NL-OMON53701
Not yet recruiting
Phase 2
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 - MK7962-008
Merck Sharp & Dohme (MSD)0 sites1 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Merck Sharp & Dohme (MSD)
- Enrollment
- 1
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The main inclusion criteria are listed here. For a complete list of inclusion
- •please refer to the research protocol.
- •1\. Male or female participants \>\=1 to \<18 years of age at the time of providing
- •documented informed consent/assent:
- •Cohort 1: Age \>\=12 to \<18 years of age
- •Cohort 2: Age \>\=6 to \<12 years of age
- •Cohort 3: Age \>\=2 to \<6 years of age
- •Cohort 4: Age \>\=1 to \<2 years of age
- •2\. Documented, historic diagnostic RHC any time before Screening confirming the
- •diagnosis of PAH WHO Group 1\.
Exclusion Criteria
- •The main exclusion criteria are listed here. For a complete list of exclusion
- •please refer to the research
- •1\. 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)
- •2 Severe (as based on the opinion of the investigator) congenital or
- •developmental abnormalities of the lung, thorax, and/or diaphragm
- •3\. History of Eisenmenger syndrome, Potts shunt, atrial septostomy within 180
- •days prior to the screening visit, or atrial septostomy with Eisenmenger
Outcomes
Primary Outcomes
Not specified
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