Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-17
SponsorMerck Sharp & Dohme LLC

About this trial

The primary objectives of the study are to evaluate the safety and tolerability, and pharmacokinetics (PK) of sotatercept over 24 weeks of treatment in children ≥1 to \<18 years of age with PAH World Health Organization (WHO) Group 1 on standard of care (SoC). There is no formal hypothesis.

Eligibility criteria

Qualifiers

Idiopathic pulmonary arterial hypertension (IPAH)

Heritable PAH

Drug/toxin-induced PAH

PAH associated with connective tissue disease

Disqualifiers

History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and/or left heart failure (eg, restrictive or dilated cardiomyopathy)

Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and/or diaphragm

History of Eisenmenger syndrome, Potts shunt, or atrial septostomy

Unrepaired or residual cardiac shunt

Trial design

Treatments tested in this trial

  • Sotatercept

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators