Sotatercept for Pulmonary Arterial Hypertension in Kids

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

Recruiting Phase 2 Interventional Study
Pulmonary Arterial Hypertension
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
1 – 17
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
Merck Sharp & Dohme LLC · Industry
Who this trial is looking for

This trial is looking for children aged 1 to under 18 with pulmonary arterial hypertension (PAH). Participants will receive treatment with sotatercept over 24 weeks to evaluate safety and how the body processes the drug.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with pulmonary arterial hypertension (PAH).
  • I am between 1 and 18 years old.
  • I am on a stable dose of my PAH medication.
  • If I am male, I will use contraception or remain abstinent.
  • If I am female, I will use a highly effective contraceptive or remain abstinent.
  • I will not donate blood or sperm during the study.
  • I will not donate blood, eggs, or ovum if I am female.

You may not be able to join if

  • I have had left-sided heart disease.
  • I have severe lung or diaphragm abnormalities.
  • I have a history of Eisenmenger syndrome.
  • I have an untreated obstructive sleep apnea.
  • I have any history of coronary disease in the past 6 months.
  • I had a cerebrovascular accident in the past 3 months.
  • I am allergic to sotatercept or luspatercept.
  • I have a history of pericardial constriction.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria * Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes: * Idiopathic pulmonary arterial hypertension (IPAH) * Heritable PAH * Drug/toxin-induced PAH * PAH associate…
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