Sotatercept in Japanese children with pulmonary arterial hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study investigates the safety and pharmacokinetics of sotatercept (MK-7962) in Japanese children with World Health Organization Group 1 PAH, alongside their usual PAH therapy. Participants will be Japanese children with PAH who have been on stable background therapy for at least 90 days. The study aims to understand how the drug behaves in the body and whether it reduces pulmonary vascular resistance. Enrollment is limited to specific Osaka and Tokyo area centers collaborating with Merck Sharp & Dohme LLC.

Why it matters

Who can join: the full rules

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

Where it's running

• Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)
  Izumi, Osaka, Japan Recruiting
• The University of Osaka Hospital ( Site 3201)
  Suita, Osaka, Japan Recruiting
• National Center for Child Health and Development ( Site 3202)
  Setagaya City, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.