Phase
Condition
Pulmonary Arterial Hypertension
Vascular Diseases
Stress
Treatment
Sotatercept
Clinical Study ID
Ages 1-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Connect with a study center
The Children's Hospital at Westmead ( Site 0001)
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)
Rionegro, Antioquia 054040
ColombiaActive - Recruiting
Clínica Imbanaco S.A.S ( Site 0203)
Cali, Valle Del Cauca 760042
ColombiaActive - Recruiting
Fundacion Valle del Lili- CIC ( Site 0200)
Cali, Valle Del Cauca 760032
ColombiaActive - Recruiting
Fundación Valle del Lili ( Site 0200)
Cali, Valle Del Cauca 760032
ColombiaActive - Recruiting
CHU de Toulouse - Hôpital des Enfants ( Site 0302)
Toulouse, Haute-Garonne 31059
FranceActive - Recruiting
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)
Marseille, Provence-Alpes-Cote-d Azur 13005
FranceActive - Recruiting
Hôpital Universitaire Necker Enfants Malades ( Site 0300)
Paris, 75015
FranceActive - Recruiting
Universitaetsklinikum Heidelberg ( Site 0401)
Heidelberg, Baden-Wurttemberg 69120
GermanyActive - Recruiting
Klinikum der Universität München Großhadern ( Site 0404)
München, Bayern 81337
GermanyActive - Recruiting
Medizinische Hochschule Hannover ( Site 0405)
Hannover, Niedersachsen 30625
GermanyActive - Recruiting
Schneider Children's Medical Center ( Site 0603)
Petah-Tikva, 4920235
IsraelActive - Recruiting
Sheba Medical Center ( Site 0601)
Ramat Gan, 5265601
IsraelActive - Recruiting
University Medical Center Groningen ( Site 0900)
Groningen, 9713GZ
NetherlandsActive - Recruiting
Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)
Warszawa, Mazowieckie 04-730
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)
Gdańsk, Pomorskie 80-952
PolandActive - Recruiting
Wits Clinical Research-Wits Clinical Research Bara ( Site 1201)
Johannesburg, Soweto, Gauteng 2013
South AfricaActive - Recruiting
Hospital Universitario Ramón y Cajal ( Site 1300)
Madrid, Madrid, Comunidad De 28034
SpainActive - Recruiting
Hospital Universitari i Politecnic La Fe ( Site 1303)
València, Valencia 46026
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron ( Site 1302)
Barcelona, 08035
SpainActive - Recruiting
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)
Madrid, 28007
SpainActive - Recruiting
Ankara Bilkent Şehir Hastanesi. ( Site 1403)
Ankara, 06800
TurkeyActive - Recruiting
Ankara City Hospital ( Site 1403)
Ankara, 06800
TurkeyActive - Recruiting
Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim
Ankara, 06560
TurkeyActive - Recruiting
Hacettepe Universite Hastaneleri ( Site 1400)
Ankara, 06100
TurkeyActive - Recruiting
Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)
Istanbul, 34303
TurkeyActive - Recruiting
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
London, London, City Of WC1N 3JH
United KingdomActive - Recruiting
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)
Los Angeles, California 90095
United StatesActive - Recruiting
Stanford University School of Medicine ( Site 1603)
Palo Alto, California 94304
United StatesActive - Recruiting
UCSF Benioff Children's Hospital San Francisco ( Site 1611)
San Francisco, California 94158
United StatesActive - Recruiting
Children's Hospital Colorado ( Site 1609)
Aurora, Colorado 80045
United StatesActive - Recruiting
Children's National Medical Center ( Site 1600)
Washington, District of Columbia 20010
United StatesActive - Recruiting
Cincinnati Children's Hospital Medical Center ( Site 1602)
Cincinnati, Ohio 45245
United StatesActive - Recruiting
Children's Hospital of Philadelphia (CHOP) ( Site 1608)
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
Monroe Carell Jr. Children's Hospital ( Site 1601)
Nashville, Tennessee 37232
United StatesActive - Recruiting
Seattle Children's Hospital ( Site 1605)
Seattle, Washington 98105
United StatesActive - Recruiting
Children's Wisconsin ( Site 1610)
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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