A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
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.
Conditions studied
Pulmonary Arterial Hypertension
About this study
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.
Interventions
- Biological: Sotatercept — Sotatercept subcutaneous injection every 3 weeks
Primary outcomes
- Number of Participants With One or More Adverse Events (Up to approximately 24 weeks)
- Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (Up to approximately 24 weeks)
- Laboratory Parameter (Hematology): Concentration of Hemoglobin (Up to approximately 24 weeks)
- Laboratory Parameter (Hematology): Hematocrit (Up to approximately 24 weeks)
- Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count (Up to approximately 24 weeks)
- Laboratory Parameter (Hematology): Reticulocyte Count (Up to approximately 24 weeks)
- Laboratory Parameter (Hematology): Platelet Count (Up to approximately 24 weeks)
- Blood Pressure (BP) (Up to approximately 24 weeks)
Eligibility information
Study locations
- Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203), Izumi, Osaka 594-1101 Japan
- The University of Osaka Hospital ( Site 3201), Suita, Osaka 565-0871 Japan
- National Center for Child Health and Development ( Site 3202), Setagaya City, Tokyo 157-8535 Japan
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.