Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05587712
PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

DRUG

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