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Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Sponsor: 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.
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
Key Details
Gender
All
Age Range
1 Year - 17 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2023-01-19
Completion Date
2028-09-21
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Sotatercept
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, United States
Stanford University School of Medicine ( Site 1603)
Palo Alto, California, United States
UCSF Benioff Children's Hospital San Francisco ( Site 1611)
San Francisco, California, United States
Children's Hospital Colorado ( Site 1609)
Aurora, Colorado, United States
Children's National Medical Center ( Site 1600)
Washington D.C., District of Columbia, United States
Cincinnati Children's Hospital Medical Center ( Site 1602)
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia (CHOP) ( Site 1608)
Philadelphia, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital ( Site 1601)
Nashville, Tennessee, United States
Seattle Children's Hospital ( Site 1605)
Seattle, Washington, United States
Children's Wisconsin ( Site 1610)
Milwaukee, Wisconsin, United States
The Children's Hospital at Westmead ( Site 0001)
Westmead, New South Wales, Australia
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)
Rionegro, Antioquia, Colombia
Fundación Valle del Lili ( Site 0200)
Cali, Valle del Cauca Department, Colombia
Clínica Imbanaco S.A.S ( Site 0203)
Cali, Valle del Cauca Department, Colombia
CHU de Toulouse - Hôpital des Enfants ( Site 0302)
Toulouse, Haute-Garonne, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hôpital Universitaire Necker Enfants Malades ( Site 0300)
Paris, France
Universitaetsklinikum Heidelberg ( Site 0401)
Heidelberg, Baden-Wurttemberg, Germany
Klinikum der Universität München Großhadern ( Site 0404)
München, Bavaria, Germany
Medizinische Hochschule Hannover ( Site 0405)
Hanover, Lower Saxony, Germany
Schneider Children's Medical Center ( Site 0603)
Petah Tikva, Israel
Sheba Medical Center ( Site 0601)
Ramat Gan, Israel
University Medical Center Groningen ( Site 0900)
Groningen, Netherlands
Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)
Gdansk, Pomeranian Voivodeship, Poland
Wits Clinical Research-Wits Clinical Research Bara ( Site 1201)
Johannesburg, Soweto, Gauteng, South Africa
Hospital Universitario Ramón y Cajal ( Site 1300)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari i Politecnic La Fe ( Site 1303)
Valencia, Valencia, Spain
Hospital Universitari Vall d'Hebron ( Site 1302)
Barcelona, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)
Madrid, Spain
Hacettepe Universite Hastaneleri ( Site 1400)
Ankara, Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim ( Site 1402)
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 1403)
Ankara, Turkey (Türkiye)
Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)
Istanbul, Turkey (Türkiye)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
London, London, City of, United Kingdom