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NCT05587712PHASE2Recruiting

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

Merck Sharp & Dohme LLC

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

Inclusion Criteria * Documented, historic diagnostic right heart catheterization (RHC) any time before Screening confirming the diagnosis of PAH WHO Group 1 in any of the following subtypes: * Idiopathic pulmonary arterial hypertension (IPAH) * Heritable PAH * Drug/toxin-induced PAH * PAH associated with connective tissue disease * PAH-congenital heart disease (CHD) with shunt closure \>6 months before Screening and subsequently confirmed by RHC before Screening * PAH with coincidental shunt. * Must be on a stable dose(s) of background PAH therapy (phosphdiesterase-5 (PDE5) inhibitors, endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulators (sGCS), or prostanoids \[including subcutaneous and intravenous\]) * If male, agree to the following during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention: * Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent or * Uses contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview) as detailed below: * Uses a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration. * If female, must be either not a WOCBP or use a contraceptive method that is highly effective or be abstinent from heterosexual intercourse during the intervention period and for at least 16 weeks (112 days) after the last dose of study intervention * If male, agrees to refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study intervention * If female, agrees to refrain from donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study intervention Exclusion Criteria * History of left-sided heart disease, including valvular disease (eg, moderate or greater mitral or aortic regurgitation or stenosis), left ventricular outflow tract obstruction, and/or left heart failure (eg, restrictive or dilated cardiomyopathy) * Severe (as based on the opinion of the investigator) congenital or developmental abnormalities of the lung, thorax, and/or diaphragm * History of Eisenmenger syndrome, Potts shunt, or atrial septostomy * Unrepaired or residual cardiac shunt * Diagnosis of pulmonary veno-occlusive diseases, pulmonary capillary hemangiomatosis, or overt signs of capillary and/or venous involvement * PAH associated with portal hypertension * Known visceral (lung, liver, or brain) arteriovenous malformation(s) * History of full or partial pneumonectomy * Untreated more than mild obstructive sleep apnea * History of known pericardial constriction * Family history of sudden cardiac death or long QT syndrome * Any current or prior history of symptomatic coronary disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months before Screening * Cerebrovascular accident within 3 months before Screening * Prior exposure to sotatercept or luspatercept or has had an allergic reaction to any of their excipients

Interventions

DRUG

Sotatercept

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Conditions

Pulmonary Arterial Hypertension

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