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Recruiting Phase 2 NCT05587712

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

Phase 2 – studying effectiveness and dosage
Conditions: Pulmonary Arterial Hypertension

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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
Sotatercept
DRUG
Locations 35
Australia (1)
The Children's Hospital at Westmead ( Site 0001)
Westmead , New South Wales
Study Coordinator
Colombia (3)
Fundación Valle del Lili ( Site 0200)
Cali , Valle del Cauca Department
Study Coordinator
Clínica Imbanaco S.A.S ( Site 0203)
Cali , Valle del Cauca Department
Study Coordinator
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)
Rionegro , Antioquia
Study Coordinator
France (3)
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)
Marseille , Provence-Alpes-Côte d'Azur Region
Study Coordinator
Hôpital Universitaire Necker Enfants Malades ( Site 0300)
Paris
Study Coordinator
CHU de Toulouse - Hôpital des Enfants ( Site 0302)
Toulouse , Haute-Garonne
Study Coordinator
Germany (3)
Medizinische Hochschule Hannover ( Site 0405)
Hanover , Lower Saxony
Study Coordinator
Universitaetsklinikum Heidelberg ( Site 0401)
Heidelberg , Baden-Wurttemberg
Study Coordinator
Klinikum der Universität München Großhadern ( Site 0404)
München , Bavaria
Study Coordinator
Israel (2)
Schneider Children's Medical Center ( Site 0603)
Petah Tikva
Study Coordinator
Sheba Medical Center ( Site 0601)
Ramat Gan
Study Coordinator
Netherlands (1)
University Medical Center Groningen ( Site 0900)
Groningen
Study Coordinator
Poland (2)
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)
Gdansk , Pomeranian Voivodeship
Study Coordinator
Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)
Warsaw , Masovian Voivodeship
Study Coordinator
South Africa (1)
Wits Clinical Research-Chris Hani Baragwanath Hospital ( Site 1201)
Johannesburg, Soweto , Gauteng
Study Coordinator
Spain (4)
Hospital Universitari Vall d'Hebron ( Site 1302)
Barcelona
Study Coordinator
Hospital Universitario Ramón y Cajal ( Site 1300)
Madrid , Madrid, Comunidad de
Study Coordinator
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)
Madrid
Study Coordinator
Hospital Universitari i Politecnic La Fe ( Site 1303)
Valencia , Valencia
Study Coordinator
Turkey (4)
Hacettepe Universite Hastaneleri ( Site 1400)
Ankara
Study Coordinator
Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim ( Site 1402)
Ankara
Study Coordinator
Ankara Bilkent Şehir Hastanesi. ( Site 1403)
Ankara
Study Coordinator
Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)
Istanbul
Study Coordinator
United Kingdom (1)
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
London , London, City of
Study Coordinator
United States (10)
Children's Hospital Colorado ( Site 1609)
Aurora , Colorado
Study Coordinator
Cincinnati Children's Hospital Medical Center ( Site 1602)
Cincinnati , Ohio
Study Coordinator
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)
Los Angeles , California
Study Coordinator
Children's Wisconsin ( Site 1610)
Milwaukee , Wisconsin
Study Coordinator
Monroe Carell Jr. Children's Hospital ( Site 1601)
Nashville , Tennessee
COMPLETED
Stanford University School of Medicine ( Site 1603)
Palo Alto , California
Study Coordinator
Children's Hospital of Philadelphia (CHOP) ( Site 1608)
Philadelphia , Pennsylvania
Study Coordinator
UCSF Benioff Children's Hospital San Francisco ( Site 1611)
San Francisco , California
Study Coordinator
Seattle Children's Hospital ( Site 1605)
Seattle , Washington
Study Coordinator
Children's National Medical Center ( Site 1600)
Washington D.C. , District of Columbia
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
17 Years
Healthy volunteers
No
Start date
19.01.2023
Completion date
21.09.2028
Registry ID
NCT05587712
Source
clinicaltrials.gov
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