NCT07646860 A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)
| NCT ID | NCT07646860 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2026-09-25 |
| Primary Completion | 2029-05-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 6 participants in total. It began in 2026-09-25 with a primary completion date of 2029-05-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: The main exclusion criteria include but are not limited to the following: * History of left-sided heart disease * Has severe congenital or developmental abnormalities of the lung, thorax, and/or diaphragm * 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 * Known visceral arteriovenous malformations * History of full or partial pneumonectomy * Untreated more than mild obstructive sleep apnea * History of known pericardial constriction * Family history of sudden cardiac death or long QT syndrome * History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months * Prior treatment with sotatercept or luspatercept
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07646860 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07646860 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07646860 currently recruiting?
Yes, NCT07646860 is actively recruiting participants. Contact the research team at Trialsites@merck.com for enrollment information.
Where is the NCT07646860 trial being conducted?
This trial is being conducted at Izumi, Japan, Suita, Japan, Setagaya City, Japan.
Who is sponsoring the NCT07646860 clinical trial?
NCT07646860 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 6 participants.