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NCT ID: NCT04777201 Active, not recruiting - Clinical trials for Neovascular Age-related Macular Degeneration

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

AVONELLE-X
Start date: April 19, 2021
Phase: Phase 3
Study type: Interventional

This main long-term extension study is designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval (PTI) to participants with neovascular age-related macular degeneration (nAMD) who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this main study will be enrolled upon completion of the end-of-study visit in the parent study. Additionally, there is a substudy that is being conducted. The aim of this substudy is to evaluate the impact of intravitreal faricimab on the health of the corneal endothelial cells in the study eyes of patients with nAMD to fulfill a U.S. Food and Drug Administration (FDA) post-marketing requirement. The fellow eyes of the same enrolled participants in the substudy will serve as the controls.

NCT ID: NCT04776252 Active, not recruiting - HIV-1 Infection Clinical Trials

Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)

Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine (DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical studies.

NCT ID: NCT04776148 Active, not recruiting - Clinical trials for Colorectal Neoplasms

Study of Lenvatinib (MK-7902/E7080) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care in Participants With Metastatic Colorectal Cancer (MK-7902-017/E7080-G000-325/LEAP-017)

Start date: March 29, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in participants with metastatic colorectal cancer. The study will also compare lenvatinib plus pembrolizumab with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil hydrochloride). The primary study hypothesis is that lenvatinib plus pembrolizumab is superior to standard of care with respect to overall survival.

NCT ID: NCT04776135 Completed - Clinical trials for Healthy Adult Subjects

Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube

Start date: February 26, 2021
Phase: Phase 1
Study type: Interventional

To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects

NCT ID: NCT04774731 Completed - Hemodialysis Clinical Trials

Effect of Whole Body Vibration on Walking Performance in Elderly Hemodialysis Patients

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of whole body vibration for 12 weeks on walking performance in elderly hemodialysis patients.

NCT ID: NCT04773522 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of JNJ-64407564 in Japanese Participants With Relapsed or Refractory Multiple Myeloma

Start date: May 20, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability in Japanese participants with relapsed or refractory multiple myeloma (MM) at the recommended Phase 2 dose (RP2D) identified in NCT03399799 study.

NCT ID: NCT04773314 Completed - Pregnancy Clinical Trials

General Drug Use-results Survey on PROPESS Vaginal Inserts in Treatment for Initiation of Cervical Ripening in Patients at Term (From 37 Completed Weeks of Gestation)

Start date: February 28, 2021
Phase:
Study type: Observational

To confirm and consider the occurrence of important identified risks described in the Japanese Pharmaceutical Risk Management Plan (J-RMP) under conditions used in routine medical practice. The safety specification include: uterine hypercontractions and associated foetal distress, uterine rupture, cervical laceration, amniotic fluid embolism, and foetal distress.

NCT ID: NCT04772534 Completed - Clinical trials for Papillomavirus Infections

Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

Start date: May 17, 2021
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04772079 Recruiting - Plaque Psoriasis Clinical Trials

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

Start date: March 23, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in pediatric participants aged 4 to <18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to <18 years) and Cohort 2 (age 4 to <12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in pediatric participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in pediatric participants with psoriasis who have completed Parts A or B of the study.

NCT ID: NCT04771780 Completed - Hyperphosphatemia Clinical Trials

Phosphate Binder Switch Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis

Start date: March 15, 2021
Phase: Phase 3
Study type: Interventional

To investigate the safety of repeated administration of KHK7791 for 52 weeks while switching from a phosphate-binding agent to KHK7791 in Hemodialysis patients with hyperphosphatemia.