A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Sotatercept (MK-7962) in Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care
Merck Sharp & Dohme LLC
Summary
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
- Age range
- 1–17 years
- Sex
- All
- Healthy volunteers
- No
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 associated with connective tissue disease * PAH-congenital heart disease (CHD) with shunt closure \>6 months before Screening and subsequently confirmed by RHC before Screening * PAH with coincidental shunt. * Must be on a stable dose(s) of background PAH therapy (phosphdiesterase-5 (PDE5) inhibitors, endoth…
Interventions
- DrugSotatercept
SC injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Locations (35)
- The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)Los Angeles, California
- Stanford University School of Medicine ( Site 1603)Palo Alto, California
- UCSF Benioff Children's Hospital San Francisco ( Site 1611)San Francisco, California
- Children's Hospital Colorado ( Site 1609)Aurora, Colorado
- Children's National Medical Center ( Site 1600)Washington D.C., District of Columbia
- Cincinnati Children's Hospital Medical Center ( Site 1602)Cincinnati, Ohio