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A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
Sponsor: Merck Sharp & Dohme LLC
Summary
The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.
Official title: A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.
Key Details
Gender
All
Age Range
1 Year - 17 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2026-09-17
Completion Date
2031-05-16
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Sotatercept
Sotatercept subcutaneous injection every 3 weeks
Locations (3)
Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)
Izumi, Osaka, Japan
The University of Osaka Hospital ( Site 3201)
Suita, Osaka, Japan
National Center for Child Health and Development ( Site 3202)
Setagaya City, Tokyo, Japan