A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-17
SponsorMerck Sharp & Dohme LLC

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sotatercept

Treatment groups

6 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators