Tests sotatercept in Japanese children with pulmonary arterial hypertension
Tests sotatercept, added to usual care, in Japanese children with lung high blood pressure.
Plain-language title generated from the registry record
Registry title: A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
Key facts
- Where
- Izumi, Setagaya City, and Suita, JapanSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 17 years old?
Source: NCT07646860, who can take part
Where in Japan
- Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital (Site 3203)Izumi, JapanTaking people
- National Center for Child Health and Development (Site 3202)Setagaya City, JapanTaking people
- The University of Osaka Hospital (Site 3201)Suita, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07646860
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: The main inclusion criteria include but are not limited to the following:; Has pulmonary arterial hypertension (PAH, World Health Organization Group 1) confirmed by a prior right heart catheterization; Has idiopathic, heritable, drug- or toxin-induced PAH, connective tissue disease-associated PAH, repaired congenital heart disease-associated PAH, or PAH with coincidental shunt; Has PAH classified as World Health Organization Functional Class I, or symptomatic World Health Organization Functional Class II to IV; Has been receiving stable standard-of-care background therapy for PAH for at least 90 days; Is Japanese.
Exclusion: Prior treatment with sotatercept or luspatercept; History of left-sided heart disease; History of Eisenmenger syndrome, Potts shunt, or recent atrial septostomy within 180 days; Has unrepaired or residual cardiac shunt with Qp/Qs >1.5; Has pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or overt signs of pulmonary capillary and/or venous involvement; PAH associated with portal hypertension; History of full or partial pneumonectomy; History of known pericardial constriction; History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months; Family history of sudden cardiac death or long QT syndrome; The main exclusion criteria include but are not limited to the following:; Has severe congenital or developmental abnormalities of the lung, thorax, and/or diaphragm; Known visceral arteriovenous malformations; Untreated more than mild obstructive sleep apnea.