Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Start Date
1/19/2023
Completion Date
9/21/2028
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.
Eligibility Criteria
Age Range: 1 years to 17 years
Interventions
Sotatercept
Conditions
Locations
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 D.C., District of Columbia 20010
United States
Cincinnati Children's Hospital Medical Center ( Site 1602)
Cincinnati, Ohio 45229
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
The Children's Hospital at Westmead ( Site 0001)
Westmead, New South Wales 2145
Australia
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)
Rionegro, Antioquia 054040
Colombia
Fundación Valle del Lili ( Site 0200)
Cali, Valle del Cauca Department 760032
Colombia
Clínica Imbanaco S.A.S ( Site 0203)
Cali, Valle del Cauca Department 760042
Colombia
CHU de Toulouse - Hôpital des Enfants ( Site 0302)
Toulouse, Haute-Garonne 31059
France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)
Marseille, Provence-Alpes-Côte d'Azur Region 13005
France
Hôpital Universitaire Necker Enfants Malades ( Site 0300)
Paris, 75015
France
Universitaetsklinikum Heidelberg ( Site 0401)
Heidelberg, Baden-Wurttemberg 69120
Germany
Klinikum der Universität München Großhadern ( Site 0404)
München, Bavaria 81337
Germany
Medizinische Hochschule Hannover ( Site 0405)
Hanover, Lower Saxony 30625
Germany
Schneider Children's Medical Center ( Site 0603)
Petah Tikva, 4920235
Israel
Sheba Medical Center ( Site 0601)
Ramat Gan, 5265601
Israel
University Medical Center Groningen ( Site 0900)
Groningen, 9713 GZ
Netherlands
Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)
Warsaw, Masovian Voivodeship 04-730
Poland
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)
Gdansk, Pomeranian Voivodeship 80-952
Poland
Wits Clinical Research-Chris Hani Baragwanath Hospital ( Site 1201)
Johannesburg, Soweto, Gauteng 2013
South Africa
Hospital Universitario Ramón y Cajal ( Site 1300)
Madrid, Madrid, Comunidad de 28034
Spain
Hospital Universitari i Politecnic La Fe ( Site 1303)
Valencia, Valencia 46026
Spain
Hospital Universitari Vall d'Hebron ( Site 1302)
Barcelona, 08035
Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)
Madrid, 28007
Spain
Hacettepe Universite Hastaneleri ( Site 1400)
Ankara, 06100
Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim ( Site 1402)
Ankara, 06560
Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi. ( Site 1403)
Ankara, 06800
Turkey (Türkiye)
Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)
Istanbul, 34303
Turkey (Türkiye)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
London, London, City of WC1N 3JH
United Kingdom