NCT07646860RecruitingPhase 2
A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
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.
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 9 Jun 2026
- Start date
- 17 Sept 2026
- Primary completion date
- 24 May 2029
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT07646860
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 6
- From 17 Sept 2026 to the primary completion date, 24 May 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with sotatercept or luspatercept
Other illness
- 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
Lab values
- Family history of sudden cardiac death or long QT syndrome
Other
- 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
Who the study is looking for
- 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
Age in the registry: 1 year to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203) Coordinator of this site? Confirm its status | Izumi | Japan | Recruiting |
| National Center for Child Health and Development ( Site 3202) Coordinator of this site? Confirm its status | Setagaya City | Japan | Recruiting |
| The University of Osaka Hospital ( Site 3201) Coordinator of this site? Confirm its status | Suita | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.