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

Description

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.

Conditions

Pulmonary Arterial Hypertension

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pulmonary Arterial Hypertension
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606), Los Angeles, California, United States, 90095

Palo Alto

Stanford University School of Medicine ( Site 1603), Palo Alto, California, United States, 94304

San Francisco

UCSF Benioff Children's Hospital San Francisco ( Site 1611), San Francisco, California, United States, 94158

Aurora

Children's Hospital Colorado ( Site 1609), Aurora, Colorado, United States, 80045

Washington

Children's National Medical Center ( Site 1600), Washington, District of Columbia, United States, 20010

Cincinnati

Cincinnati Children's Hospital Medical Center ( Site 1602), Cincinnati, Ohio, United States, 45245

Philadelphia

Children's Hospital of Philadelphia (CHOP) ( Site 1608), Philadelphia, Pennsylvania, United States, 19104

Nashville

Monroe Carell Jr. Children's Hospital ( Site 1601), Nashville, Tennessee, United States, 37232

Seattle

Seattle Children's Hospital ( Site 1605), Seattle, Washington, United States, 98105

Milwaukee

Children's Wisconsin ( Site 1610), Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    1 Year to 17 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Merck Sharp & Dohme LLC,

    Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

    Study Record Dates

    2028-09-21