RecruitingPhase 2NCT05587712

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

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

42 participants

Start Date

Jan 19, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 YearMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called sotatercept in children with pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the arteries going to the lungs is dangerously high. The goal is to see if this drug is safe and effective in younger patients. **You may be eligible if...** - You are a child with a confirmed diagnosis of PAH (Group 1), including inherited PAH, idiopathic PAH, PAH from a drug or toxin, PAH linked to connective tissue disease, or PAH associated with a repaired heart defect - You are already on stable doses of at least one standard PAH medication **You may NOT be eligible if...** - You have left-sided heart disease, heart valve problems, or heart failure - You have severe abnormalities of the lungs, chest wall, or diaphragm - You have certain other heart or lung conditions that could make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSotatercept

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-Chris Hani Baragwanath Hospital ( 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

View Full Details on ClinicalTrials.gov

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NCT05587712


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