Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT05587712
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Pulmonary Arterial Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sotatercept — DRUGSC injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Study Details
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.
Key Dates
- Start date
- Jan 19, 2023
- Status verified
- Apr 2026
- Primary completion
- Sep 21, 2028
- Completion
- Sep 21, 2028
Study Design
- Enrollment
- 42 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Children ≥1 to <18 years oldParticipants will receive a subcutaneous (SC) injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Primary Outcome Measure
Serum Trough Concentration (Ctrough) of Sotatercept [ Time Frame: Predose Day 1, Day 21, Day 42, Day 63, Day 84, Day105, Day 126, Day 147, Day 168, Day 189. Postdose Day 7, Day 14, Day 64, Day 69 and Day 76 ]
Central Contacts
- Toll Free Number1-888-577-8839
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606) | Los Angeles | California | 90095 | Study Coordinator 310-267-7667 |
| Stanford University School of Medicine ( Site 1603) | Palo Alto | California | 94304 | Study Coordinator 650-497-8000 |
| UCSF Benioff Children's Hospital San Francisco ( Site 1611) | San Francisco | California | 94158 | Study Coordinator 415-476-3831 |
| Children's Hospital Colorado ( Site 1609) | Aurora | Colorado | 80045 | Study Coordinator 720-777-6427 |
| Children's National Medical Center ( Site 1600) | Washington D.C. | District of Columbia | 20010 | Study Coordinator 202-476-2130 |
| Cincinnati Children's Hospital Medical Center ( Site 1602) | Cincinnati | Ohio | 45229 | Study Coordinator 513-636-7072 |
| Children's Hospital of Philadelphia (CHOP) ( Site 1608) | Philadelphia | Pennsylvania | 19104 | Study Coordinator 267-426-0120 |
| Monroe Carell Jr. Children's Hospital ( Site 1601) | Nashville | Tennessee | 37232 | - |
| Seattle Children's Hospital ( Site 1605) | Seattle | Washington | 98105 | Study Coordinator 206-987-2000 |
| Children's Wisconsin ( Site 1610) | Milwaukee | Wisconsin | 53226 | Study Coordinator 414-266-2000 |
Find similar trials in Los Angeles, CA
By research site
The Regents of the University of California - Los Angeles (UCLA Pediatrics)· Los Angeles, CAStanford University School of Medicine· Palo Alto, CAUCSF Benioff Children's Hospital San Francisco· San Francisco, CAChildren's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCCincinnati Children's Hospital Medical Center· Cincinnati, OH
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