherapy. Some people with AML have a changed FLT3 gene which causes leukemia cells to grow faster. Therefore, chemotherapy is less suitable to treat AML in people with the changed FLT3 gene. Gilteritinib, given with venetoclax and azacitidine, is a potential new treatment for people with AML with the changed FLT3 gene. They cannot have chemotherapy due to old age or other conditions. Before these combined 3 medicines are available as a treatment, … |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2023-01-27 |
| 143 | An Open Label, Two-Arm Study in Subjects With Chorioretinal Vascular Disease to Evaluate ABP 938 and Aflibercept (Eylea®) in A Prefilled Syringe PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to is to assess the ability of retina specialists to successfully administer, via an intravitreal (IVT) injection, a 2 mg dose of ABP 938, using the ABP 938 aflibercept prefilled syringe (PFS), compared to a 2 mg dose of aflibercept using the aflibercept PFS. |
AMGEN | 2023-01-23 |
| 144 | A Phase 3 Trial of Fianlimab (Anti-LAG-3) and Cemiplimab Versus Pembrolizumab in The Adjuvant Setting in Patients With Completely Resected High-risk Melanoma PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a study drug or called study drugs when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life. |
REGENERON PHARMACEUTICALS | 2023-01-16 |
| 145 | Miscarriage Preventing Herbal Medicines and The Risk of Birth Defects: A Population-based Cohort Study PF:10 Related Papers Related Patents Related Grants Related Experts View Highlight: Using data from a population-based medicine use cohort in Xiamen, China, this retrospective cohort study will investigate whether herbal medicines used to prevent miscarriage are associated with increased risk of birth defects. |
SUN XIN; | 2023-01-01 |
| 146 | A 24-week Multicenter, Open-label, Single-arm Study to Evaluate Safety in Patients With Type 2 Diabetes Mellitus in India Treated With Dulaglutide PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to evaluate safety of dulaglutide in participants with type 2 diabetes mellitus in India. |
ELI LILLY | 2022-12-29 |
| 147 | An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Evaluate The Relative Bioavailability of Staccato Alprazolam Compared to Oral Alprazolam in Healthy Study Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the relative bioavailability of alprazolam in plasma following a single dose of Staccato alprazolam compared to a single dose of oral alprazolam under fasted conditions |
UCB BIOPHARMA SRL | 2022-12-28 |
| 148 | A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-12-15 |
| 149 | A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician’s Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants With Relapsed or Refractory Mantle Cell Lymphoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-12-06 |
| 150 | A Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Study Evaluating The Pharmacokinetics and Safety of GFH312 in Healthy Chinese Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects. |
LU YONGNING; | 2022-11-29 |
| 151 | Ability of A Virtual-reality Based Solution Aiming to Reduce Patient Burden Related to Repetitive Intravenous Perfusions. A Proof-of-concept Study in Hemophilia Patients Receiving Prophylactic Factor VIII Infusions PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim is to describe how the treatment burden and challenges of participants, relatives, and doctors during regular Factor VIII infusions to treat hemophilia evolve using a virtual-reality (VR) based solution. The study also aims to find out how well the VR based solution is tolerated and how satisfied the participants, relatives, and doctors are with it. The VR based solution includes a mobile phone app and a 3D mask. Participants will use the VR based solution while receiving prophylactic Factor VIII infusions for 4 weeks at home. Participants will visit the clinic for the last infusion; … |
TAKEDA | 2022-11-24 |
| 152 | An Open Label, Single Arm Study to Evaluate Single and Multiple Dose Pharmacokinetics, Safety and Tolerability, and to Explore Clinical Outcomes of Treatment With Intravenous (IV) Zanamivir in Neonates and Infants Under 6 Months of Age With Confirmed Complicated Influenza Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Influenza infection is an important public health priority, with seasonal outbreaks and pandemics causing considerable global morbidity and mortality. The PK, pharmacodynamics (PD), safety and efficacy of IV zanamivir have been evaluated in adults, adolescents and infants more than or equal to (\>=) 6 months of age with hospitalized influenza in the IV zanamivir global development program. However, antiviral treatment of neonates and infants under 6 months of age hospitalized with influenza infection remains a medical unmet need. Given the immaturity of the immune system at this age, … |
LEILA BIANCHI; | 2022-11-21 |
| 153 | A Multicenter, Open-label, Phase III Study to Assess The Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effect of macitentan on hemodynamic measures at Week 24 in pediatric populations. |
JANSSEN PHARMACEUTICAL K K | 2022-11-14 |
| 154 | A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate The Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older. The polyvalent (23-valent) pneumococcal vaccine, PPSV23, is the active comparator. In addition to studying safety/tolerability, it is hypothesized that, at 30 days postvaccination, the immunogenicity of V116 is noninferior to PPSV23 for the 12 common serotypes in V116 and PPSV23, … |
MERCK SHARP & DOHME | 2022-11-07 |
| 155 | A Phase 2a/2b, Open-label, Proof of Concept (Phase 2a) and Open-label (Phase 2b), Multicenter, Efficacy, and Safety Study of AG-946 in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This purpose of this study is to establish proof of concept of tebapivat in participants with LR-MDS in Phase 2a and to evaluate the effect of tebapivat on transfusion independence (TI) in participants with LR-MDS in phase 2b. |
AGIOS PHARMACEUTICALS | 2022-11-07 |
| 156 | A Prospective, Multicenter, Interventional, Open-Label, Single-arm Phase IV Study Over 24 Weeks to Investigate The Radiological Onset of Action After Treatment Initiation With Subcutaneous Natalizumab in Patients With Relapsing-Remitting Multiple Sclerosis (TYS-ON) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the radiological efficacy of SC natalizumab over time through Week 24 in natalizumab-naïve participants, as measured by brain magnetic resonance imaging (MRI). The secondary objectives of this study are to evaluate additional lesion-related radiological efficacy measures over time, relapse-based clinical efficacy measures, disability improvement and worsening (EDSS), pharmacokinetic and pharmacodynamic parameters, the immunogenicity of repeated doses, and safety in treatment-naïve participants of SC natalizumab. |
BIOGEN | 2022-11-01 |
| 157 | A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate The Non-inferiority of The Immune Response and Safety of The RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to demonstrate the non-inferiority (NI) of the immune response and evaluate safety of RSVPreF3 older adults (OA) investigational vaccine in adults 50-59 years of age (YOA), including those who are at increased risk (AIR) of respiratory syncytial virus (RSV)-lower respiratory tract disease (LRTD), versus adults \>=60 YOA |
GLAXOSMITHKLINE | 2022-10-28 |
| 158 | A Phase II Clinical Trial to Evaluate The Efficacy and Safety of TQB2618 Injection Combined With Penpulimab in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a phase II clinical trial to evaluate the efficacy and safety of TQB2618 injection combined with Penpulimab in patients with recurrent/metastatic nasopharyngeal carcinoma. This study is divided into two parts. The first part includes the safe introduction phase and the expansion phase. The second part is a randomized controlled study design, which is divided into two groups. The two parts of research are carried out at the same time |
CHIA TAI TIANQING PHARMACEUTICAL GROUP | 2022-10-27 |
| 159 | A Phase 4, Multi-centre, Randomized, Evaluator-blinded, Active-controlled Study to Determine The Incidence of Squamous Cell Carcinoma and Evaluate The Long-term Safety of Tirbanibulin 10 Mg/g Ointment and Diclofenac Sodium 3% Gel for The Treatment of Adult Patients With Actinic Keratosis on The Face or Scalp PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period. |
ALMIRALL S A | 2022-10-24 |
| 160 | A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE INTRAVENOUS AND MULTIPLE SUBCUTANEOUS AND INTRAVENOUS DOSES OF PF-07261271 IN HEALTHY PARTICIPANTS PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this clinical trial is to learn about the safety and effects of the study medicine PF-07261271 for the potential treatment of Inflammatory Bowel Disease. |
PFIZER | 2022-10-17 |
| 161 | A 12-week, Prospective, Open Label, Single Cohort Study to Evaluate The Real-world Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in A Single Inhaler (Trelegy Ellipta) in Symptomatic Chronic Obstructive Pulmonary Disease (COPD) Patients PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the effectiveness of TRELEGY ELLIPTA on health status in participants with symptomatic COPD. The secondary objective is to evaluate the effectiveness of TRELEGY ELLIPTA on dyspnea and lung function in participants with symptomatic COPD. |
LEI WU; | 2022-10-14 |
| 162 | A Randomized, Blinded, Placebo-Controlled, Phase 1 Single-Ascending-Dose Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of BIIB115 in Healthy Adult Male Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to evaluate the safety and tolerability of single ascending dose of BIIB115 administered via intrathecal (IT) bolus injection to healthy male participants. The secondary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of BIIB115 administered via IT bolus injection to healthy male participants. |
BIOGEN | 2022-10-10 |
| 163 | A Phase I/IIa, Open-label, Randomised, Controlled, Multi-country, Dose-escalation Study to Assess The Safety and Immunogenicity of AS37 in Combination With The Hepatitis B Surface Antigen (HBsAg), According to A 0-1 Month Schedule, in Healthy, HBs Naïve, Adults Aged 18-45 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is conducted to assess safety and immunogenicity of GSK’s HBsAg vaccine adjuvanted with GSK’s AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK’s AS37 adjuvant system from other approved adjuvant systems and from an aluminum-based adjuvant. |
GLAXOSMITHKLINE | 2022-10-04 |
| 164 | Pattern of Congenital Anomalies in Infants of Diabetic Mother PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to determine the pattern of congenital anomalies associated with maternal diabetes mellitus in newborns attending Assiut University children’s Hospital. |
MARINA ABD ELSABOUR ADLY; | 2022-10-01 |
| 165 | A Phase 1, Randomized, Open-Label, 2-Part Study to Evaluate The Safety and Pharmacokinetics of ETR028 Acetate and ETR029 Acetate in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this Phase 1 clinical study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of O2P (Oral Overdose Protected) hydrocodone prodrugs (ETR028 and ETR029) relative to hydrocodone bitartrate hemipentahydrate (HCBT) comparator following single oral doses in healthy adult subjects under fasted and fed conditions with naltrexone blockade |
LEELA VRISHABHENDRA; | 2022-09-27 |
| 166 | Microphthalmia, Anophthalmia, and Coloboma Genetic Epidemiology in Children PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The investigators are inviting families to take part in a research study that will help us better understand the physical characteristics associated with children who have Microphthalmia, Anophthalmia, and Coloboma (MAC) and how changes in their DNA sequence, called genetic mutations, play a role in the risk of developing MAC |
PHILIP J LUPO; | 2022-09-25 |
| 167 | Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate The Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-09-23 |
| 168 | Evaluate The Safety and Immunogenicity of The 9-valent Human Papillomavirus Recombinant Vaccine (Hansenula Polymorpha) in Chinese Male Aged 9-45 Years: A Randomized, Blinded and Placebo-Controlled Phase I Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the safety and tolerability of the 9vHPV vaccine in Chinese healthy male aged 9 to 45 years. |
SHANGHAI BOVAX BIOTECHNOLOGY | 2022-09-23 |
| 169 | A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D and Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (HR-MDS) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS. |
GLAXOSMITHKLINE | 2022-09-20 |
| 170 | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate The Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-09-19 |
| 171 | A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Congenital diaphragmatic hernia (CDH) occurs in approximately 1 in 3000 US live births, similar to the incidence seen within the Utah Birth Defects cohort. The diaphragmatic defect compromises lung growth and alters pulmonary vascular development. This is reflected postnatally as respiratory failure, pulmonary hypertension (PH) and overall cardiopulmonary dysfunction, particularly post-repair. Currently, optimal management of post-repair PH remains poorly investigated. Sildenafil citrate is a highly selective phosphodiesterase-5 inhibitor that increases cGMP levels, leading to smooth muscle relaxation and an anti-proliferative effect within the pulmonary vasculature. It is used off-label for many neonatal PH disorders, … |
MICHELLE YANG; | 2022-09-15 |
| 172 | Randomized, Placebo-controlled, Double-blinded, 2-parallel Arm, Clinical Trial Evaluating Ladarixin 400 Mg Bid As Adjunctive Therapy to Improve Glycemic Control in Overweight Insulin-resistant Patients With Type 1 Diabetes Related Papers Related Patents Related Grants Related Experts View Highlight: Primary objective – To determine whether oral ladarixin versus placebo adjunctive therapy improves glycemic control in overweight, insulin resistant (IR) adult subjects with type 1 diabetes (T1D). Secondary objectives * To ascertain the effect of ladarixin on glycemic variability as per CGM derived parameters. * To determine the safety of oral ladarixin versus placebo adjunctive therapy in overweight, IR adult subjects with T1D. |
PAOLO POZZILLI; | 2022-09-14 |
| 173 | A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate The Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine RDENVΔ30 [Live, Attenuated]) in Healthy Adults PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination. |
MERCK SHARP & DOHME | 2022-09-07 |
| 174 | A Phase III, Randomized, Blinded, Positive-controlled Study to Compare The Immunogenicity of Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris) in Healthy Female Subjects Aged 16-26 Years PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9. |
SHANGHAI ZERUN BIOTECHNOLOGY | 2022-09-01 |
| 175 | A Dose-Blinded Extension Study to Evaluate The Long-Term Efficacy, Safety, and Tolerability of UCB0599 in Study Participants With Parkinson’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson’s disease. |
UCB BIOPHARMA SRL | 2022-08-29 |
| 176 | A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With An Open-label Cohort to Assess The Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis Related Papers Related Patents Related Grants Related Experts View Highlight: A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort. |
KINEVANT SCIENCES | 2022-08-23 |
| 177 | A Phase 1, Open-label, Safety and Immunogenicity Study of A Booster Dose of The Investigational CV0501 MRNA COVID-19 Vaccine in Adults at Least 18 Years Old PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Prevention of COVID-19 caused by SARS-CoV-2. |
GLAXOSMITHKLINE | 2022-08-12 |
| 178 | A Phase 1 Randomized, Observer-blind, Dose-escalation Study to Evaluate The Safety, Reactogenicity and Immunogenicity of An MRNA-based Monovalent Influenza Vaccine Candidate in Healthy Younger and Older Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline’s (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in healthy younger adults (YA) and older adults (OA). |
GLAXOSMITHKLINE | 2022-08-09 |
| 179 | A Phase IIIb Randomized Open-label Study of Nirsevimab (Versus No Intervention) in Preventing Hospitalizations Due to Respiratory Syncytial Virus in Infants (HARMONIE) PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to determine the efficacy and safety of a single intramuscular (IM) dose of nirsevimab, compared to no intervention, for the prevention of hospitalizations due to lower respiratory tract infection (LRTI) caused by confirmed RSV infection (henceforth referred to as RSV LRTI hospitalizations) in all infants under 12 months of age who were not eligible to receive palivizumab. The visit frequency was 1 in-person dosing/randomization visit, … |
SANOFI PASTEUR A SANOFI COMPANY | 2022-08-08 |
| 180 | The Application of Targeted Sequencing in The Diagnosis of Neonatal Diseases PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: To investigate the application of NGS in neonatal disease screening and diagnosis, two studies was conducted (the other ID is: shercru-20220003). This study is to evaluate the application of NGS in the diagnosis of neonatal disease. |
LIN ZOU; | 2022-08-01 |
| 181 | Clinical Evaluation of Arrhythmia Mapping With A Globe-Shaped, High-Density, Multi-Electrode Mapping Catheter PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the performance and safety for the use of the investigational catheter for intracardiac mapping in the atria and ventricles. |
BIOSENSE WEBSTER | 2022-07-29 |
| 182 | A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate The Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn’s Disease PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-07-22 |
| 183 | A Randomized, Open-Label Phase 2 Study of The TORC 1/2 Inhibitor Sapanisertib in Relapsed/Refractory NFE2L2 (NRF2)-Mutated and Wild-Type (WT) Squamous Non-Small Cell Lung Cancer (sqNSCLC) Related Papers Related Patents Related Grants Related Experts View Highlight: This is a multicenter, randomized, open-label Phase 2 study of sapanisertib in biomarker-defined populations of sqNSCLC. Patients with NFE2L2 (the name for gene encoding the protein called NRF2)-mutated or wild-type sqNSCLC should have disease that has progressed on or after at least two prior systemic therapies for metastatic disease including platinum-doublet chemotherapy and a programmed cell death 1 ligand 1 (PD-L1) inhibitor. The study will evaluate sapanisertib monotherapy in patients with relapsed/refractory sqNSCLC as two separate groups: Group A: NFE2L2-mutated sqNSCLC and Group B: NFE2L2-WT sqNSCLC. |
PAUL PAIK; | 2022-07-21 |
| 184 | An Open-Label Uncontrolled Multicenter Study to Evaluate The Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-07-20 |
| 185 | A RANDOMIZED, OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ABROCITINIB 100 MG AND 200 MG TABLETS IN PARTICIPANTS AGED 12 YEARS AND OLDER WITH MODERATE TO SEVERE ATOPIC DERMATITIS IN INDIA PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this clinical trial is to learn about the safety and how well the study medicine (called Abrocitinib) works for the potential treatment of moderate to severe Atopic Dermatitis (AD) in India. AD, also known as atopic eczema, is a chronic, relapsing skin condition characterized by dry, … |
PFIZER | 2022-07-16 |
| 186 | A Phase 1, Multi-Center, Open-Label Study to Evaluate The Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of FHND5071 As A Single Agent in Adult Patients With Advanced Solid Tumors PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1, first-in-human, open-label dose-escalation study to determine the MTD and/or recommended Phase 2 dose (RP2D) and assess the DLT of FHND5071. The safety, tolerability, … |
JIANGSU CHIA TAI FENGHAI PHARMACEUTICAL | 2022-07-07 |
| 187 | A Phase 1, Open-label, Single Dose Study to Investigate Pharmacokinetics, Safety and Tolerability of JNJ-63733657 in Healthy Chinese Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-63733657 following single intravenous (IV) dose administration in healthy Chinese participants. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-06-27 |
| 188 | A 28-Day Randomized, Placebo-Controlled, Double-Blind, Parallel Groups and Normative Comparison Study to Evaluate The Effect of SAGE-718 on Functioning Capacity in Participants With Huntington’s Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of this study is to assess the magnitude of the baseline difference between participants with early Huntington’s Disease (HD) and healthy participants (HP) with respect to measures of cognitive performance and the effect of SAGE-718 on cognitive performance and functioning in participants with HD. |
SAGE THERAPEUTICS | 2022-06-22 |
| 189 | A Single-center, Open-label, Single-dose, Randomized, 2-way Crossover Phase 1 Study in Healthy Adult Participants to Assess The Bioequivalence of The Dispersible Final Market Image (FMI) Macitentan Tablet (4 X 2.5 Mg) and The Opsumit Tablet (10 Mg) in Fasted Conditions PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the bioequivalence of macitentan on the primary pharmacokinetics (PK) parameters between the dispersible final market image (FMI) macitentan tablet and the opsumit tablet in healthy adult participants in fasted conditions. |
ACTELION | 2022-06-22 |
| 190 | An Observational Study to Assess The Safety of Xospata® 40 Mg Tablet When Administered in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea. |
ASTELLAS PHARMA KOREA | 2022-06-17 |
| 191 | A Phase 2a Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Efficacy, Safety, and Tolerability of An Oral Tablet Formulation of JNJ-77242113 for The Treatment of Moderate-to-Severe Plaque Psoriasis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the efficacy of an oral tablet formulation of JNJ-77242113 compared with placebo in participants with moderate-to-severe plaque psoriasis. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-06-13 |
| 192 | A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, … |
ASTELLAS PHARMA | 2022-06-08 |
| 193 | A Phase 1/1b Study of ASP2138 As Monotherapy and in Combination With Pembrolizumab and MFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With MFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This tells the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, … |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2022-06-07 |
| 194 | Open-label, Phase 2 Study, Evaluating The Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA). Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant’s or investigator’s decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated. |
SANOFI | 2022-06-01 |
| 195 | A Single-center, Open-label, Single-dose, Randomized, 3-way Crossover Phase 1 Study in Healthy Adult Participants to Assess The Relative Oral Bioavailability of Macitentan 75 Mg As Two Different Test Formulations Compared to The Reference Formulation PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the rate and extent of absorption of a single oral dose of macitentan given as 2 test formulations compared to the reference formulation under fed conditions in healthy adult participants. |
ACTELION | 2022-05-25 |
| 196 | Open-label Study to Evaluate The Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis (PsO). |
JANSSEN RESEARCH & DEVELOPMENT | 2022-05-24 |
| 197 | A Phase 1, Open-Label, Dose-Escalation Trial to Evaluate The Safety, Reactogenicity, and Immunogenicity of The Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1, open-label, dose-escalation clinical trial to evaluate the safety, reactogenicity, and immunogenicity of the Sm-p80+GLA-SE vaccine candidate in healthy adults between 18 and 55 years of age. Forty-five subjects will receive a series of three intramuscular injections 28 days apart with dose based on group. Five treatment groups, each including nine subjects, will receive three intramuscular (IM) injections of 0.5 mL of the designated study product on either Days 1, 29, and 57 or on Days 1, 29, and 180 (Table 1). Group A (unadjuvanted comparator) will receive 100 micrograms Sm-p80 alone on Days 1, 29, … |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2022-05-23 |
| 198 | A Multicenter, Open Label, Long-term Safety Study of BHV3000 for The Acute Treatment of Migraine in Chinese Subjects PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine |
PFIZER | 2022-05-19 |
| 199 | A Phase 1, Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate The Pharmacokinetics, Pharmacodynamics and Safety of Vonoprazan (10 or 20 Mg Once Daily) in Adolescents With Symptomatic Gastroesophageal Reflux Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the pharmacokinetic profile of vonoprazan in adolescent participants with symptomatic gastroesophageal reflux disease (GERD). |
PHATHOM PHARMACEUTICALS | 2022-05-09 |
| 200 | An Open-label Study to Evaluate The Safety, Efficacy, and Pharmacokinetics of REPLAGAL® in Treatment-naïve Chinese Subjects With Fabry Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of the study is to assess the safety of REPLAGAL. Study participants will receive REPLAGAL as an intravenous infusion every other week for 52 weeks. Participants will visit their study clinic many times throughout the study. |
QIU ZHENGQING; | 2022-05-06 |
| 201 | A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention. |
ACTELION | 2022-05-04 |
| 202 | Protreat-Trial: Prophylactic Antiemetic Treatment of Opioid-induced Nausea and Vomiting (OINV) in Palliative Care: A Randomized Controlled Phase II Feasibility Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Palliative cancer patients with tumor pain often suffer from nausea and vomiting when starting pain therapy with opioids. The objective of the clinical pilot trial is to evaluate the efficacy and tolerability of palonosetron in the prophylactic treatment of opioid-induced nausea and vomiting. |
GERHILD BECKER; | 2022-05-03 |
| 203 | A Phase I ,Open, Multicenter Study to Assess The Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 in Patients With Advanced Solid Tumors PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is the first-in-human of ASKC202, which is an open-label, non-randomized, multicenter study with a dose escalation phase and a dose expansion phase. |
ZHOU CAICUN; | 2022-05-01 |
| 204 | Evaluation of The Effects of Tongue-Tie and Upper Lip-Tie on Breastfeeding With Ultrasound Measurements and The LATCH Breastfeeding Assessment Tool PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Tongue-tie and upper-lip tie have been linked to breastfeeding difficulties; however, the traditional evaluation tools that provide this information rely primarily on subjective assessments. In this context, ultrasound imaging has enabled an objective assessment of the sucking dynamics of infants. The aim of this study was to assess the impact of tongue-tie and upper lip-tie on sucking function in newborns via ultrasonography and other tools. Methods: This prospective cohort study included 67 newborns (25 with tongue-tie, 21 with upper lip-tie, and 21 control) as well as their mothers. The maxillary labial frenulum was evaluated according to Kotlow, … |
ANKARA YILDIRIM BEYAZIT UNIVERSITY | 2022-05-01 |
| 205 | A Multicenter, Randomized, Double-blind, Placebo/Positive-controlled Phase II Study to Evaluate The Efficacy and Safety of JMT103 in Postmenopausal Women With Osteoporosis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is to evaluate the efficacy and safety of JMT103 in the treatment of postmenopausal women with osteoporosis. |
WEIBO XIA; | 2022-04-21 |
| 206 | AJOVY Subcutaneous Injection Long-term Specified Use-results Survey PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected. |
OTSUKA PHARMACEUTICAL | 2022-04-20 |
| 207 | A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine The Efficacy and Safety of BIIB122 in Participants With Parkinson’s Disease PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, researchers will learn more about BIIB122 in participants with early-stage Parkinson’s disease (PD). The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study. The main objective of the study is to learn about the effect BIIB122 has on slowing down the worsening of PD symptoms. The main question researchers want to answer is: – … |
ERIKA DRIVER DUNCKLEY; | 2022-04-19 |
| 208 | STIMulation Cérébrale Profonde Chez Des Patients Souffrant D’Anorexie Mentale Résistante Et Sévère PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The somatic complications as well as the suicidal risk make Anorexia Nervosa (AN) the psychiatric disease with the highest mortality rate: the standardized mortality ratio is higher than 4 and 1 in 5 patients with AN who dies has committed suicide. Approximately 20% of patients suffering from AN evolves into a chronic form without prolonged remission. These patients are at high risk of serious complications (somatic and psychiatric). The peak incidence of AN lies between 15 and 19 years: patients suffering from severe and resistant AN are therefore mostly young people. At present, … |
CENTRE HOSPITALIER ST ANNE | 2022-04-14 |
| 209 | A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations of Various RSV.preF-based Vaccine Formulations in Adults Aged 60 Years and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate safety and immunogenicity of various respiratory syncytial virus (RSV) pre-Fusion (preF)-based vaccine components followed by expanded safety evaluation and durability/revaccination evaluation of the selected RSV preF-based vaccine formulation in participants aged greater than or equal to (\>=) 60 years in stable health. |
JANSSEN VACCINES & PREVENTION B V | 2022-04-13 |
| 210 | A Single-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess The Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants. |
UCB BIOPHARMA SRL | 2022-04-04 |
| 211 | To Evaluate The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JSI-1187 Capsule in The Treatment of Advanced Solid Tumors With MAPK Signaling Pathway Mutations PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: JSI-1187-101 phase 1 study |
LIN SHEN; | 2022-04-02 |
| 212 | A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE). |
UCB BIOPHARMA SRL | 2022-03-30 |
| 213 | A Phase 1b Study Evaluating The Safety, Tolerability, Pharmacokinetics, and Efficacy of Bemarituzumab Monotherapy and Combination With Other Anti-Cancer Therapy in Subjects With Squamous-Cell Non-Small-Cell Lung Cancer (FORTITUDE-201) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies. |
AMGEN | 2022-03-29 |
| 214 | A Phase 3, Multicenter, Open-Label Study to Evaluate The Safety and Immunogenicity of 2-dose Regimens of 9vHPV and MRNA-1273 SARS-CoV-2 Vaccines Where The First Dose of Each Vaccine Are Given Concomitantly in Boys and Girls 9 to 11 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus nonconcomitant administration of 9vHPV and mRNA-1273 vaccines in boys and girls 9 to 11 years of age. |
MERCK SHARP & DOHME | 2022-03-28 |
| 215 | Maternal-fetal Immune Responses to Fetal Surgery PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Performing surgery in utero on fetuses with certain birth defects has led to significant improvements in outcomes after birth; however, many of these infants are born preterm which can decrease the effectiveness of these procedures. The investigators aim to understand the effects of surgery on the maternal and fetal immune system and whether immune activation may be causing some of these infants to be born prematurely. |
MAURO H. SCHENONE; | 2022-03-24 |
| 216 | An Open-Label, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given As 1x2mL or 2x1mL Subcutaneous Injection Using An Autoinjector in Healthy Study Participants PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to compare the pharmacokinetics (PK), safety and tolerability of a single subcutaneous (sc) dose of bimekizumab (BKZ) when administered using bimekizumab-autoinjector (AI)-2mL presentation versus bimekizumab-AI-2x1mL presentation in healthy study participants. |
UCB BIOPHARMA SRL | 2022-03-17 |
| 217 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate The Efficacy and Safety of ASLAN004 in Adult Patients With Moderate-to-Severe Atopic Dermatitis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Phase 2b study designed to evaluate the efficacy and safety of ASLAN004 in adult patients with moderate-to-severe Atopic Dermatitis (AD) who are candidates for systemic therapy. This study will have 5 treatment arms (4 active and 1 placebo). |
SUNIL DHAWAN; | 2022-03-16 |
| 218 | Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-03-09 |
| 219 | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Efficacy and Safety of Apremilast (AMG 407) in Japanese Subjects With Palmoplantar Pustulosis (PPP) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to evaluate the efficacy of apremilast (AMG 407) twice daily (BID) compared with placebo in participants with Palmoplantar Pustulosis (PPP). |
AMGEN | 2022-03-08 |
| 220 | A Phase 1/2A, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeat-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) Study to Investigate The Safety, Pharmacokinetics, and Efficacy (Part B Only) of UCB1381 in Healthy Study Participants (Part A) and in Study Participants With Moderate to Severe Atopic Dermatitis (Part B) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB1381 (intravenous and subcutaneous) in healthy study participants and after repeat intravenous dosing in study participants with atopic dermatitis. Efficacy will be assessed following repeat intravenous dosing versus placebo in study participants with atopic dermatitis. |
UCB BIOPHARMA SRL | 2022-03-07 |
| 221 | A Randomized, Double-Blind, Placebo-Controlled Study to Investigate The Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. |
HOFFMANN LA ROCHE | 2022-03-01 |
| 222 | An Open-Label, Parallel-Group, Phase 1 Study to Evaluate The Pharmacokinetics, Safety, and Tolerability of BIIB122 in Healthy Adult Japanese, Chinese, and Caucasian Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The study will be looking at an investigational drug, BIIB122, in healthy adult Japanese, Chinese, and Caucasian participants. The main goal of the study is to compare the drug level achieved in the body, between the different ethnic groups, after single and multiple doses of BIIB122. Researchers also want to see if single and multiple doses of BIIB122 are safe and if healthy participants can tolerate given doses of BIIB122. |
BIOGEN | 2022-02-17 |
| 223 | Study to Assess The Clinical Validity of Konectom™ in Adults Living With Neuromuscular Disorders PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments. The secondary objectives of this study are to evaluate the test-retest reliability of smartphone-based Konectom Digital Outcome Assessments (DOAs); to determine the relationship between Konectom upper limb DOAs and conventional upper limb assessments in clinical environments; to determine the relationship between Konectom lower limb DOAs and status of ambulation in clinical environments; … |
MED. TIM HAGENACKER; | 2022-02-10 |
| 224 | A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate The Efficacy and Safety of JNJ-77242113 for The Treatment of Moderate-to-Severe Plaque Psoriasis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Th purpose of the study is to evaluate the dose response of JNJ-77242113 in efficacy at Week 16 in participants with moderate-to-severe plaque psoriasis. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-02-03 |
| 225 | An Open-Label, Multicenter, Outpatient Extension Study to Evaluate The Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the long-term safety and tolerability of Staccato alprazolam. |
UCB BIOPHARMA SRL | 2022-02-03 |
| 226 | A Phase III, Randomized, Open-label, Active Vaccine-controlled Crossover Study to Evaluate The Reactogenicity, Safety and Immune Response of Unadjuvanted RSV Maternal Vaccine in Healthy Non-pregnant Girls From 9 to 17 Years of Age, and in Non-pregnant Adult Women From 18 to 49 Years of Age Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the reactogenicity, safety and immune response of a single intramuscular dose of the respiratory syncytial virus maternal (RSV MAT) vaccine in healthy non-pregnant girls 9-17 years of age (YOA) compared to non-pregnant adult women 18-49 YOA. The combined reduced-antigen-content diphtheria, tetanus and acellular pertussis (dTpa) vaccine will be used as an active control for safety and reactogenicity evaluation. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), … |
GLAXOSMITHKLINE | 2022-02-02 |
| 227 | A Phase 1/1b/2 Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 193 Alone and in Combination With Docetaxel in Subjects With Advanced MTAP-null Solid Tumors PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors. The primary objective of Part 3 of this study is to evaluate the efficacy of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors. |
AMGEN | 2022-02-01 |
| 228 | A Randomized, Open-Label, Parallel-Arm Study to Assess The Pharmacokinetic Comparability of 2 Fixed Subcutaneous Doses of Aducanumab (BIIB037) With A Single, Weight-Based Intravenous Dose in Healthy Volunteers PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to evaluate the pharmacokinetic (PK) comparability of 2 fixed subcutaneous (SC) doses of aducanumab with a single, weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of the study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional PK parameters of 2 fixed SC doses of aducanumab and a single, weight-based IV dose of aducanumab. |
BIOGEN | 2022-02-01 |
| 229 | A Retrospective Study for Congenital Hand and Upper Extremity Malformations in Assiut University Hospital During The Last Twenty Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Getting the incidence of upper limb anomalies in our department from 2000 to 2020 and classifying them using IFSSH classification and OMT classification |
SHADY MAGDY MAKAR SALIEB; | 2022-02-01 |
| 230 | A Phase 1/2 Study to Assess The Safety and Efficacy of OCU400 for Retinitis Pigmentosa Associated With NR2E3 and RHO Mutations and Leber Congenital Amaurosis With Mutation(s) in CEP290 Gene PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU400 in patients with retinitis pigmentosa associated with NR2E3 and RHO mutations and in patients with LCA due to mutation(s) in CEP290 gene (OCU400-101). To document prospective eye pathology in the above subjects Investigators will also conduct a Natural History Study (OCU400-104)i This is a multicenter study, which will be conducted in two phases and will enroll up to a total of 24 subjects in the OCU400-101 and 100 subjects in the OCU400-104 study. |
OCUGEN | 2022-01-24 |
| 231 | A Phase 3b Study to Evaluate Higher Dose Nusinersen (BIIB058) in Patients With Spinal Muscular Atrophy Previously Treated With Risdiplam PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, researchers will learn more about the use of a higher dose of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study will focus on teenagers and adults who are unable to walk on their own and who have previously taken another drug for SMA called risdiplam. The main goal of this study is to learn about the effect of high dose (HD) nusinersen on muscle and movement ability (motor function) in SMA. The main question that researchers want to answer is: – … |
SHAFEEQ S. LADHA; | 2022-01-21 |
| 232 | A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate The Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Crohn’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn’s disease. |
JANSSEN RESEARCH & DEVELOPMENT | 2022-01-19 |
| 233 | The Clinical Cohort Study of Reproductive Health PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The study will conduct a multicenter prospective clinical cohort study to collect comprehensive health information and essential specimens from pre-pregnancy to postpartum offspring development. We will combine the reproductive medicine with the big data technologies and cloud computing to explore the key factors which will induce the occurrence the reproductive disorders and effect the health of women and offspring. Based on the discovery of the cohort study, we will construct a prediction model for improvement of ART，optimizing the effectiveness and safety of ART. |
DAN ZHANG; | 2022-01-01 |
| 234 | Safety and Tolerability of VGB-R04 in Patients With Haemophilia B Related Papers Related Patents Related Grants Related Experts View Highlight: An Open-Label, Non-Randomized, uncontrolled, single-dose pilot study of VGB-R04 in subjects with Hemophilia B. |
LEI ZHANG; | 2021-12-28 |
| 235 | General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During The Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine. The number of visits to the clinic will depend on the clinic’s standard practice. |
MODERNATX | 2021-12-22 |
| 236 | A Phase I Open-label, Dose Escalation Study to Investigate The Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of The FHND6091 in Subjects With Relapsed/Refractory Multiple Myeloma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a phase I, first in human, single arm, open label study that will assess safety, tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM).The study will consist of two parts: dose escalation (Part 1) and dose expansion (Part 2).The dose escalation (Part 1) of the study will evaluate the safety and tolerability of FHND6091 using a dose escalation scheme to establish a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). And the dose expansion (Part B) of the study will further evaluate the safety, pharmacokinetics (PK)/ pharmacodynamics (PD), and efficacy of FHND6091 at two selected dose levels to characterize the safety, tolerability and efficacy of FHND6091. A total of 40 evaluable participants will be enrolled in the study. The participants receiving treatment in part 1 and part 2 may continue combination treatment for a total of up to 12 cycles. After 12 cycles of therapy, the participants will continue treatment until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study based on the judgement of investigator’s assessment. |
JIANQIN MI; | 2021-12-22 |
| 237 | A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating The Efficacy and Safety of Mitapivat in Subjects With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (ENERGIZE) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of this study was to compare the effect of mitapivat versus placebo on hemolytic anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT). |
AGIOS PHARMACEUTICALS | 2021-12-20 |
| 238 | A Phase 1, Randomized, Open-Label, Parallel-Arm Study to Evaluate The Relative Bioavailability of Two Formulations of BIIB104 and Assess The Effect of Food on The Pharmacokinetics of BIIB104 Following Administration of A Single, Fixed, Oral Dose of BIIB104 in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants. The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration. |
BIOGEN | 2021-12-15 |
| 239 | Phase I Clinical Trial to Evaluate Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A phase I clinical trial of tolerability and pharmacokinetics of TQB2858 injection in subjects with advanced malignancy. |
CHIA TAI TIANQING PHARMACEUTICAL GROUP | 2021-12-09 |
| 240 | An Open-Label, Parallel-Group, Phase 1 Study to Evaluate The Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (BIIB098) in Chinese and Caucasian Adult Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, … |
BIOGEN | 2021-12-03 |
| 241 | A Single-arm, Multicenter Phase II Clinical Trial to Evaluate TQB2858 Injection Combined With Anlotinib Hydrochloride Capsule in The Treatment of Recurrent or Metastatic Advanced Endometrial Cancer PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A clinical trial to evaluate TQB2858 injection combined with Anlotinib Hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial carcinoma |
CHIA TAI TIANQING PHARMACEUTICAL GROUP | 2021-12-01 |
| 242 | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess The Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective of the study is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants. |
BIOGEN | 2021-11-23 |
| 243 | International Collaboration for Real-World Evidence in Alzheimer’s Disease (ICARE AD)- A Prospective Real-World Observational Study of Aducanumab-avwa in Patients With Alzheimer’s Disease in The US PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the US. Investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (SoC). Participants will be followed up to 5 years after enrollment and data will be collected at routine visits every 6 to 12 months. |
BIOGEN | 2021-11-18 |
| 244 | A Phase 3b, Multicenter, Open-label Study to Evaluate The Immune Response To, and The Safety Of, Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Oral Ozanimod Compared to Non-pegylated Interferon (IFN)-β or No Disease Modifying Therapy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is designed to provide data on the immune response and safety of administering vaccines to relapsing multiple sclerosis (RMS) participants taking ozanimod compared to controls taking interferon-beta’s or receiving no disease modifying therapies (DMTs). The data of this study will support the labels for ozanimod in multiple sclerosis (MS) because the effect of ozanimod on the vaccination response of MS participants is of interest to participants and prescribers. |
CELGENE | 2021-11-11 |
| 245 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Safety and Efficacy of ASP8062 As An Add-on Therapy to Buprenorphine/Naloxone in Participants With Opioid Use Disorder Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy; safety and tolerability of ASP8062 compared with placebo ASP8062 as add-on therapy to buprenorphine/naloxone. |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2021-11-08 |
| 246 | A Pivotal Phase 3 Randomized, Placebo-controlled Clinical Study to Evaluate The Efficacy and Safety of The SGC Stimulator Vericiguat/MK-1242 in Adults With Chronic Heart Failure With Reduced Ejection Fraction PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization. |
MERCK SHARP & DOHME | 2021-11-02 |
| 247 | A Multicenter, Open-label, Phase 2, Extension Trial to Study The Long-term Safety in Participants With PROS or Proteus Syndrome Who Are Currently Being Treated With Miransertib in Other Studies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a study of the safety and tolerability of oral miransertib (MK-7075) administered to participants at least 2 years of age with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-related overgrowth spectrum (PROS) or Proteus Syndrome (PS). This is an extension of other miransertib studies (MK-7075-002 \[NCT03094832\] or ArQule CU/EAP \[NCT03317366\]), and may also enroll participants who are approved for MK-7075-002 but have not yet started miransertib therapy. |
MERCK SHARP & DOHME | 2021-11-02 |
| 248 | A Randomized, Double-blind Phase 3 Study to Assess The Immunogenicity and Safety of An Ad26.RSV.PreF-based Regimen at The End of Shelf-life in Adults Aged 60 to 75 Years PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses of Ad26.RSV.preF-based study vaccine lots representative of different aged vaccine in comparison to a non-aged Ad26.RSV.preF-based study vaccine lot. |
JANSSEN VACCINES & PREVENTION B V | 2021-11-01 |
| 249 | A Prospective, Observational Standard of Care Study of Patients With Major Depressive Disorder Who Have Had An Inadequate Response to A Selective Serotonin Reuptake /Serotonin-Norepinephrine Reuptake Inhibitor Antidepressant As A Control Arm for The Safety Assessments in The Seltorexant Phase 3 Program Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety (adverse events, serious adverse events, deaths, suicidality) of participants with major depressive disorder (MDD) treated according to the standard of care (SOC). |
JANSSEN RESEARCH & DEVELOPMENT | 2021-10-26 |
| 250 | A Multicenter, Double-blind, Placebo-controlled, Randomized, Multiple Dose Study to Assess The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of JNJ-67484703 in Participants With Active Rheumatoid Arthritis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate safety and tolerability of JNJ-67484703 administrations in participants with active rheumatoid arthritis (RA). |
JANSSEN RESEARCH & DEVELOPMENT | 2021-10-18 |
| 251 | Phase 1 Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of HG381 As Monotherapy in Patients With Advanced Solid Tumors PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase I, first in human, open-label, non-randomized, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy and establish a recommended dose of HG381 administered intravenously (IV) alone in subjects with advanced solid tumors. |
JIANMING XU; | 2021-10-18 |
| 252 | A Randomized, Double-blind Phase 3 Study to Compare The Immunogenicity of Clinical Trial Material of An Ad26.RSV.preF-based Vaccine for Phase 3 With Clinical Trial Material Representative of Phase 2b in Adults Aged 60 to 75 Years PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate non-inferiority in terms of humoral immune responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM) compared with one dose of the Phase 2b CTM. |
JANSSEN VACCINES & PREVENTION B V | 2021-10-08 |
| 253 | A Staged Phase I/II Observer-blind, Randomised, Controlled, Multi-country Study to Evaluate The Safety, Reactogenicity, and Immune Responses to The GVGH AltSonflex1-2-3 Vaccine Against S. Sonnei and S. Flexneri, Serotypes 1b, 2a, and 3a, in Adults in Europe (Stage 1) Followed By Age De-escalation From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of the current clinical study is to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine will be first administered in adults 18 to 50 years of age in Europe. Subsequently, the vaccine will be administered to a shigellosis-endemic population in Africa, first in adults 18 to 50 years of age, then in children 24 to 59 months of age, … |
GLAXOSMITHKLINE | 2021-10-06 |
| 254 | An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial is being done to see if an experimental drug (SEA-CD40) works when it’s given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug. There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can’t be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed. |
SEAGEN | 2021-10-06 |
| 255 | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate The Immunogenicity and Safety of Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately. |
JANSSEN VACCINES & PREVENTION B V | 2021-10-04 |
| 256 | A Randomized Trial of Quadruple Fortified Salt for Anemia and Birth Defects Prevention in Southern India PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Neural tube closure defects (NTDs) are a common adverse pregnancy outcome and among the most severe birth defects in the United States and globally. Women of reproductive age are a high-risk population for anemia and micronutrient deficiencies, and there is increasing evidence of the role of periconceptional nutritional status in the risk of birth defects and other common pregnancy complications. However, there is little representative population-level data from Southern India, … |
JULIA L FINKELSTEIN; | 2021-10-01 |
| 257 | TACTIC: A Phase II Study of TAS-102 Monotherapy and Thalidomide Plus TAS-102 As Third-line Therapy and Beyond in Patients With Advanced Colorectal Carcinoma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Thalidomide has both anti-angiogenesis and antiemetic effects, and its combined use with TAS-102 may reduce the gastrointestinal reactions associated with TAS-102, while enhancing antitumor efficacy and reducing the side effects of chemotherapy, and its cost is significantly lower than that of bevacizumab, which has higher pharmacoeconomics and greater clinical research application value. |
FUJIAN CANCER HOSPITAL | 2021-10-01 |
| 258 | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate The Safety and Immunogenicity of An Ad26.RSV.preF-based Vaccine in Adults Aged 18 to 59 Years, Including Those at High-risk for Severe RSV PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to investigate the safety and immunogenicity of the Ad26.RSV.preF based vaccine in adults 18 to 59 years of age who are healthy or at risk for severe Respiratory Syncytial Virus (RSV) disease, compared to adults 65 years and above. |
JANSSEN VACCINES & PREVENTION B V | 2021-09-29 |
| 259 | Assessment of Birth Outcomes in Eswatini After Transition to Dolutegravir-based Treatment PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this observational study is to assess the birth outcomes of HIV-positive women delivering in hospitals in Eswatini who are receiving dolutegravir (DTG) or other anti-retroviral (ARV) drug regimens. The main question the study aims to answer is, what is the proportion of neural tube defects among live and stillborn infants delivered by: – HIV-positive women on DTG at conception – HIV-negative women – HIV-positive women on non-DTG ARV at conception Participants will be interviewed for information on HIV testing and antiretroviral therapy history, other medical history of selected conditions (e.g., diabetes, malaria, … |
MICHELLE GILL; | 2021-09-07 |
| 260 | An Open Label Study to Evaluate The Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS). The participants of this study will have ALGS a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys. Common symptoms, which often develop during the first three months of life, include blockage of the flow of bile from the liver (cholestasis), yellowing of the skin and mucous membranes (jaundice), … |
WIKROM KARNSAKUL; | 2021-09-03 |
| 261 | A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacodynamic Markers, and Pharmacokinetics of AP-101 in Patients With Familial Amyotrophic Lateral Sclerosis (fALS) and Sporadic Amyotrophic Lateral Sclerosis (sALS) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety, tolerability, PK, and PD of AP-101 in participants with fALS and sALS. |
JOHN RAVITS; | 2021-09-02 |
| 262 | Post-Marketing Surveillance (Usage Results Study) of Adult Patients Treated With Lubiprostone for Indications Approved in South Korea PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to check the side effects from lubiprostone in adults with constipation. Participants will be treated with lubiprostone according to their clinic’s standard practice. |
YUN JEONG LIM; | 2021-09-01 |
| 263 | An Open-label, Phase 2 Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose schedule during the second and/or third trimester of pregnancy, 28 days after vaccination. |
JANSSEN VACCINES & PREVENTION B V | 2021-08-27 |
| 264 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE). |
JANSSEN RESEARCH & DEVELOPMENT | 2021-08-20 |
| 265 | A Phase 2 Study to Assess The Efficacy and Safety of AX-8 in Patients With Chronic Cough PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized, double-blind, placebo-controlled, crossover, multicenter study of AX-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of AX-8 in reducing cough frequency. |
AXALBION SA | 2021-08-11 |
| 266 | A Phase 1, Open-label, Sequential-group, Single-dose Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of AMG 592 Administered Subcutaneously in Healthy Chinese, Japanese, and Caucasian Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants. |
AMGEN | 2021-08-09 |
| 267 | A Randomized Controlled Trial of VE303 to Treat Hepatic Encephalopathy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy. Eligible participants will be enrolled and given oral antibiotics followed by 14 days of the study drug (placebo vs.VE303). There will be visits as well as other procedures to collect blood and stool samples, and have tests of your cognition (thinking) for this research study. The hypothesis is that VE303 will safely and effectively improve cognitive function in patients with a history of overt hepatic encephalopathy. |
PATRICIA BLOOM; | 2021-08-06 |
| 268 | A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With A 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate The Efficacy, Safety, and Tolerability of Brivaracetam As Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE). |
UCB BIOPHARMA SRL | 2021-07-29 |
| 269 | A Post Marketing Surveillance (PMS) Study for VPRIV (Velaglucerase Alfa) in India PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to measure the safety and to find out the effects of VPRIV in participants with Gaucher disease using both retrospective and prospective data when used in the post-marketing setting and to collect genetic mutation data from participants with Gaucher disease. This study is about collecting data available in the participant’s medical record as well as data from each participant’s ongoing treatment. No study medicines will be provided to participants in this study. When the participants start the study, they will visit the study clinic close to approximately 12 months. |
SHIRE | 2021-07-28 |
| 270 | Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Lanadelumab (Takhzyro®) in Patients Aged 12 Years and Older With Hereditary Angioedema (HAE) in Argentina PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to learn about the safety profile of lanadelumab in teenagers and adults with hereditary angioedema (HAE) in Argentina as part of routine routine practice. This study is about collecting data only. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. The study will collect data from the participant’s medical records. Participants do not need to visit their doctor in addition to their normal visits. |
RAUL BOZZO; | 2021-07-28 |
| 271 | A Multicenter, Open-Label Extension Study to Assess The Long-Term Safety and Tolerability of Dapirolizumab Pegol Treatment in Study Participants With Systemic Lupus Erythematosus PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate long-term safety and tolerability of dapirolizumab pegol treatment. |
UCB BIOPHARMA SRL | 2021-07-27 |
| 272 | A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of The Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed By Cardiac Magnetic Resonance Imaging Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (PAH). |
ACTELION | 2021-07-07 |
| 273 | A Randomized, Double-Blinded, Placebo Controlled Phase II Study to Evaluate The Safety and Efficacy of IV Ampion in Adult COVID-19 Patients Requiring Oxygen Supplementation PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 2 randomized study to evaluate the safety and efficacy of IV Ampion in improving the clinical course and outcomes of adult COVID-19 patients requiring supplemental oxygen. |
AMPIO PHARMACEUTICALS | 2021-07-05 |
| 274 | Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess The Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in The Prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease in Adults Aged 60 Years And Older With A History of Urinary Tract Infection in The Past 2 Years PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate the efficacy of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) compared to placebo in the prevention of the first invasive extraintestinal pathogenic Escherichia coli disease (IED) event caused by ExPEC9V O-serotypes. |
JANSSEN RESEARCH & DEVELOPMENT | 2021-06-30 |
| 275 | Adynovate Special Drug Use Result Survey (Perioperative Administration) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII. The aims of this study are as follows: – To check for side effects from TAK-660. – To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, … |
TAKEDA | 2021-06-30 |
| 276 | A Randomized, Open-Label, Parallel-Arm Study to Assess The Absolute Bioavailability of A Single, Fixed Subcutaneous Dose of Aducanumab (BIIB037) Compared to A Single, Weight-Based Intravenous Dose in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the absolute bioavailability of a single, fixed subcutaneous (SC) dose of aducanumab compared with a single weight-based intravenous (IV) dose of aducanumab in healthy volunteers. The secondary objectives of this study are to assess the safety and tolerability of aducanumab administered SC in healthy volunteers and to characterize additional pharmacokinetic (PK) parameters of a single, fixed SC dose of aducanumab and a weight-based IV dose of aducanumab in healthy volunteers. |
BIOGEN | 2021-06-30 |
| 277 | A Phase 3, Open-Label, Multicenter Study to Evaluate The Efficacy and Safety of Darvadstrocel in The Treatment of Complex Perianal Fistula in Pediatric Subjects With Crohn’s Disease Over A Period of 24 Weeks and An Extended Follow-up Period for A Total of Up to 52 Weeks Related Papers Related Patents Related Grants Related Experts View Highlight: A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present. The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel. 2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, … |
TAKEDA | 2021-06-30 |
| 278 | A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate The Safety and Efficacy of Inhaled Ampion in Adults With Respiratory Distress Due to COVID-19 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is phase II study to evaluate the safety and efficacy of inhaled Ampion in adults with respiratory distress due to COVID-19 |
AMPIO PHARMACEUTICALS | 2021-06-22 |
| 279 | A Randomized, Double-blind, Phase 3 Study to Evaluate 6 Dose Levels of Ad26.COV2.S Administered As A Two-Dose Schedule in Healthy Adults PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate non-inferiority (NI) in terms of humoral immune responses after 6 dose levels of Ad26.COV2.S. |
JANSSEN VACCINES & PREVENTION B V | 2021-06-18 |
| 280 | A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating The Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving The Signs and Symptoms and Inhibiting Radiographic Progression in Participants With Active Psoriatic Arthritis PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA. |
JANSSEN RESEARCH & DEVELOPMENT | 2021-06-17 |
| 281 | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Assess The Safety, Pharmacokinetics, Pharmacodynamics and Clinical Response of Guselkumab in Adult Participants With Celiac Disease Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and tolerability of guselkumab compared to placebo in participants with celiac disease. |
JANSSEN RESEARCH & DEVELOPMENT | 2021-06-17 |
| 282 | A Phase I/II, Randomised, Controlled Study to Assess The Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II) PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), … |
GLAXOSMITHKLINE | 2021-06-14 |
| 283 | Phase 1, Open-Label, Multicenter Study of Intramuscular PRL-02 Depot in Patients With Advanced Prostate Cancer PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Medicines that reduce the amount of testosterone in the body are commonly used to treat prostate cancer. PRL-02 depot is a potential treatment for men with advanced prostate cancer. It is given by an injection into the muscle. Men with advanced prostate cancer can take part in this study. Their cancer has come back after previous cancer treatment, … |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2021-06-14 |
| 284 | A Phase 1 Open-Label Study of Patritumab Deruxtecan in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study includes a Dose Escalation Part to identify the recommended combination dose (RCD) and a Dose Expansion Part to further evaluate efficacy and safety. The primary objectives: Dose Escalation: To assess the safety and tolerability of patritumab deruxtecan (U3-1402) and osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib, … |
DAIICHI SANKYO | 2021-06-11 |
| 285 | A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate The Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer’s Disease (AD), Followed By An Open-Label Extension Period PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer’s Disease (AD). |
UCB BIOPHARMA SRL | 2021-06-09 |
| 286 | Equfina Tablet 50 Mg Post Marketing Surveillance Protocol PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to describe the following in relation to the safety of Equfina Tablet 50 mg in the post marketing setting: 1. Serious adverse events (SAEs) and adverse drug reactions (ADRs) 2. Unexpected adverse events (AEs) and ADRs not reflected in the precautions for use 3. Known ADRs 4. Non-serious ADRs 5. Other safety and efficacy related information. |
EISAI KOREA | 2021-06-03 |
| 287 | A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating The Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS) |
UCB BIOPHARMA SRL | 2021-05-27 |
| 288 | A First-in-human, Phase I, Open-label Study of The ATM Inhibitor M4076 in Participants With Advanced Solid Tumors (DDRiver Solid Tumors 410) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), maximum tolerated dose (MTD) (if reached) and early signs of efficacy of M4076 monotherapy in participants with solid tumors in dose escalation (Part 1A). Once the recommended dose for expansion (RDE) was declared in Part 1A, a preliminary food effect cohort, Part 1B, will follow at the RDE determined from Part 1A. |
EMD SERONO RESEARCH & DEVELOPMENT INSTITUTE | 2021-05-24 |
| 289 | The Phase Ib/II Clinical Study of The Safety, Tolerability, Pharmacokinetics and Efficacy of Genakumab for Injection in Patients With Acute Gout PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the safety and tolerability of single subcutaneous injection of Genakumab for Injection in patients with acute gout |
HEJIAN ZOU; | 2021-05-22 |
| 290 | A PHASE 3, RANDOMIZED, DOUBLE BLIND TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF 20 VALENT PNEUMOCOCCAL CONJUGATE VACCINE WHEN COADMINISTERED WITH A BOOSTER DOSE OF BNT162b2 IN ADULTS 65 YEARS OF AGE AND OLDER PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered at the same visit or each vaccine given alone |
PFIZER | 2021-05-20 |
| 291 | A Phase 3, Open-label Clinical Study to Evaluate The Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9vHPV vaccine. No hypothesis will be tested since this study is an estimation-only study. |
MERCK SHARP & DOHME | 2021-05-17 |
| 292 | A Phase 3, Open-Label, Randomized Trial to Investigate The Immunogenicity and Safety of The Co-administration of A Subcutaneous Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and An Intramuscular Recombinant 9-Valent Human Papillomavirus (9vHPV) Vaccine in Subjects Aged ≥9 to <15 Years in An Endemic Country for Dengue PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine administered alone. |
TAKEDA | 2021-05-15 |
| 293 | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate The Efficacy and Safety of ANB019 in The Treatment of Acneiform Rash in Subjects With Neoplasm Receiving EGFRi or MEKi Therapy Related Papers Related Patents Related Grants Related Experts View Highlight: Efficacy and Safety of imsidolimab in participants with epidermal growth factor receptor inhibitor (EGFRi)/mitogen-activated protein (MAP)/extracellular signal-regulated kinase (ERK) kinase inhibitor (MEKi)-associated acneiform Rash |
ANAPTYSBIO | 2021-05-04 |
| 294 | Transition Care Model for Adolescents With Congenital Heart Disease (CHD): A Multicenter Study to Assess Its Effectiveness on Patient-reported Outcomes (TELEMACO Study) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary aim of this study is to assess the effectiveness of a standardized transition care model (TC) on the perceived mental and physical health of adolescents with congenital heart disease (CHD). Furthermore, the secondary aims of this research are focused on providing a description of the impact of a standardized TC on overall healthcare needs, satisfaction, and engagement. Therefore, a prospective, randomized, controlled, single-blind, and multi-center study will be conducted. |
SERENA FRANCESCA FLOCCO; | 2021-05-03 |
| 295 | A Multicenter, Single-arm, Open-label, Long-term Follow-up Safety Study of Selexipag in Participants Who Participated in A Previous Selexipag Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the long-term safety of selexipag while providing continued selexipag treatment for participants who were previously enrolled in an Actelion-sponsored study with selexipag and who derived benefit from selexipag in indications for which a positive benefit-risk has been established. |
ACTELION | 2021-05-03 |
| 296 | Fast-track Referral for Health Interventions During Pregnancy: A Randomized Pragmatic Experimental Study to Reduce Low Birthweight in Portugal PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Introduction: Low birthweight (LBW) is associated with a wide range of short- and long-term consequences and is related to a complex set of maternal psychosocial and behavioural determinants. The objective of this study is to assess the effect of implementing fast-track referral for early intervention on psychosocial and behavioural risk factors – smoking, alcohol consumption, depression and interpersonal violence – … |
INSTITUTO DE SAUDE PUBLICA DA UNIVERSIDADE DO PORTO | 2021-05-02 |
| 297 | A Single-arm, Multicenter Phase Ib Clinical Trial of The Efficacy and Safety of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Neoadjuvant in The Treatment of Resectable Hepatocellular Carcinoma With A High Risk of Recurrence or Metastasis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, single cell transcriptome sequencing will be performed on the tissue samples punctured and the surgically resected specimens to explore the gene mutation sites related to efficacy |
HONG ZHAO; | 2021-04-30 |
| 298 | A Multicenter, Open-Label Study to Evaluate The Pharmacokinetics, Tolerability, and Safety of A Single Dose of Staccato Alprazolam in Adolescent Study Participants With Epilepsy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the pharmacokinetics (PK), tolerability, and safety of Staccato alprazolam in adolescent study participants with epilepsy following single-dose administration. |
UCB BIOPHARMA SRL | 2021-04-28 |
| 299 | Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month. |
QING-LEI ZENG; | 2021-04-26 |
| 300 | A Multicenter, Interventional, Retrospective and Prospective Study of Enzyme Replacement Therapy (VPRIV) Clinical Outcomes and Safety in Gaucher Disease Type 1 Patients Previously Treated With Substrate Reduction Therapy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The study will provide information on outcomes in people with type 1 Gaucher disease when they are treated with velaglucarase alfa (also called VPRIV), under standard care. Standard care means the participant will be treated according to the clinic’s standard practice. The study sponsor will not be involved in how participants are treated with VPRIV, will provide instructions on how the clinic will record what happens during the study. VPRIV is a type of enzyme replacement therapy (also known as ERT). Before starting the study, … |
OZLEM GOKER-ALPAN; | 2021-04-22 |
| 301 | A Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in An Investigational Study With Nusinersen PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study is an extension study and will enroll only those participants who have completed treatment in the parent study, 232SM203. The main goal of the study is to learn about the long-term safety of nusinersen. The main questions researchers want to answer are: * How many participants have adverse events and serious adverse events during the study? * How do the results of electrocardiograms (ECGs), vital signs, … |
BIOGEN | 2021-04-19 |
| 302 | A Multicenter, Open-label Phase 2 Study to Evaluate The Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Patients With Selected Solid Tumors PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This was an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic, unresectable gastric cancer (GC), or colorectal cancer (CRC) or non-small cell lung cancer (NSCLC). The study was conducted in 2 parts. Part 1 was the safety run-in stage to determine dose-limiting toxicity (DLT) and recommended Phase 2 dose (RP2D). Part 2 assessed the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate (ORR) and other efficacy and safety profiles. |
BEIGENE | 2021-04-19 |
| 303 | A Single-Arm, Multicenter, Open-label Phase III Expansion Trial Evaluating Safety and Efficacy of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in Adolescent and Adult Patients With Hemophilia A PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of the study are to further evaluate the efficacy and safety of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW107) in adolescent and adult patients with hemophilia A. |
RENCHI YANG; | 2021-04-16 |
| 304 | A Randomized Controlled Study on Sequential Therapy of Kidney Tonifying and Blood Regulating Herbs to Improve The Success Rate of IVF-ET in Patients With Ovarian Reserve Dysfunction PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In the early stage, our team found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in vitro fertilization and embryo transfer(IVF-ET) can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility due to decreased ovarian reserve (DOR). A randomized controlled clinical trial was used in this study. 200 infertile patients with DOR were randomly divided into two groups. The control group was treated with conventional modern medicine, … |
PEKING UNIVERSITY THIRD HOSPITAL | 2021-04-15 |
| 305 | A Phase 3b, Prospective, Open-label, Multicenter, Single Treatment Arm, Continuation Study of The Safety and Efficacy of TAK-755 (rADAMTS13, Also Known As BAX 930/SHP655) in The Prophylactic and On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP; Upshaw-Schulman Syndrome, or Hereditary Thrombotic Thrombocytopenic Purpura) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Thrombotic thrombocytopenic purpura (or TTP for short) is a condition where blood clots form in small blood vessels throughout the body. The clots can limit or block the flow of oxygen-rich blood to the body’s organs, such as the brain, kidneys, and heart. As a result, serious health problems can develop. The increased clotting that occurs in TTP uses up the cells that help the blood to clot, called platelets. With fewer platelets available in the blood, bleeding problems can also occur. People who have TTP may bleed underneath the skin forming purple bruises, … |
ANA ANTUN; | 2021-04-14 |
| 306 | A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate The Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this phase 2b/3 double-blind, randomized, placebo-controlled study are to evaluate the efficacy and safety of clesrovimab in healthy pre-term and full-term infants. It is hypothesized that clesrovimab will reduce the incidence of respiratory syncytial virus (RSV)-associated medically attended lower respiratory infection (MALRI) from Days 1 through 150 postdose compared to placebo. |
MERCK SHARP & DOHME | 2021-04-07 |
| 307 | Abilify Prolonged Release Aqueous Suspension for Intramuscular Injection Specified Drug-use Results Survey (Prevention of Recurrence/relapse of Mood Episodes in Bipolar I Disorder) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of mood episodes in the routine clinical setting. The early stage safety after the switching from oral aripiprazole to this IM injection is investigated including extrapyramidal syndrome and malignant syndrome. Information regarding efficacy is collected as well. |
OTSUKA PHARMACEUTICAL | 2021-04-07 |
| 308 | A Phase 3 Study of The Efficacy, Safety, and Pharmacokinetics of Ustekinumab As Open-label Intravenous Induction Treatment Followed By Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Crohn’s Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active Crohn’s disease. |
JANSSEN RESEARCH & DEVELOPMENT | 2021-04-06 |
| 309 | A Prospective, Multi-center, Cohort Study to Evaluate The Efficacy and Safety of Tenofovir Alafenamide (TAF) for Prevention of Mother-to-child Transmission of Hepatitis B Virus Among Pregnant Women With High Level HBV DNA PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA. |
JINLIN HOU; | 2021-04-04 |
| 310 | A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2. – … |
BIONTECH SE | 2021-04-01 |
| 311 | An Exploratory, Open-label, Proof-of-concept, Phase 2a Study of Mavacamten (MYK-461) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Chronic Elevation of Cardiac Biomarkers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 2a proof-of-concept study to assess safety, tolerability, and preliminary efficacy of mavacamten treatment on biomarker levels in participants with heart failure with preserved ejection fraction (HFpEF) and elevation of NT-proBNP with or without elevation of cTnT. Data from this study will inform future study designs of mavacamten in patients with HFpEF. |
BRISTOL MYERS SQUIBB | 2021-03-30 |
| 312 | Drug Use Surveillance for Cabometyx Tablets Renal Cell Carcinoma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a survey in Japan of Cabozantinib tablets used to treat people with a type of kidney cancer called renal cell carcinoma. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. The main aim of the study is to check for side effects from Cabozantinib. During the study, participants with renal cell carcinoma will take Cabozantinib tablets according to their clinic’s standard practice. The study doctors will check for side effects from Cabozantinib for 26 weeks. |
TAKEDA | 2021-03-29 |
| 313 | Samsca Post-marketing General Drug Use-results Survey in Patients with Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan |
OTSUKA PHARMACEUTICAL | 2021-03-29 |
| 314 | Open-label, Multi-cohort, Phase 2 Trial, Evaluating The Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: * For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) * For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine Secondary Objectives: * To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine * To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine * To assess the immunogenicity of tusamitamab ravtansine * To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination |
SANOFI | 2021-03-29 |
| 315 | A Phase 3 Study of The Efficacy, Safety and Pharmacokinetics of Ustekinumab As Open-label Intravenous Induction Treatment Followed By Randomized Double-blind Subcutaneous Ustekinumab Maintenance in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics \[PK\]) in pediatric participants with moderately to severely active UC. |
JANSSEN RESEARCH & DEVELOPMENT | 2021-03-17 |
| 316 | A Phase I/II Observer-blind, Randomized, Placebo-controlled, Multi-center Trial to Evaluate The Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Hong Kong/125/2017-like (H7N9) Virus Vaccine With AS03 Adjuvant System, Given As A Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Study to evaluate the safety and immunogenicity of H7N9 antigen in combination with full or half doses of AS03 adjuvant system in healthy adults. |
GLAXOSMITHKLINE | 2021-03-16 |
| 317 | Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used As Adjunctive Treatment in Pediatric Study Participants With Epilepsy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam. |
UCB BIOPHARMA SRL | 2021-03-11 |
| 318 | A Single-Arm, Open-Label, Dose Escalation Phase 1a Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CN201 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to provide a basis for further clinical development of CN201. |
YUQIN SONG; | 2021-03-04 |
| 319 | A Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Proof-of-Concept Clinical Study to Evaluate The Safety and Efficacy of JNJ-64304500 As Add-on Therapy to Standard of Care Biologic Therapy With Anti-Tumor Necrosis Factor Alpha or Anti-Interleukin 12/23 in Responder Not Remitter Participants With Active Crohn’s Disease Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in participants with active Crohn’s disease in response but not remission to SOC biologic therapy. |
JANSSEN RESEARCH & DEVELOPMENT | 2021-03-03 |
| 320 | A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-486, A Bispecific Antibody Targeting CD19 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a phase 1, open-label study evaluating the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of TNB-486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) who have received 2 or more prior lines of therapy. The study consists of 3 parts, a monotherapy dose escalation (Arm A), a monotherapy dose expansion in subjects with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL) (Arm B), … |
TENEOTWO | 2021-03-02 |
| 321 | A Phase 1/2 Study of JNJ-64007957, A Humanized BCMA * CD3 Bispecific Antibody in Japanese Patients With Relapsed or Refractory Multiple Myeloma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (RRMM) at the recommended Phase 2 dose (RP2D) identified in Study 64007957MMY1001 (NCT03145181) in Phase 1 part and to evaluate the efficacy of teclistamab at RP2D for Japanese participants in Phase 2 part. |
JANSSEN PHARMACEUTICAL K K | 2021-02-22 |
| 322 | Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of A Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection. |
CARE PHARMA SHANGHAI | 2021-02-22 |
| 323 | A Phase IV, Single-blind, Randomised, Controlled, Multi-country Study to Evaluate The Immunogenicity and Safety of GSK’s Infanrix Hexa (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV’s Vaxelis (DTaP5-HBV-IPV Hib), When Administered Intramuscularly According to A 2-, 4- and 12-month Schedule in Healthy Infants and Toddlers PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and immunogenicity of GSK’s combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV’s DTaP5-HBV-IPV-Hib vaccine administered to healthy infants and toddlers, between 6 and 12 weeks of age at the time of first vaccination, based on a 2-, 4-, and 12-months of age vaccination schedule. |
GLAXOSMITHKLINE | 2021-02-17 |
| 324 | A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy Vs. Nivolumab in Combination With Chemotherapy As First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC). |
BRISTOL MYERS SQUIBB | 2021-02-17 |
| 325 | CONNected Electronic Inhalers Asthma Control Trial 2 (CONNECT 2), A 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study of Standard of Care Treatment Versus The EMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group. The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, … |
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D | 2021-02-16 |
| 326 | A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy. |
BRISTOL MYERS SQUIBB | 2021-02-05 |
| 327 | An Open-Label Study to Evaluate The Long-Term Safety and Efficacy of Lanadelumab for Prevention Against Acute Attacks of Non-histaminergic Angioedema With Normal C1-Inhibitor (C1-INH) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (SC) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal C1-inhibitor who completed study SHP643-303 (NCT04206605). |
JOHN ANDERSON; | 2021-02-05 |
| 328 | A Phase 1, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate The Safety, Tolerability, and Immunogenicity of A Polyvalent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this phase 1, randomized, double-blind, active-comparator-controlled study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (pPCV) with that of PNEUMOVAX™ in healthy Japanese adults. |
MERCK SHARP & DOHME | 2021-02-04 |
| 329 | HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen. |
DAIICHI SANKYO | 2021-02-02 |
| 330 | A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, A Humanized GPRC5D X CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3). |
JANSSEN RESEARCH & DEVELOPMENT | 2021-02-01 |
| 331 | Maternal and Fetal Outcome With Metformin Therapy for Obese Pregnant Women A Randomized Control Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the role of metformin in pregnant women with obesity (BMI above 30) , on maternal and infant outcome. |
ANDREW IBRAM SAMY; | 2021-02-01 |
| 332 | Gaucher Disease During Infancy and Early Childhood and Experience With Enzyme Replacement Therapy (ERT) Using Velaglucerase Alfa (VPRIV): A Combined Retrospective and Prospective Cohort Study PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to learn if velaglucerase alfa (VPRIV) improves growth and symptoms in participants up to 5 years of age with Gaucher disease. Symptoms will be checked with blood tests. This study is about collecting data available in the participant’s medical record as well as data from each participant’s ongoing treatment. No study medicines will be provided to participants in this study. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. When the participants start the study, … |
OZLEM GOKER-ALPAN; | 2021-01-08 |
| 333 | A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy As First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of participants with advanced, metastatic, or recurrent unresectable intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene rearrangements |
TAIHO ONCOLOGY | 2021-01-06 |
| 334 | A Phase 4 Study of Nusinersen (BIIB058) Among Patients With Spinal Muscular Atrophy Who Received Onasemnogene Abeparvovec PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, researchers will learn more about the use of nusinersen (BIIB058) in participants with spinal muscular atrophy (SMA). This study will focus on children under the age of 3 who were previously treated with the gene therapy onasemnogene abeparvovec but are still facing health challenges related to their disease. The main goal of the study is to learn about the effect nusinersen has on muscle and movement ability (motor function). The main question researchers want to answer is: – … |
BIOGEN | 2021-01-04 |
| 335 | Effect of Zamzam Water on Amniotic Fluid Index, in Oligohydramnios : A Randomized Controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The aim of this study is to evaluate the efficacy of drinking zamzam water versus tap water in increasing the AF index in women with oligohydramnios. |
HANY FAROUK; | 2021-01-01 |
| 336 | Protocol for A Cohort Diagnostic Accuracy Study to Develop Prediction of Renal Parenchymal Damage and to Evaluate Accuracy of Renal Function in Congenital Anomalies of The Kidney and Urinary Tract (CAKUT) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To establish the prediction of the renal damage and renal development deficiency in congenital anomalies of kidney and urinary tract (CAKUT), a diagnostic accuracy study on MRI-DWI combined with urinary microprotein detection is to carried out comparing with DMSA scan as the golden standard for renal damage. |
CHILDREN’S HOSPITAL OF FUDAN UNIVERSITY | 2021-01-01 |
| 337 | A Multicenter, Open-Label, Follow-Up Study to Assess The Long-Term Use of Oral Lacosamide in Study Participants Who Completed EP0034 or SP848 and Received Lacosamide Treatment PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the long-term use of lacosamide oral solution dosed at 2 mg/kg/day to 12 mg/kg/day when administered to pediatric study participants with epilepsy who have completed NCT01964560 (EP0034) or NCT00938912 (SP848). |
UCB BIOPHARMA SRL | 2020-12-28 |
| 338 | A Prospective, Multicenter, Long-Term Study to Assess The Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Prurigo Nodularis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of this study is to assess the long-term safety of nemolizumab (CD14152) in participants with prurigo nodularis (PN). |
GALDERMA R&D | 2020-12-15 |
| 339 | A Phase 1b/2 Dose Escalation and Expansion Study of The Combination of The Bispecific T Cell Redirection Antibodies Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to identify the recommended Phase 2 regimen(s) (RP2R\[s\]) and schedule for the study treatment (Part 1), to characterize the safety of the RP2R(s) for the study treatment (Part 2) and to evaluate the anticancer activity of talquetamab + teclistamab in participants with relapsed or refractory multiple myeloma and extramedullary disease (EMD) (Part 3). |
JANSSEN RESEARCH & DEVELOPMENT | 2020-12-15 |
| 340 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess The Efficacy and Safety of 400 Mg Twice A Day Oral Ladarixin in Patients With New-onset Type 1 Diabetes and Preserved Beta-cell Function at Baseline PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The objectives of this clinical trial are: – to evaluate whether a 12 month treatment with ladarixin is effective to improve glycemic control in newly diagnosed T1D adult patients with preserved beta-cell function. – to evaluate the safety of ladarixin in the specific clinical setting |
DOMPÉ FARMACEUTICI S P A | 2020-12-14 |
| 341 | The Association Between Niacin Deficiency and Birth Defects: A Case-control Study PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: This prospective case-control study aims to examine the effects of blood vitamin B levels in first-trimester pregnant women on the pregnancy outcomes |
HONGJUN SHI; | 2020-12-01 |
| 342 | A Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate The Efficacy, Immunogenicity and Safety of The 9vHPV Vaccine in Japanese Males, 16 to 26 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus [9vHPV] vaccine) in preventing HPV-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo. |
MERCK SHARP & DOHME | 2020-11-30 |
| 343 | A Phase I/IIA, Randomized, Placebo-Controlled, Single-Ascending Dose (Part A, Participant- and Investigator-Blind) and Repeated-Dose (Part B, Participant-, Investigator-, and Sponsor-Blind) Study to Investigate The Safety, Pharmacokinetics, and Efficacy of UCB9741 in Healthy Study Participants (Part A) and in Study Participants With Moderate-to-Severe Atopic Dermatitis (Part B) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to investigate the safety and tolerability of single-ascending doses of UCB9741 administered by intravenous infusion or subcutaneous injection to healthy study participants and following repeat dosing at a single dose level in study participants with atopic dermatitis. Furthermore, the clinical efficacy outcome in study participants with atopic dermatitis after administration of UCB9741 by intravenous infusion will be investigated. |
UCB BIOPHARMA SRL | 2020-11-27 |
| 344 | A Prospective, Multi-centric, Open-label, Single-arm, Phase 4 Study to Evaluate The Safety and Efficacy of Canagliflozin + Metformin Hydrochloride IR Fixed-dose Combination As An Adjunct to Diet and Exercise to Improve Glycemic Control in Indian Adult Patients With Type 2 Diabetes Mellitus When Treatment With Both Canagliflozin and Metformin Is Appropriate PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination. |
JOHNSON & JOHNSON PRIVATE | 2020-11-25 |
| 345 | Industry Alliance Platform Trial to Assess The Efficacy and Safety of Multiple Candidate Agents for The Treatment of COVID-19 in Hospitalized Patients PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the time to confirmed clinical recovery in participants hospitalized with COVID-19. Candidate agents will be evaluated frequently for efficacy and safety, with candidate agents being added to and/or removed from the study on an ongoing basis, depending on the results of their evaluation. |
AMGEN | 2020-11-24 |
| 346 | A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of A Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants Up to 6 Months of Age PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study also evaluated the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), … |
GLAXOSMITHKLINE | 2020-11-20 |
| 347 | A Randomized, Phase 2, Double-blind Study to Evaluate The Efficacy of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Metastatic Non-Squamous Non-Small Cell Lung Cancer PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), … |
GLAXOSMITHKLINE | 2020-11-19 |
| 348 | A Multicenter, Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection When Used in Routine Medical Practice in China PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the safety of nusinersen sodium injection in the postmarketing setting in China.The secondary objectives are to collect data on the efficacy and the pharmacokinetics of nusinersen sodium injection in the post-marketing setting in China. |
BIOGEN | 2020-11-18 |
| 349 | Feasibility Study of CoolSculpting Effects on Cellulite Appearance PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting. |
ZELTIQ AESTHETICS | 2020-11-13 |
| 350 | A Randomized, Controlled, Multicenter, Open-label Study to Investigate The Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed By PSMA-PET With An Observational Cohort PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone. |
JANSSEN PHARMACEUTICA N V BELGIUM | 2020-11-12 |
| 351 | Immunogenicity and Safety of A High-Dose Quadrivalent Influenza Vaccine in Subjects 65 Years of Age and Older in Taiwan PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: Immunogenicity: To describe the immune response induced by high-dose quadrivalent influenza vaccine (QIV-HD) and AdimFlu-S (QIS) by hemagglutinin inhibition (HAI) measurement method in all participants. Safety: To describe the safety profile of all participants in each study groups. |
SANOFI PASTEUR A SANOFI COMPANY | 2020-11-10 |
| 352 | Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Teduglutide (Revestive®) in Adult and Pediatric Patients With Short Bowel Syndrome in Argentina PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®). This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant’s medical records will be reviewed and collected for this study. Participants do not need to visit their doctor in addition to their normal visits. |
RAUL BOZZO; | 2020-11-05 |
| 353 | A Phase 1b, Randomized, Double-blind, Single and Repeat Dosing Study to Evaluate The Safety, Pharmacokinetics, and Pharmacodynamics of Lanadelumab When Added to Standard-of-Care in Subjects Hospitalized With COVID-19 Pneumonia Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety, pharmacokinetic and pharmacodynamics of lanadelumab administered by intravenous (IV) infusion when added to standard-of-care (SoC) in adults hospitalized with COVID-19 pneumonia. |
SHIRE | 2020-10-31 |
| 354 | A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study of The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB107 in Healthy Adult Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants. |
BIOGEN | 2020-10-30 |
| 355 | CONNected Electronic Inhalers Asthma Control Trial 1 (CONNECT 1), A 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate The Effectiveness of The Albuterol EMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma. The study will consist of a screening visit, a 12-week open-label treatment period, … |
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D | 2020-10-26 |
| 356 | A Phase I, Randomized Study of The Safety and Efficacy of Intravenous Delivery of Lung Spheroid Stem Cells (LSCs) in Patients With Idiopathic Pulmonary Fibrosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Purpose: To demonstrate the safety and efficacy of autologous Lung Spheroid Stem Cells (LSCs) administered by intravenous infusion in patients with idiopathic pulmonary fibrosis Progressive Fibrotic Interstitial Lung Disease. Participants: Patients with Idiopathic Pulmonary Fibrosis (IPF) and Progressive Fibrotic Interstitial Lung Disease Procedures (methods): 24 patients previously diagnosed with idiopathic pulmonary fibrosis or Progressive Fibrotic Interstitial Lung Disease meeting all inclusion/exclusion criteria will be evaluated at baseline. LSCs will be grown from autologous trans-bronchial pulmonary biopsy specimens. The first group, … |
LEONARD LOBO; | 2020-10-22 |
| 357 | Immunogenicity and Safety of High-Dose Quadrivalent Influenza Vaccine (SP0178) Administered By Intramuscular Route Versus Standard-Dose Quadrivalent Influenza Vaccine By Subcutaneous Route in Subjects 60 Years of Age and Older in Japan PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all participants. Secondary Objective: – To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method in all participants. – To describe the safety profile of all participants in each study group. |
SANOFI PASTEUR A SANOFI COMPANY | 2020-10-21 |
| 358 | Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Dapirolizumab Pegol (BIIB133) in Healthy Japanese and Caucasian Study Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants. The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- … |
AMINA HAGGAG; | 2020-10-14 |
| 359 | Clinical Study of Stereotactic Transplantation of Human Amniotic Epithelial Stem Cells (hAESCs) in The Treatment of Parkinson’s Disease (PD) Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and efficacy of stereotactic transplantation of hAESCs for Parkinson’s disease. |
WU JINGWEN; | 2020-10-08 |
| 360 | A Phase 3 Open-label Randomized Clinical Trial to Evaluate The Safety, Reactogenicity and Immunogenicity of A 2-dose Ebola Vaccine Regimen of Ad26.ZEBOV Followed By MVA-BN-Filo in Healthy Pregnant Women PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is: a) to assess adverse maternal/fetal outcomes in pregnant women randomized to receive the 2- dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \[Group A\]) and in control women (unvaccinated pregnant women \[Group B\]); and b) to assess adverse neonatal/infant outcomes in neonates/infants born to women randomized to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo \[Group A\]) and in neonates/infants born to control women (unvaccinated during pregnancy \[Group B\]). |
JANSSEN VACCINES & PREVENTION B V | 2020-10-05 |
| 361 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS) |
APELLIS PHARMACEUTICALS | 2020-09-30 |
| 362 | A Post Approval Commitment Study to Evaluate The Efficacy, Safety, and Pharmacokinetics of KOVALTRY in Chinese Children, Adolescents /Adults With Severe Hemophilia A PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The goal of this study is to gather more information on safety and efficacy of Kovaltry for the prevention and treatment of bleeds in Chinese children, adolescents/adults with severe hemophilia A. In addition, pharmacokinetic parameters of Kovaltry will be assessed in a subset of patients. |
BAYER | 2020-09-22 |
| 363 | A Phase 1, Open-Label, Single Ascending Dose Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of TEPEZZA Subcutaneous Administration in Healthy Adult Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to assess the pharmacokinetics (PK) parameters of a single subcutaneous (SubQ) infusion of TEPEZZA with and without ENHANZE™ Drug Product (EDP) at 2 dose levels in healthy adult participants. |
AMGEN | 2020-09-22 |
| 364 | A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate The Effect of Food on The Pharmacokinetics of Mirabegron in Healthy Chinese Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants. This study also evaluated the safety and tolerability of single oral doses of mirabegron in healthy Chinese male and female participants. |
ASTELLAS PHARMA CHINA | 2020-09-21 |
| 365 | A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, A Humanized BCMA X CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D). |
JANSSEN RESEARCH & DEVELOPMENT | 2020-09-17 |
| 366 | A Phase 1 Multiple Ascending Intradermal Dose Study to Assess The Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM). This study will also evaluate the effect of multiple ascending intradermal doses of ASP2390 on HDM-specific immunoglobulin G subclass 4 (IgG4) levels in adult male and female participants allergic to HDM. |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2020-09-09 |
| 367 | Prospective Study on The Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This prospective cohort study aims to assess the utility of a panel of molecular biomarkers for predicting the risk of relapse of Barrett’s Oesophagus after endoscopic treatment of early oesophageal neoplasia with RadioFrequency Ablation (RFA). Patients who received endoscopic treatment of early oesophageal neoplasia with RFA and achieved endoscopic remission will be recruited. During the surveillance visits patients will receive a Cytosponge test followed by an endoscopy with Narrow Band Imaging (NBI) magnification and biopsies. Patients will receive an endoscopy every 6 months and Cytosponge every 12 months for at least 2 years. Molecular biomarkers including a methylation panel on DNA and immunohistochemical markers on formalin fixed paraffin embedded samples. After 2 years of intensive endoscopic follow up, patients will be prospectively tracked for up to 3 years. The investigators will also evaluate: – The risk of progression to dysplasia or oesophageal intestinal metaplasia (IM) in patients with IM at the GOJ post RFA in the absence of retreatment – the diagnostic accuracy of NBI for IM/dysplasia at the GOJ . |
MASSIMILIANO DI PIETRO; | 2020-09-01 |
| 368 | A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the efficacy and safety of fluzoparil combined with temozolomide in patients with recurrent glioblastoma. |
JINMING YU; | 2020-09-01 |
| 369 | Synergistic Real-world Study and Evidence-based Medicine Evaluation of Elemene Combined With Tyrosine Kinase Inhibitors（TKIs）in The Treatment of Advanced Non-small Cell Lung Cancer（NSCLC）：Retrospective Study PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a nationwide, multicenter and retrospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer. |
TIAN XIE; | 2020-08-28 |
| 370 | A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess The Safety and Immunogenicity of GSK’s Meningococcal Group B Vaccine When Administered Concomitantly With GSK’s Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age. |
GLAXOSMITHKLINE | 2020-08-25 |
| 371 | A Phase 3 Randomized, Open-Label, Clinical Trial to Study The Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group. |
MERCK SHARP & DOHME | 2020-08-25 |
| 372 | A Phase 1b/2 Study of TAK-981 Plus Pembrolizumab to Evaluate The Safety, Tolerability, and Antitumor Activity of The Combination in Patients With Select Advanced or Metastatic Solid Tumors PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: TAK-981 is being tested in combination with pembrolizumab to treat participants who have select advanced or metastatic solid tumors. The study aims are to evaluate the safety, tolerability, and preliminary efficacy of TAK-981 in combination with pembrolizumab. Participants will be on this combination treatment for 21-day cycles. They will continue with this treatment for up to 24 months or until participants meet any discontinuation criteria. |
TAKEDA | 2020-08-17 |
| 373 | A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK’s Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effectiveness of 2 doses or 3 doses of GSK’s licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK’s investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety will also be evaluated in the study. |
GLAXOSMITHKLINE | 2020-08-14 |
| 374 | A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) at 2-dose levels, as 2-dose schedule in healthy participants aged greater than or equal to 20 to less than or equal to 55 years and greater than or equal to 65 years in good health with or without stable underlying conditions. |
JANSSEN PHARMACEUTICAL K K | 2020-08-11 |
| 375 | A Phase 2, Multicenter, Non-Randomized, Open-Label Study of RVT-1401 for The Treatment of Patients With Warm Autoimmune Hemolytic Anemia Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia. |
IMMUNOVANT SCIENCES | 2020-08-11 |
| 376 | A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate The Pharmacokinetics, Safety, and Tolerability of A Single Oral Dose of Maribavir Administered in Healthy Japanese Subjects Compared With Matched, Healthy, Non-Hispanic, Caucasian Subjects and to Assess Dose-Proportionality of 3 Doses of Maribavir in The Japanese Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to compare the pharmacokinetics (PK), safety, and tolerability of maribavir administered as a single oral dose in healthy, adult participants of Japanese descent and matched, healthy, adult, non-Hispanic, Caucasian participants. In addition, this study will assess the dose-proportionality of PK of maribavir in healthy, adult participants of Japanese descent. |
SHIRE | 2020-08-07 |
| 377 | A Multicenter, Open-Label Phase 1/2 Trial Evaluating The Safety, Tolerability, and Efficacy of MORAb-202, A Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin. |
EISAI | 2020-08-06 |
| 378 | Open-Label Extension of The HOPE-2 Duchenne Muscular Dystrophy Trial PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This Phase 2, multi-center, open-label extension trial will provide deramiocel (CAP-1002) to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up. The trial will explore the safety and efficacy of twenty intravenous administrations of deramiocel, each separated by three months. Subjects will undergo a targeted screening during a 30-day screening period, eligible subjects will then undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of deramiocel. Subjects will complete trial assessments at Screening; Day 1; Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, … |
CRAIG MCDONALD; | 2020-08-05 |
| 379 | A Phase 2, Open-Label, Single-Arm Study to Evaluate The Safety and Efficacy of Niraparib in Patients With Advanced and Relapsed Ovarian Cancer After 3 or 4 Previous Chemotherapies PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values. |
RUTIE YIN; | 2020-08-04 |
| 380 | Phase I Study of The Safety and Pharmacokinetics of Human Convalescent Plasma in High Risk Children Exposed or Infected With SARS-CoV-2 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will provide access to investigational anti-SARS-CoV-2 human convalescent plasma for pediatric patients with underlying medical conditions (cardiovascular disease, lung disease, immunosuppression) who are either infected with SARS-CoV-2 or who have had a high-risk exposure. Study participants will be transfused once with compatible convalescent plasma obtained from an individual who has recovered from documented infection with SARS-CoV-2. Safety information and pharmacokinetic data will be collected. |
JAIME G. DEVILLE; | 2020-08-01 |
| 381 | A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate A Range of Dose Levels of An Ad26.RSV.preF-based Vaccine in Adults Aged 60 Years and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to explore the dose-response relationship of immune responses induced by different dose levels of an Ad26.RSV.preF based vaccine (Cohort 1) and to assess the safety and reactogenicity of different dose levels of the Ad26.RSV.preF-based vaccine (Cohorts 2 and 3). |
JANSSEN VACCINES & PREVENTION B V | 2020-07-16 |
| 382 | Evaluation of Long-term Safety of ADYNOVI/ADYNOVATE (Antihaemophilic Factor [Recombinant] PEGylated, Rurioctocog Alfa Pegol) in Patients With Haemophilia A – An ADYNOVI/ADYNOVATE Post-Authorisation Safety Study (PASS) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting. |
BAXALTA NOW PART OF SHIRE | 2020-07-09 |
| 383 | A Phase I, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess The Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will be conducted. |
MARTIN KANKAM; | 2020-07-06 |
| 384 | A Phase 1, Randomized, Placebo-Controlled Study to Evaluate The Tolerability, Safety, Pharmacokinetics, and Immunogenicity of LY3832479 Given As A Single Intravenous Dose in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center. |
ELI LILLY | 2020-06-19 |
| 385 | Phase 1/2a, First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BNT411 As A Monotherapy in Patients With Solid Tumors and in Combination With Atezolizumab, Carboplatin and Etoposide in Patients With Chemotherapy-naïve Extensive-stage Small Cell Lung Cancer (ES-SCLC) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This first-in-human (FIH) trial aimed to establish a safe dose of BNT411 as a monotherapy and in combination with atezolizumab, carboplatin and etoposide. BNT411 is a toll-like receptor 7 (TLR7) agonist which is expected to mount broad innate and adaptive immune reactions, especially in combination with cytotoxic therapies and immune checkpoint inhibitors. |
BIONTECH SE | 2020-06-19 |
| 386 | Clinical Study to Investigate The Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With Von Willebrand Disease (VWD) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a prospective, non-controlled, international, multi-center phase 3 study investigating the efficacy and safety of Wilate in previously treated adult patients with VWD, to obtain additional data on the safety and efficacy of Wilate in previously treated patients with VWD undergoing regular prophylaxis. |
OCTAPHARMA | 2020-06-18 |
| 387 | A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCY PF:8 Related Papers Related Patents Related Grants Related Experts View Highlight: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants. |
PFIZER | 2020-06-17 |
| 388 | A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate The Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone. Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), … |
LUIS ABRISHAMIAN; | 2020-06-17 |
| 389 | A Cross-over, Open-label, Randomized Study Evaluating The Safety and Immunogenicity of The Inactivated Rabies Vaccine RABIVAX-S on Healthy Vietnamese Volunteers With 3 Doses of Pre-exposure Prophylaxis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Randomized, open-label, prospective, before-and-after comparison study in the same group. Subjects suitable for the study will be randomly assigned at a ratio of 1:1 (block 4) to use the study vaccine by one of two routes of administration: Intramuscular or Intramuscular. Previously-unvaccinated subjects receive three injections of vaccine on day 0, 7 and 21-28. The aim of the study is to evaluate the safety and immunogenicity of the inactivated rabies vaccine RABIVAX-S administered intramuscularly and intradermally according to a 3-dose regimen in healthy volunteers. |
PHAM NGOC HUNG; | 2020-06-13 |
| 390 | A Phase II Study of Intraperitoneal and Intravenous Paclitaxel Chemotherapy With Oral Capecitabine for Gastric Adenocarcinoma With Peritoneal Carcinomatosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Background: Three-fourths of people diagnosed with gastric cancer will die from it. Researchers want to see if giving cancer drugs in a new way can help people live longer and delay the time it takes for the cancer to grow. Objective: To find a better way to treat advanced stomach cancer. Eligibility: People ages 18 and older with stomach cancer that has spread throughout their belly. Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests Scans Cancer sample: If they do not have one, … |
ANDREW BLAKELY; | 2020-06-09 |
| 391 | Effect of Nicorandil, Diltiazem or Isosorbide Mononitrate for Oral Antispastic Therapy After Coronary Artery Bypass Grafting Using Radial Artery Grafts – A Pilot Randomized Controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The Pilot study will be a single-center, randomized, open-label, active-controlled trial. After CABG surgery using Radial Artery Grafts (RA-CABG) and signing the informed consent, all patients will be screened according to the inclusion and exclusion criteria. Estimated 150 patients will be enrolled and randomized by ratio 1:1:1 to receive either Nicorandil (5mg tid po) or Diltiazem (180mg qd po) or Isosorbide Mononitrate (50mg qd po). Follow-up visits will be conducted at Week 1, 4, 12, … |
QIANG ZHAO; | 2020-06-02 |
| 392 | Specified Drug Use-Results Survey of EVRENZO® Tablets: Non-interventional, Prospective Drug Use-results Survey in The Realworld Use of EVRENZO® Tablets (Roxadustat) in Patients With Renal Anemia PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and efficacy, including the incidence of thromboembolism, in renal anemia patients treated with roxadustat (EVRENZO® Tablets) in actual clinical settings. |
ASTELLAS PHARMA | 2020-06-01 |
| 393 | A Randomized, Double-blind, Placebo-controlled, Study Evaluating The Efficacy and Safety of Otilimab IV in Patients With Severe Pulmonary COVID-19 Related Disease PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: OSCAR (Otilimab in Severe COVID-19 Related Disease) is a multi-center, double-blind, randomized, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study is being conducted in 2 parts (Part 1 and Part 2). Otilimab is a human monoclonal anti-granulocyte macrophage colony stimulating factor (GM-CSF) antibody that has not previously been tested in participants with severe pulmonary COVID-19 related disease in Part 1. The aim of this study is to evaluate the benefit-risk of a single infusion of otilimab in the treatment of hospitalized participants with severe COVID-19 related pulmonary disease with new onset hypoxia requiring significant oxygen support or requiring early invasive mechanical ventilation (less than or equal to [<=] 48 hours before dosing). Participants will be randomized to receive a single intravenous (IV) infusion of otilimab or placebo, in addition to standard of care. |
GLAXOSMITHKLINE | 2020-05-28 |
| 394 | A Randomized, Double-Blinded, Vehicle-Controlled, Multicenter, Parallel-Group Study of APL-9 in Mild to Moderate Acute Respiratory Distress Syndrome Due to COVID-19 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and effectiveness of APL-9 in adults with mild to moderate ARDS (acute respiratory distress syndrome) caused by COVID-19 who are hospitalized and require supplemental oxygen therapy with or without mechanical ventilation. It is thought that COVID-19 activates the complement system, part of the immune system that responds to infection or tissue damage, and increases inflammation in the lungs. APL-9 has been designed to inhibit or block activation of part of the complement pathway, and potentially reduce inflammation in the lungs. Part 1 of the study is open-label to evaluate safety; … |
APELLIS PHARMACEUTICALS | 2020-05-28 |
| 395 | A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection into a vein to participants hospitalized with COVID-19. Blood tests will be done to check how much LY3819253 is in the bloodstream and how long the body takes to eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the hospital or the home. |
ELI LILLY | 2020-05-28 |
| 396 | Immunogenicity and Safety of A Single Dose of An Investigational Quadrivalent Meningococcal Conjugate Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine). Secondary Objective: Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, … |
SANOFI | 2020-05-22 |
| 397 | Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women can reduce adverse pregnancy outcomes. Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group. |
WEIMING TANG; | 2020-05-21 |
| 398 | Real-world Study on Afatinib As First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer (NSCLC) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment. |
BOEHRINGER INGELHEIM | 2020-05-20 |
| 399 | A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate The Safety, Reactogenicity and Immunogenicity of Single Vaccination of An Ad26.RSV.preF-based Regimen in Japanese Adults Aged 60 Years and Older PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years. |
JANSSEN PHARMACEUTICAL K K | 2020-05-15 |
| 400 | An Extension Study to Assess The Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults With C9ORF72-Associated Amyotrophic Lateral Sclerosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective is to evaluate the long-term safety and tolerability of BIIB078 in participants with chromosome 9 open reading frame 72-amyotrophic lateral sclerosis (C9ORF72-ALS). The secondary objective is to evaluate the pharmacokinectic (PK) of BIIB078 in participants with C9ORF72-ALS. |
BIOGEN | 2020-04-28 |
| 401 | Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19. |
JANSSEN PHARMACEUTICA N V BELGIUM | 2020-04-24 |
| 402 | A Phase 2 Randomized Single-Blind Study to Evaluate The Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo. The study had 2 arms and evaluated selinexor 20 mg + standard of care (SoC) and placebo + SoC. As the treatment for COVID-19 is rapidly evolving, the SoC varied over time and across regions of the world. |
KARYOPHARM THERAPEUTICS | 2020-04-17 |
| 403 | Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children’s Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); … |
JOHN DAY; | 2020-03-26 |
| 404 | A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate The Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-acetyl-cysteine) After Subcutaneous Administration in Healthy Volunteers Related Papers Related Patents Related Grants Related Experts View Highlight: A clinical study to measure the Safety, Tolerability, and Pharmacokinetics of OP-101 After Subcutaneous Administration in Healthy Volunteers |
ORPHERIS | 2020-03-19 |
| 405 | CAEL101-203: A Phase 2, Open-label, Multicenter Dose Selection Study to Evaluate The Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab . |
ALEXION PHARMACEUTICALS | 2020-03-18 |
| 406 | A Randomized, Double-blind, Phase 1 Study to Evaluate The Safety, Reactogenicity, and Immunogenicity of Different Doses of VAC52416 (ExPEC10V) in Japanese Adults Aged 60 to 85 Years PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety and reactogenicity of different doses of extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age. |
JANSSEN PHARMACEUTICAL K K | 2020-03-13 |
| 407 | Noninvasive Fat Reduction With The CoolSculpting System PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction. |
ZELTIQ AESTHETICS | 2020-03-13 |
| 408 | An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9. |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2020-03-09 |
| 409 | A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study The Efficacy, Immunogenicity, and Safety of The 9vHPV Vaccine, A Multivalent L1 Virus-like Particle Vaccine, in The Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, … |
MERCK SHARP & DOHME | 2020-02-27 |
| 410 | An Open-Label Study to Evaluate The Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes Related Papers Related Patents Related Grants Related Experts View Highlight: This study was an extension of the NIH-sponsored At-Risk (TN-10) type 1 diabetes study (NCT 01030861). Teplizumab-treated and placebo-treated participants in the NIH trial who developed clinical type 1 diabetes after the conclusion of that trial, were eligible to enroll and receive teplizumab treatment within one year of diagnosis of clinical type 1 diabetes. |
PROVENTION BIO A SANOFI COMPANY | 2020-02-26 |
| 411 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess The Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn’s Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day [BID]) versus placebo, as add-on therapy in participants with Crohn’s disease who show symptoms of active inflammation despite being on ongoing treatment. |
OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION | 2020-02-25 |
| 412 | An Open-Label, Randomized, Single-Dose, 2-Part Crossover Study in Healthy Study Participants to Evaluate The Relative Bioavailability of 4 Padsevonil Product Variants and The Effect of Food on Padsevonil Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study in Part 1, is to evaluate (under fasted conditions) the plasma pharmacokinetics (PK) of padsevonil (PSL) using 4 PSL product variants against a PSL reference tablet and in Part 2, to evaluate the PK of PSL using a PSL reference tablet under fed and fasted conditions at 200 mg and 400 mg. |
UCB BIOPHARMA SRL | 2020-02-24 |
| 413 | A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for The Treatment of Subjects With Multiple Myeloma PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations. |
JANSSEN RESEARCH & DEVELOPMENT | 2020-02-21 |
| 414 | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate The Immunogenicity, Safety, Reactogenicity, and Consistency of A Heterologous 2-dose Vaccine Regimen Using 3 Consecutive Lots of Ad26.ZEBOV and MVA-BN®-Filo in Adult Participants PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate that the paired 2-dose vaccine regimens from 3 consecutively manufactured lots of Adenovirus serotype 26 encoding the Ebola virus Mayinga glycoprotein (Ad26.ZEBOV) as Dose 1 and 3 consecutively manufactured lots of Modified Vaccinia Ankara Bavarian Nordic vector encoding multiple filovirus proteins (MVA-BN-Filo) including the ebola virus mayinga glycoprotein as Dose 2, administered at a 56-day interval, induce an equivalent humoral immune response. |
JANSSEN VACCINES & PREVENTION B V | 2020-02-18 |
| 415 | An Open-Label, Single-Center, Randomized, Parallel-Group, Single-Dose Bioequivalence Study of Bimekizumab Given As 1x2mL or 2x1mL Subcutaneous Injection in Healthy Study Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to compare the pharmacokinetics (PK) of bimekizumab when administered subcutaneously (sc) as 1×2 mL versus 2×1 mL, using a bimekizumab-safety syringe presentation or bimekizumab-auto-injector presentation, in healthy study participants. |
UCB BIOPHARMA SRL | 2020-02-12 |
| 416 | A Long-term Follow-up Study of Patients in The Clinical Trials for Spinal Muscular Atrophy Receiving AVXS-101 PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment. |
NOVARTIS GENE THERAPIES | 2020-02-10 |
| 417 | Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate The Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy. |
UCB BIOPHARMA SRL | 2020-01-21 |
| 418 | Using Point of Care Ultrasound to Measure Perioperative Edema in Infants With Congenital Heart Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Babies can be born with heart problems and sometimes need a heart surgery to fix the heart problem. Heart surgery can cause swelling from the build-up of extra fluid. Swelling can make it harder for babies to breath and has to be treated with medicine called diuretics. Swelling is hard to measure in babies, … |
JESSICA PERSSON; | 2020-01-13 |
| 419 | The Effects of Maternal Exposure to Air Pollution During Pregnancy on Adverse Pregnancy Outcomes Mediated By Inflammatory Cytokine and Hormone PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This research evaluates the effects of maternal exposure to air pollution during pregnancy on adverse pregnancy outcomes, the general demographic information, the level of maternal exposure to air pollution, pregnancy-related information, the occurrence of adverse pregnancy outcomes, and serum indicators of pregnant women during pregnancy are collected. Finally, the research explores that whether the inflammatory cytokine and hormone can mediate the occurrence of adverse pregnancy outcomes under the maternal exposure to air pollution during pregnancy. |
FIRST AFFILIATED HOSPITAL XI’AN JIAOTONG UNIVERSITY | 2020-01-01 |
| 420 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Mechanistic Insight and Dosage Optimization Study of The Efficacy and Safety of VIB4920 in Patients With Rheumatoid Arthritis (RA) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of VIB4920 (formerly MEDI4920) in adult participants with rheumatoid arthritis (RA). |
VIELA BIO ACQUIRED BY HORIZON THERAPEUTICS | 2019-12-09 |
| 421 | Comparison of Regular Trigger Timing and Two Days Delay of Trigger in Ovarian Stimulations By GnRH Antagonist Protocol in in Vitro Fertilization PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The use of antagonist ovulation stimulation program is increasing year by year, because of its convenience, flexibility, and prevention effect of ovarian hyperstimulation syndrome. However, many researchers and clinicians believe that the clinical outcomes of antagonist regimens are worse than those of classical long-term regimens. Studies showed that the reasons for that maybe antagonist protocol results in poor effect on oocytes maturation or endometrial receptivity. At present, the trigger time of antagonist regimen is more than three follicles with diameters of ≥17 mm, … |
LI RONG; | 2019-12-01 |
| 422 | A Phase 1 Multi-Center Study to Measure The Pharmacokinetics of Oral Omadacycline in Adult Subjects With Community-Acquired Bacterial Pneumonia (CABP) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the pharmacokinetics of an oral omadacycline dosing regimen in the treatment of adults with CABP. |
PARATEK PHARMACEUTICALS | 2019-11-28 |
| 423 | DOLOMITE NEAT ID Network Study: A Prospective, Multi-site Observational Study to Define The Safety and Effectiveness of Dolutegravir Use in HIV Positive Pregnant Women PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety and effectiveness of DTG use in HIV positive pregnant women. This is a 3-year multi-site prospective observational study. Approximately, 250 HIV positive pregnant women from potential European AIDS Treatment Network (NEAT ID) sites across Europe will be enrolled. The enrollment period will be over 2 years with a follow-up period of 1 year for outcomes. The data collected will be that obtained during routine standard of care assessments; and the subjects will not undergo any interventional study procedures. |
MARTA GUTIÉRREZ; | 2019-11-18 |
| 424 | LORA-PITA (REGISTERED) Intravenous Injection 2 Mg General Investigation PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan. |
PFIZER | 2019-11-18 |
| 425 | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2-Sequence Crossover Study to Explore Pharmacodynamic Effects of BIIB104 on Brain Circuitry Using BOLD Functional MRI and Arterial Spin Labeling in Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to explore the pharmacodynamic (PD) effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants. The secondary objectives of the study are to evaluate the safety and tolerability of BIIB104 in healthy participants; To further explore the PD effects of BIIB104 on brain circuitry associated with emotional processing in healthy participants; To explore the PD effects of BIIB104 on brain circuitry associated with working memory in healthy participants using the N-Back; To explore the PD effects of BIIB104 on regional cerebral blood flow (CBF) in healthy participants; … |
BIOGEN | 2019-11-15 |
| 426 | A Phase 3, Follow-Up Trial to Evaluate Long-Term Safety and Antibody Persistence, and The Impact of A Booster Dose of A Tetravalent Dengue Vaccine Candidate in Healthy Adolescents and Adults in Areas Non-Endemic for Dengue PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States [US]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo. |
TAKEDA | 2019-11-12 |
| 427 | A Randomized, Open-label, Multiple-dose, Parallel Study to Compare The Pharmacokinetics and to Evaluate Drug-Drug Interaction of CG-651 in Healthy Volunteers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is randomized , open-label, multiple-dose, parallel study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of CG-651 in healthy volunteers. |
CRYSTALGENOMICS | 2019-11-11 |
| 428 | A Follow-up of A Phase 3 Study to Evaluate The Long-term Safety and Efficacy of Darvadstrocel in The Treatment of Complex Perianal Fistula in Subjects With Crohn’s Disease Who Have Participated in ADMIRE II Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The main aim is to follow-up on long term side effect and symptom improvement of Darvadstrocel in the treatment of complex perianal fistula in adults. Participants will not receive any drug in this study. |
TAKEDA | 2019-11-05 |
| 429 | A Phase 2a Randomized, Single-Center, Double-Blind, Placebo Controlled Study to Evaluate The Safety and Preliminary Efficacy of Oral IOWH032 Against Cholera Diarrhea in A Controlled Human Infection Model PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This trial was designed to assess safety and preliminary efficacy of oral doses of iOWH032 on diarrhea output and clinical symptoms after a cholera challenge in healthy adult participants. |
PATH | 2019-11-04 |
| 430 | The Efficacy and Safety of Lenalidomide With or Without Rituximab and Other Drugs in B-cell Non-Hodgkin Lymphomas: A Real-world Study PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Describe the treatment of B-cell non-Hodgkin lymphoma patients who receive lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs), and evaluate the efficacy and safety of lenalidomide single drug or lenalidomide combined with rituximab (with or without other drugs) in the real-world setting. |
ZHAO WEILI; | 2019-11-01 |
| 431 | Immunogenicity and Safety of A High-Dose Quadrivalent Influenza Vaccine Administered By The Intramuscular Route in Subjects 60 Years of Age and Older PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: To demonstrate that high-dose quadrivalent influenza vaccine (QIV-HD) induces an immune response that is superior to the responses induced by standard-dose quadrivalent influenza vaccine (QIV-SD) for all 4 virus strains 28 days post-vaccination in participants 60 to 64 years of age and in participants 65 years of age and older. Secondary Objective: – Immunogenicity: To further describe the immune response induced by QIV-HD and QIV-SD in all participants by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). – Safety: To describe the safety profile of all participants by age group, in pooled age groups, … |
SANOFI PASTEUR A SANOFI COMPANY | 2019-10-28 |
| 432 | An Open-label, Randomized, Parallel Group, Single Dose Study to Investigate The PK and Safety of Belimumab 200 Mg Intravenous and 200 Mg Subcutaneous Via Auto-injector in Chinese Healthy Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-label, randomized, parallel group, single dose study in healthy Chinese subjects. The purpose of this study is to characterize the pharmacokinetic profile and safety profile of 200 mg single dose of belimumab, administered either intravenously or subcutaneously via auto-injector. Each subject will be randomized in a 1:2 ratio to receive a single dose of either intravenous (IV) or subcutaneous (SC) administration of belimumab 200 mg. The total study duration will be approximately 13 weeks. |
GLAXOSMITHKLINE | 2019-10-28 |
| 433 | A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study. |
MERCK SHARP & DOHME | 2019-10-22 |
| 434 | A Controlled Human Infection Study of Influenza A/Bethesda/MM2/H1N1 Virus (A/California/04/2009/H1N1-like) in Healthy Subjects to Assess The Effect of Pre-Existing Immunity on Symptomatic Influenza Virus Infection PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a study of a reverse-engineered, Good Manufacturing Practice (GMP) grade, antiviral-sensitive, influenza A/Bethesda/MM2/H1N1 virus (A/California/04/2009/H1N1-like) infection to assess the effect of pre-existing immunity on clinical and immunological responses. Up to 80 healthy adult subjects will undergo intranasal inoculation with A/Bethesda/MM2/H1N1 virus, and their clinical manifestations, viral shedding and immunological responses will be characterized. The Primary Objective for this study is to evaluate the association of symptomatic Reverse Transcription-Polymerase Chain Reaction (RT-PCR)-positive influenza virus infection post-challenge and pre-existing Hemagglutinin Inhibition Test (HAI) antibody titers. |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2019-10-22 |
| 435 | A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of The Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (aMN) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory) |
HI BIO A BIOGEN COMPANY | 2019-10-15 |
| 436 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending, Multidose Study to Evaluate The Safety and Efficacy of Linaclotide in Pediatric Participants (Age 2 to 5 Years) With Functional Constipation PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation. |
ALLERGAN | 2019-10-14 |
| 437 | The Interplay of Microcirculation and Plasticity After Ischemic Stroke PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Reperfusion is the main goal of early medical interventions after stroke, such as thrombolysis and thrombectomy. Recanalization works only if applied early – the earlier the better, but with a statistical cutoff of 4.5 hours where risk of hemorrhage outweighs the benefit. Recently, … |
UNIVERSITY OF ZURICH | 2019-10-07 |
| 438 | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess The Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered BID for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants. |
BIOGEN | 2019-10-02 |
| 439 | The Pre-clinical Study of Genomic Sequencing for Birth Defects in Newborns PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: In China, birth defects can reach as high as 5.6%, about 900,000 new cases of birth defects are added each year, making it the second cause of death for infants, with a total death rate of 19.1%. At present, China implements the three-level prevention and control system for birth defects, which is performed before marriage, before birth, and during the neonatal period. Newborn screening is the last line of defense against birth defects. Early screening diagnosis and timely intervention are extremely important, … |
XIA YUNQIU; | 2019-10-01 |
| 440 | Knowledge and Follow-up of Vitamin B9 Supplementation Recommendations for Women in The Periconceptional Period to Prevent Neural Tube Closure Defects: A Study Conducted With Health Professionnals and Women Who Have Just Given Birth in Rennes CHU PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The study objective is to assess the knowledge and the follow-up of vitamin B9 supplementation recommendations for women in the periconceptional period to prevent neural tube closure defects. It will be conducted with health professionnals and women who have just given birth in Rennes CHU. This study aimes to assess men’s and women’s knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not, in order to target our future prevention campaign. This will allow comparing the results before and after the prevention campaign. |
EMMA BAJEUX; | 2019-09-23 |
| 441 | A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) As First-line Treatment of Biliary Tract Cancer PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Study consisted of an open-label, safety run-in part and a randomized, double-blind, placebo-controlled Phase 2/3 part. In the Phase 2/3 part, the study was evaluated whether bintrafusp alfa in combination with the current standard of care (SoC) (gemcitabine plus cisplatin) improves overall survival (OS) in chemotherapy and immunotherapy-naïve participants with locally advanced or metastatic Biliary Tract Cancer (BTC) compared to placebo, gemcitabine and cisplatin. |
EMD SERONO RESEARCH & DEVELOPMENT INSTITUTE | 2019-09-20 |
| 442 | Effect and Safety of Subcutaneous Semaglutide 2.4 Mg Once Weekly Compared to Liraglutide 3.0 Mg Once Daily on Weight Management in Subjects With Overweight or Obesity PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will look at participants’ body weight from the start to the end of the study. The study will last for about 1½ years. This is to compare the effect on body weight in people taking semaglutide once a week or people taking liraglutide once every day. Participants will either get semaglutide, … |
NOVO NORDISK | 2019-09-11 |
| 443 | Fertility Preservation With Ovarian Tissue Freezing PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to obtain ovarian tissue from female patients undergoing gonadotoxic treatments or gonadal ablating surgery, and that in consequence may see their future fertility impaired. Participants will be offered to preserve (freeze) and use ovarian tissue for the purpose of conceiving in the future. Although, 86 live births have been reported with ovarian tissue cryo-preservation and grafting, the procedure is still considered experimental. This research, will help us to learn and validate how to perform ovarian tissue cryo-preservation and thawing in the fertility preservation context. |
JULIO SAUMET-CHILITO; | 2019-09-10 |
| 444 | A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of A Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and A United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age. |
SEQIRUS | 2019-09-06 |
| 445 | Japan Post-Marketing Surveillance – Specified Drug Use-results Survey for Peficitinib to Assess Safety and Effectiveness in The Patients With Rheumatoid Arthritis PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: The objective of this study is to investigate the safety and effectiveness in routine clinical practice and actual clinical setting for all patients with rheumatoid arthritis (RA) treated with peficitinib. |
ASTELLAS PHARMA | 2019-09-02 |
| 446 | A Multi-center, Single-arm, Non-interventional Study to Describe The Safety of FIRMAGON® (Degarelix Acetate for Injection) in Chinese Patients With Prostate Cancer and Need Androgen Deprivation Therapy PF:6 Related Papers Related Patents Related Grants Related Experts View Highlight: To evaluate the safety profile of FIRMAGON (to fulfill the regulatory authority’s requirement of Intensive Drug Monitoring in Chinese patients with prostate cancer need androgen deprivation therapy [ADT] treated with FIRMAGON). Study Design This study is a multi-center, single-arm, non-interventional, … |
FERRING PHARMACEUTICALS | 2019-09-01 |
| 447 | Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this prospective cohort study is to evaluate the safety and effectiveness of enhanced recovery after surgery (ERAS) to perform routine thoracoscopic repair for elective esophageal atresia type C |
HE QIUMING; | 2019-09-01 |
| 448 | An Open-label, Rapid Initiation Study for Extended-Release Buprenorphine Subcutaneous Injection (SUBLOCADE) PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is to evaluate the safety and tolerability of initiating SUBLOCADE™ treatment following a shorter period of transmucosal (TM) buprenorphine treatment. |
HOWARD HASSMAN; | 2019-08-29 |
| 449 | A Randomized Double-blind, Placebo-controlled Study Evaluating The Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD). Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study. |
SANOFI | 2019-08-22 |
| 450 | A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess The Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson’s Disease PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson’s Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094.The study is open for PD patients with verified presence or absence of variations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic variant. |
BIOGEN | 2019-08-12 |
| 451 | A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Assess The Efficacy, Immunogenicity and Safety of An Ad26.RSV.preF-based Regimen in The Prevention of RT PCR-confirmed RSV-mediated Lower Respiratory Tract Disease in Adults Aged 65 Years and Older PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to demonstrate the efficacy of active study vaccine in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed respiratory syncytial virus (RSV)-mediated lower respiratory tract disease (LRTD), when compared to placebo. |
JANSSEN VACCINES & PREVENTION B V | 2019-08-01 |
| 452 | A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate The Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 And/or JNJ-56136379 for The Treatment of Chronic Hepatitis B Virus Infection PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA. |
JANSSEN SCIENCES IRELAND UC | 2019-08-01 |
| 453 | ASCEND GO-2: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study of RVT-1401 for The Treatment of Patients With Active, Moderate to Severe Graves’ Ophthalmopathy PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the current study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG |
IMMUNOVANT SCIENCES | 2019-07-23 |
| 454 | A Cohort Study to Evaluate The Long-term Safety and Immunogenicity of The Candidate Ebola Vaccines Ad26.ZEBOV and MVA-BN®-Filo in Adults and Children PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The VAC52150EBL3005 (EBOVAC-Salone Extension) is a cohort study evaluating the long-term safety and immunogenicity of the candidate Ebola vaccines Ad26.ZEBOV and MVA-BN®-Filo in participants who were exposed to these vaccines in the VAC52150EBL3001 trial (EBOVAC-Salone, ClinicalTrials.gov Identifier: NCT02509494). No investigational vaccine will be administered during this study. The study will consist of an enrolment visit, a number of study visits and an end-of-study visit. |
DEBORAH WATSON-JONES; | 2019-07-22 |
| 455 | A Phase 3, Randomized, Observer-Blind Study to Evaluate The Safety, Tolerability, Immunogenicity of Serum Institute of India’s 10-Valent Pneumococcal Conjugate Vaccine (PNEUMOSIL®) Administered in A 2+1 Schedule to Healthy Infants in The Gambia PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are to evaluate the immunogenicity (antibody response) and safety and tolerability of a 2-dose primary series and booster dose (2+1 schedule) of Pneumosil co-administered with routine pediatric vaccines in healthy infants in The Gambia. |
ED CLARKE; | 2019-07-18 |
| 456 | A Multicenter, Open-label Extension Study to Evaluate The Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period. |
GALAPAGOS NV | 2019-07-18 |
| 457 | A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed By A Non-Controlled Extension Treatment Period, to Assess The Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman’s last period. Hot flashes can interrupt a woman’s daily life. The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, … |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2019-07-11 |
| 458 | A Phase 3, Randomized, Placebo-controlled, 12-week Double-blind Study, Followed By A Non-Controlled Extension Treatment Period, to Assess The Efficacy and Safety of Fezolinetant in Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman’s last period. Hot flashes can interrupt a woman’s daily life. The study treatments are fezolinetant 30 mg (1 tablet of fezolinetant and 1 placebo tablet) once a day, … |
ASTELLAS PHARMA GLOBAL DEVELOPMENT | 2019-07-10 |
| 459 | Immunogenicity and Safety of A Purified Vero Rabies Vaccine – Serum Free in Comparison With Verorab® and Imovax® Rabies, in A Simulated Rabies Post-exposure Regimen in Healthy Adults in France PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: Primary Objective: To demonstrate that Purified Vero Rabies Vaccine – Serum Free Vaccine generation 2 (VRVg-2) was non-inferior to Verorab and Imovax Rabies vaccines when co-administered with human rabies immunoglobulin (HRIG), in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer greater than or equal to (>=) 0.5 international units per milliliter (IU/mL) at Day 28, i.e., 14 days after the fourth vaccine injection. Secondary Objective: – To describe the safety profile of VRVg-2 versus Verorab and Imovax Rabies vaccines when co-administered with HRIG, as well as that of VRVg-2, after each vaccine injection. – … |
SANOFI PASTEUR A SANOFI COMPANY | 2019-07-01 |
| 460 | Assessment of Intellectual Abilities for Subjects With Velopharyngeal Incompetence and Their Impact on Speech Intelligibility PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: To Assess effect of intelligence on speech production on subjects with velopharyngeal incompetence Search if there is any relation between congenital Velopharyngeal incompetence and decrease IQ of patients |
ASSIUT UNIVERSITY | 2019-07-01 |
| 461 | Missing Microbes in Infants Born By Caesarean Section: Antenatal Antibiotics and Mode of Delivery PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: General adult healthy pregnant females in total 400, as well as their infants will be recruited. It is expected 67% will be vaginally delivered and 33% will be C Section deliveries. It is expected that of these groups that 40% of these women will be treated with antibiotics during their pregnancy. All C Section women (including emergency C Section) will be treated with IV Cefazolin at the time of incision, in theatre, to prevent internal wound infection. Primary objective The effect of maternal antibiotic administration during pregnancy upon the development of the intestinal microbiota until the age of two years; … |
GENE DEMPSEY; | 2019-07-01 |
| 462 | Pan-EU Real-World Experience With Imraldi® PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of this study is to evaluate candidate predictors of persistence on adalimumab (Imraldi®) participants diagnosed with immune-mediated inflammatory disease in Europe (EU). The secondary objectives of this study are to describe participant clinical characteristics at baseline, utilization of Imraldi® over time, biologic drug effectiveness over time, participant satisfaction with biologic administration, routine laboratory values and clinical evaluation measurements over time, use of relevant concomitant medication use over time, immunogenicity of biosimilars and to summarize safety events. |
BIOGEN | 2019-06-30 |
| 463 | A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate The Safety, Tolerability, and Immunogenicity of Catch-up Vaccination Regimens of V114 in Healthy Infants, Children, and Adolescents (PNEU-PLAN) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is 1) to evaluate the safety and tolerability of V114 with respect to the proportion of participants with adverse events (AEs) and 2) to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following the last dose for each vaccination group. There is no formal hypothesis testing in this study. |
MERCK SHARP & DOHME | 2019-06-25 |
| 464 | A Phase 1, Placebo-controlled, Randomized, Parallel Group Study to Evaluate The Tolerability, Safety and Pharmacokinetics of A Topical Patch AB001 Following Single and Repeated Administration in Healthy Subjects PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The study evaluates the safety, tolerability and pharmacokinetics of single and repeated doses of topical AB001 patch and the bioavailability relative to the oral capsule and topical positive comparative patch. |
FRONTIER BIOTECHNOLOGIES | 2019-06-24 |
| 465 | A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With A KRAS Mutation PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily on Day 1-5 and Day 15-19 of each 28-day cycle, in combination with FOLFIRI + Bevacizumab, as second-line treatment in adult participants who have metastatic colorectal cancer with a KRAS mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab. |
CARDIFF ONCOLOGY | 2019-06-24 |
| 466 | A Phase I, Open-Label, Single-Dose Study to Evaluate The Safety and Efficacy of Hepatic Artery Injection of Autologous Human Bone Marrow-Derived Mesenchymal Stem Cells (Cellgram™) in Patients With Alcoholic Liver Cirrhosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is to evaluate the safety and efficacy of a single dose of Cellgram™ delivered via hepatic artery in patients with decompensated alcoholic liver cirrhosis. |
JUAN GALLEGOS-OROZCO; | 2019-06-20 |
| 467 | Randomized Phase I/II Study of The Safety and Immunogenicity of A Single Dose of The Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered As Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age. |
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES NIAID | 2019-06-20 |
| 468 | A Phase 3b, Open-label, Single-arm Study of The Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That Is Not Adequately Controlled By Topical Therapy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone. |
AMGEN | 2019-06-17 |
| 469 | A Multicenter, Open-label, Uncontrolled Clinical Trial to Confirm The Tolerability of OPC-61815 in Patients With Congestive Heart Failure Who Have Difficulty With or Are Incapable of Oral Intake PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To confirm the tolerability of intravenous administration of OPC-61815 at 8 or 16 mg once daily for a maximum of 5 days to CHF patients with volume overload despite having received diuretics (injection) other than vasopressin antagonists and who have difficulty with or are incapable of oral intake. |
OTSUKA PHARMACEUTICAL | 2019-06-17 |
| 470 | A Randomized, Observer-blind, First-in-Human Phase 1/2a Study to Evaluate The Safety, Reactogenicity and Immunogenicity of Three Different Doses of VAC52416 (ExPEC10V) in Adults Aged 60 to 85 Years in Stable Health PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of 3 different doses of ExPEC10V and to select the optimal dose for further clinical development (Cohort 1). Cohort 2 is aimed to expand the dataset supporting the short- and long-term safety and immunogenicity of the optimal dose of ExPEC10V, … |
JANSSEN RESEARCH & DEVELOPMENT | 2019-06-06 |
| 471 | Hearing Screening Outcomes of Two Screening Tests in Newborns of Gestational Diabetic and Non-diabetic Mothers: A Prospective, Controlled Study PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: In this study, the investigators have aimed to investigate whether GDM is a risk factor for hearing impairment in newborns. To the investigators knowledge, this study is the first prospective, controlled study on this subject. |
ESRA GULEN YILDIZ; | 2019-06-01 |
| 472 | The Use of Videos for Informed Consent for Prenatal Genetic Screening: A Randomized Controlled Trial PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: This is a randomized controlled trial of a low income and low health literacy population of pregnant women from a diverse racial and ethnic background to assess the effectiveness of a pre-visit educational video on prenatal genetic screening and testing options. |
KARLA LEAVITT; | 2019-05-30 |
| 473 | Efficacy and Safety of 72-hour Infusion of Prostacyclin (1 Nanogram(ng)/Kilogram(kg)/Minute(Min)) in Trauma Patients With Haemorrhagic Shock Induced Endotheliopathy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A multicenter, randomized (1:1, iloprost: placebo), placebo controlled, blinded, investigator-initiated phase 2b trial in trauma patients with haemorrhagic shock and shock induced endotheliopathy (SHINE), investigating the efficacy and safety of continuous intravenous administrating of iloprost (1 ng/kg/min) versus placebo for 72-hours, in a total of 220 patients. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in trauma patients with haemorrhagic shock (SHINE) suffering from organ failure caused by endothelial breakdown, ultimately improving survival. |
PÄR JOHANSSON; | 2019-05-22 |
| 474 | A Phase 2, Randomized, Placebo-controlled, Double-blind, Multiple Dose Study to Evaluate The Efficacy and Safety of ANB019 in Subjects With Palmoplantar Pustulosis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A study to evaluate the efficacy and safety, and pharmacokinetic (PK) profile of multiple doses of imsidolimab (ANB019) in adults with palmoplantar pustulosis (PPP) |
ANAPTYSBIO | 2019-05-20 |
| 475 | A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, A Bruton’s Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK). |
BIOGEN | 2019-05-13 |
| 476 | Iron Deficiency Anemia Among Chinese Pregnant Women (IRON WOMEN): A Multi-center Prospective Cohort Study PF:7 Related Papers Related Patents Related Grants Related Experts View Highlight: Iron deficiency anemia during pregnancy, which may lead to adverse pregnancy outcomes, was a serious health problem in China. Various iron supplements used in different regions of China, however, the effects have not been well investigated. The objective of this study is to investigate the diagnosis, treatment and prognosis of iron deficiency and iron deficiency anemia in Chinese pregnant women. |
SUN XIN; | 2019-05-10 |
| 477 | A Phase II, Randomized, Double-Blind, Placebo Controlled Dose Ranging Study to Assess The Effect of RPL554 Added on to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to investigate the dose response of RPL554 in patients with moderate to severe CHRONIC OBSTRUCTIVE PULMONARY DISEASE that are still symptomatic despite treatment with a stable background of tiotropium over 4 weeks of treatment. This study is intended to support optimal dose selection for a Phase III program evaluating RPL554 as an add-on treatment to standard of care therapy. |
GARY FERGUSON; | 2019-05-01 |
| 478 | Faculty Member at Hasan Kalyoncu University PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: ABSTRACT Objective: To test the effect of the Premature Infant Oral Motor Intervention (PIOMI) at 29-30 weeks post-menstrual age on the development of oral-motor function and sucking capacity. Study Design: This study was a single-blind randomized controlled experimental design. The sample consisted of 60 preterm babies from two Neonatal Intensive Care Units in Gaziantep, Turkey between May 2019 and March 2020, with 30 each in the control and experimental groups. The PIOMI was applied to the experimental group for five minutes a day for 14 consecutive days. Sucking capacity, growth, feeding outcomes, … |
SELVER GÜLER; | 2019-05-01 |
| 479 | A Phase 3 Open-Label Clinical Trial to Study The Immunogenicity and Safety of 9- Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine (V503) in Chinese Females 9 to 45 Years of Age PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: This study will investigate the immunogenicity and safety of the 9vHPV vaccine in healthy Chinese females 9 to 45 years of age. The study consists of Stage I (Day 1 to Month 7) and Stage II (post Month 7 to Month 60). Stage II will report the long-term immunogenicity and safety in the 9-19 year-old age group only. The dual-primary hypotheses of Stage I are that 9vHPV vaccine induces non-inferior immune responses in females 9 to 19 years of age who are seronegative at Day 1 to the relevant HPV type compared to females 20 to 26 years of age who are seronegative at Day 1 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 1 month post Dose 3, and 9vHPV vaccine induces non-inferior immune responses in females 27 to 45 years of age who are seronegative at Day 1 to the relevant HPV type compared to females 20 to 26 years of age who are seronegative at Day 1 to the relevant HPV type, as measured by the seroconversion percentages to each of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 1 month post Dose 3. (Each vaccine component will be analyzed separately.) |
MERCK SHARP & DOHME | 2019-04-27 |
| 480 | A Study to Evaluate The Safety, Tolerability, and Effect of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use As Maintenance Treatment in Adult and Adolescent Patients With Schizophrenia PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to evaluate the long-term safety and tolerability of TV-46000. The primary safety and tolerability endpoint is the frequency of all adverse events, including serious adverse events. For new participants, the total duration of participant participation in the study is planned to be up to 80 weeks (including a screening period of up to 4 weeks, a 12-week oral conversion/stabilization stage [Stage 1], a 56-week double-blind maintenance stage [Stage 2], and a follow-up period [8 weeks]). For roll-over participants, … |
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D | 2019-04-17 |
| 481 | A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001) PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS). As of Amendment 7 eligible participants on study completion will be able to transition to an extension study, if available, in which they can continue to receive pembrolizumab monotherapy, lenvatinib monotherapy, or a combination of both pembrolizumab and lenvatinib as received in the parent study. |
MERCK SHARP & DOHME | 2019-04-11 |
| 482 | Immunogenicity and Safety of An Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objectives of this study are: * To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine * To describe the antibody response to meningococcal serogroups A, C, W, … |
SANOFI PASTEUR A SANOFI COMPANY | 2019-04-09 |
| 483 | A Phase I, Double-Blind, Randomized, Multicenter Trial of The Safety,Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age). |
MERCK SHARP & DOHME | 2019-04-02 |
| 484 | A Phase 3, Long-Term Safety Study of Tirzepatide in Combination With Monotherapy of Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus (SURPASS J-combo) PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study is to determine the long-term safety of the study drug tirzepatide in combination with oral antihyperglycemic medications in participants with type 2 diabetes. |
ELI LILLY | 2019-03-30 |
| 485 | A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled Study of The Impact of Apremilast (CC-10004) on Quality of Life, Efficacy, and Safety in Subjects With Manifestations of Plaque Psoriasis and Impaired Quality of Life PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The primary objective of the study is to assess the impact of treatment with apremilast 30 mg twice daily for 16 weeks, compared to placebo, on health-related quality of life (QOL) in adults with manifestations of plaque psoriasis and impaired quality of life. |
AMGEN | 2019-03-28 |
| 486 | A Randomized, Double-blind, Placebo-controlled, Multicentre Phase 2 Study to Evaluate The Safety and Tolerability of Subcutaneous MOR106 Administered Concomitantly With Topical Corticosteroids for Eight Weeks, in Adult Subjects With Moderate to Severe Atopic Dermatitis PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: To investigate the safety and tolerability of repeated subcutaneous (s.c.) doses of MOR106 administered concomitantly with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy. |
GALAPAGOS NV | 2019-03-25 |
| 487 | A Phase 2, Open-label, Multicenter Study to Determine The Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of AG-348 in Adult Subjects With Non-transfusion-dependent Thalassemia PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Study AG348-C-010 is a multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of treatment with AG-348 in adult participants with non-transfusion-dependent thalassemia (NTDT). This study includes a core period (up to 24 weeks) followed by an extension period (up to 10 years) for eligible participants. 20 participants with NTDT were enrolled. The initial dose of AG-348 was 50 milligrams (mg) twice daily (BID) with one potential dose-level increase to 100 mg BID at the Week 6 visit based on the participant’s safety and hemoglobin (Hb) concentrations. |
AGIOS PHARMACEUTICALS | 2019-03-20 |
| 488 | Screening For Critical Congenital Anomalies In NICU And Their Out Come in Assiut Universty PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The congenital malformation (CMF) include disturbance in normal process of organogenesis occurring before birth . – The (CMF) are structural ,functional, or (biochemical Molecular) defect presenting at birth. – The structural defect resulting from prenatal insult during period of embryogeneses. – The neonate with congenital malformation have differences in physiology, anatomy, in response to stress. – The (CMF) are important causes of infant disability , illness, deaths. – (CMF) classified into mild, moderate, severe and lethal |
AMIRA THARWAT HELMY; | 2019-03-19 |
| 489 | A Phase III, Randomized, Partially Double- Blind, Active Control Study to Compare The Immunogenicity and Safety of A Liquid Formulation of ROTAVIN With The Currently Licensed Frozen Formulation of The Vaccine (ROTAVIN-M1), in Healthy Vietnamese Infants PF:4 Related Papers Related Patents Related Grants Related Experts View Highlight: This study is conducted to demonstrate non-inferiority in the immunogenicity of the liquid formulation of ROTAVIN in comparison to currently licensed frozen formulation of the vaccine (ROTAVIN-M1), 28 days after the second vaccination when administered as two dose series starting at 2-3 months of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination. |
CENTER FOR RESEARCH AND PRODUCTION OF VACCINES AND BIOLOGICALS VIETNAM | 2019-03-16 |
| 490 | Optimizing Pregnancy and Treatment Interventions for Moms 2.0 PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The US opioid epidemic continues to result in serious health consequences for pregnant and postpartum women. In the US from 2007 to 2012, an average of 21,000 pregnant women each year reported past month opioid misuse. This study aims to provide rapid and targeted primary prevention activities aimed at assisting pregnant women with opioid use disorder (OUD) to become linked to and retained in treatment in order to reduce harms to them (including overdose) and their offspring. |
JERRY COCHRAN; | 2019-03-11 |
| 491 | Evaluation of The Effect of The Combination of The Natural Products Glizigen® and Ocoxin®-Viusid® in The Treatment of High-grade Cervical Intraepithelial Lesions. Phase II PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: Phase II clinical trial, monocentric, not controlled, in patients with high grade cervical intraepithelial lesions. A total of 62 patients with a diagnosis of CIN II, III or carcinoma in situ will be included. It is expected that with the combination of natural products Glizigen® and Ocoxin®-Viusid® at least 60% of patients with treated intraepithelial lesions (IEL) have a global response (complete or partial), with elimination of the human papillomavirus and the viral load. |
ÁGUEDA SANTANA MARTÍNEZ; | 2019-03-11 |
| 492 | A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate The Safety and Immunogenicity of A 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Pichia Pastoris) in 9 to 45 Year Old Chinese Females PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females. |
XUECHENG LIU; | 2019-03-09 |
| 493 | A Phase I Randomized, Double-Blind, Placebo-controlled Study to Evaluate The Safety, Tolerability and Immunogenicity of V160 (Human Cytomegalovirus Vaccine) in Healthy Japanese Men PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to assess the safety and tolerability of a 3-dose regimen of V160 administered by intramuscular (IM) injection in healthy Japanese male participants by cytomegalovirus (CMV) serostatus. There is no formal hypothesis. |
MERCK SHARP & DOHME | 2019-03-08 |
| 494 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy and Safety of Padsevonil As Adjunctive Treatment of Focal-Onset Seizures in Adult Subjects With Drug-Resistant Epilepsy PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of the study is to evaluate the efficacy, safety and tolerability of the 3 selected dose regimens of padsevonil (PSL) administered concomitantly with up to 3 anti-epileptic drugs (AEDs) compared with placebo for treatment of observable focal-onset seizures in subjects with drug-resistant epilepsy. |
UCB BIOPHARMA SRL | 2019-03-06 |
| 495 | A Phase 1/2, Open-Label, Multicenter, Single-Arm Study to Assess The Safety, Tolerability, and Efficacy of BIVV003 for Autologous Hematopoietic Stem Cell Transplantation in Patients With Severe Sickle Cell Disease Related Papers Related Patents Related Grants Related Experts View Highlight: This is an open label, multicenter, Phase 1/2 study in approximately eight adults with severe Sickle Cell Disease (SCD). The study will evaluate the safety, tolerability, and efficacy of autologous hematopoietic stem cell transplantation using BIVV003. |
SANGAMO THERAPEUTICS | 2019-03-06 |
| 496 | An Open-Label, Multicenter, Single-arm Study to Evaluate The Immunogenicity of VARIVAX™ in Healthy Russian Individuals 12 Months of Age and Older PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine in healthy Russian children, adolescents, and adults. No formal hypothesis was tested. |
MERCK SHARP & DOHME | 2019-03-01 |
| 497 | A Phase I, Double-blind, Randomized, Placebo-controlled, Single Dose-escalation Study to Evaluate The Tolerability and Safety of Cytisine in Adult Smokers PF:2 Related Papers Related Patents Related Grants Related Experts View Highlight: The objectives of this study are: 1. To assess the tolerability and safety of cytisine as a single oral dose. 2. To define the Cmax levels associated to the occurrence of dose-limiting adverse events. |
MARLENE FONSECA; | 2019-02-28 |
| 498 | Post-marketing Safety Surveillance of Xueshuantong-Injection : A Registry Study PF:9 Related Papers Related Patents Related Grants Related Experts View Highlight: This registry aims to monitor the safety of Xueshuantong Injection and to identify the potential risk factors for the adverse drug reactions. |
ZHONG WANG; | 2019-02-18 |
| 499 | The Effectiveness and Safety of The Early Follicular Phase Prolonged Down-regulation Protocol for Controlled Ovarian Hyperstimulation: A Randomized, Paralleled, Controlled, Multicenter Trial PF:5 Related Papers Related Patents Related Grants Related Experts View Highlight: Since the first tube baby, Louise Brown, was born in the United Kingdom in 1978, many infertile couples have been benefitted from in vitro fertilization and embryo transfer (IVF-ET) and intracytoplasmic sperm injection (ICSI). Although a late starter, China is developing rapidly in ART and playing a more and more important role in the area of reproductive medicine. In spite of the continuous development in ART, so far, the overall success rate of IVF/ICSI is still hovering around 25-40%. There are many factors influencing the success rate of IVF/ICSI. Among them, … |
JIANG LI; | 2019-02-01 |
| 500 | A Phase 1/2, Open-label, Multi-center Study of The Safety and Efficacy of KY1044 As Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies PF:3 Related Papers Related Patents Related Grants Related Experts View Highlight: A Phase 1/2, open label, multi-center study to evaluate the safety, efficacy and tolerability of alomfilimab as single agent and in combination with anti-PD-L1 (atezolizumab) in adult patients with selected advanced malignancies, who are ineligible for or there are no available therapies known to confer a clinical benefit for their disease, or they have exhausted all such available options in each indication and therefore will be patients for whom a clinical trial is appropriate. |
KYMAB | 2019-01-28 |