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.
Age range
1 Year – 17 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With One or More Adverse Events
Timeframe: Up to approximately 24 weeks
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Timeframe: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Timeframe: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Hematocrit
Timeframe: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Timeframe: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Reticulocyte Count
Timeframe: Up to approximately 24 weeks
Laboratory Parameter (Hematology): Platelet Count
Timeframe: Up to approximately 24 weeks
Blood Pressure (BP)
Timeframe: Up to approximately 24 weeks
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Timeframe: Up to approximately 24 weeks
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Timeframe: Up to approximately 24 weeks
Serum Trough Concentration (Ctrough) of Sotatercept
Timeframe: At designated time points and up to approximately 24 weeks
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI)
Timeframe: Baseline and Week 24