Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
NCT ID: NCT05587712
Last Updated: 2026-01-21
Study Results
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Basic Information
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RECRUITING
PHASE2
42 participants
INTERVENTIONAL
2023-01-19
2028-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Children ≥1 to <18 years old
Participants will receive a subcutaneous (SC) injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Sotatercept
SC injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Interventions
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Sotatercept
SC injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
17 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-7962-008
Identifier Type: OTHER
Identifier Source: secondary_id
2023-504861-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-2858
Identifier Type: REGISTRY
Identifier Source: secondary_id
2022-000478-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7962-008
Identifier Type: -
Identifier Source: org_study_id
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