RECRUITING

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

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Conditions

Pulmonary Arterial Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-19
Study Completion:2028-09-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05587712

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.

Ages Eligible for Study:1 Year to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)
Los Angeles, California, 90095
United States
Stanford University School of Medicine ( Site 1603)
Palo Alto, California, 94304
United States
UCSF Benioff Children's Hospital San Francisco ( Site 1611)
San Francisco, California, 94158
United States
Children's Hospital Colorado ( Site 1609)
Aurora, Colorado, 80045
United States
Children's National Medical Center ( Site 1600)
Washington, District of Columbia, 20010
United States
Cincinnati Children's Hospital Medical Center ( Site 1602)
Cincinnati, Ohio, 45245
United States
Children's Hospital of Philadelphia (CHOP) ( Site 1608)
Philadelphia, Pennsylvania, 19104
United States
Monroe Carell Jr. Children's Hospital ( Site 1601)
Nashville, Tennessee, 37232
United States
Seattle Children's Hospital ( Site 1605)
Seattle, Washington, 98105
United States
Children's Wisconsin ( Site 1610)
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-19
Study Completion Date2028-09-21

Study Record Updates

Study Start Date2023-01-19
Study Completion Date2028-09-21

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Arterial Hypertension