Actively Recruiting
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-20
42
Participants Needed
35
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate Sotatercept (MK-7962) in Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-008)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to less than 18 years with documented pulmonary arterial hypertension (PAH) WHO Group 1
- Diagnosed by historic right heart catheterization confirming PAH subtypes including idiopathic, heritable, drug/toxin-induced, connective tissue disease-associated, congenital heart disease with shunt closure >6 months before screening, or PAH with coincidental shunt
- On stable doses of background PAH therapies such as PDE5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators, or prostanoids
- Males must agree to abstain from heterosexual intercourse or use contraception during and for 16 weeks after the study, and refrain from donating blood or sperm during this time
- Females must be either not women of childbearing potential or use highly effective contraception or abstain from heterosexual intercourse during and for 16 weeks after the study, and refrain from donating blood, eggs, or ovum during this time
You will not qualify if you...
- History of left-sided heart disease including moderate or greater valve disease, left ventricular outflow obstruction, or left heart failure
- Severe congenital or developmental abnormalities of lung, thorax, or diaphragm
- History of Eisenmenger syndrome, Potts shunt, or atrial septostomy
- Unrepaired or residual cardiac shunt
- Diagnosis of pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or signs of capillary/venous involvement
- PAH related to portal hypertension
- Known visceral arteriovenous malformations in lung, liver, or brain
- History of full or partial pneumonectomy
- Untreated more than mild obstructive sleep apnea
- History of pericardial constriction
- Family history of sudden cardiac death or long QT syndrome
- Symptomatic coronary disease within 6 months before screening
- Stroke within 3 months before screening
- Prior exposure to sotatercept or luspatercept or allergy to their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)
Los Angeles, California, United States, 90095
Actively Recruiting
2
Stanford University School of Medicine ( Site 1603)
Palo Alto, California, United States, 94304
Actively Recruiting
3
UCSF Benioff Children's Hospital San Francisco ( Site 1611)
San Francisco, California, United States, 94158
Actively Recruiting
4
Children's Hospital Colorado ( Site 1609)
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Children's National Medical Center ( Site 1600)
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
6
Cincinnati Children's Hospital Medical Center ( Site 1602)
Cincinnati, Ohio, United States, 45229
Actively Recruiting
7
Children's Hospital of Philadelphia (CHOP) ( Site 1608)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
Monroe Carell Jr. Children's Hospital ( Site 1601)
Nashville, Tennessee, United States, 37232
Completed
9
Seattle Children's Hospital ( Site 1605)
Seattle, Washington, United States, 98105
Actively Recruiting
10
Children's Wisconsin ( Site 1610)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
11
The Children's Hospital at Westmead ( Site 0001)
Westmead, New South Wales, Australia, 2145
Actively Recruiting
12
Clinica Somer-Unidad de Investigacion y Docencia ( Site 0205)
Rionegro, Antioquia, Colombia, 054040
Actively Recruiting
13
Fundación Valle del Lili ( Site 0200)
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
14
Clínica Imbanaco S.A.S ( Site 0203)
Cali, Valle del Cauca Department, Colombia, 760042
Actively Recruiting
15
CHU de Toulouse - Hôpital des Enfants ( Site 0302)
Toulouse, Haute-Garonne, France, 31059
Actively Recruiting
16
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Actively Recruiting
17
Hôpital Universitaire Necker Enfants Malades ( Site 0300)
Paris, France, 75015
Actively Recruiting
18
Universitaetsklinikum Heidelberg ( Site 0401)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
19
Klinikum der Universität München Großhadern ( Site 0404)
München, Bavaria, Germany, 81337
Actively Recruiting
20
Medizinische Hochschule Hannover ( Site 0405)
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
21
Schneider Children's Medical Center ( Site 0603)
Petah Tikva, Israel, 4920235
Actively Recruiting
22
Sheba Medical Center ( Site 0601)
Ramat Gan, Israel, 5265601
Actively Recruiting
23
University Medical Center Groningen ( Site 0900)
Groningen, Netherlands, 9713 GZ
Actively Recruiting
24
Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)
Warsaw, Masovian Voivodeship, Poland, 04-730
Actively Recruiting
25
Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
26
Wits Clinical Research-Chris Hani Baragwanath Hospital ( Site 1201)
Johannesburg, Soweto, Gauteng, South Africa, 2013
Actively Recruiting
27
Hospital Universitario Ramón y Cajal ( Site 1300)
Madrid, Madrid, Comunidad de, Spain, 28034
Actively Recruiting
28
Hospital Universitari i Politecnic La Fe ( Site 1303)
Valencia, Valencia, Spain, 46026
Actively Recruiting
29
Hospital Universitari Vall d'Hebron ( Site 1302)
Barcelona, Spain, 08035
Actively Recruiting
30
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)
Madrid, Spain, 28007
Actively Recruiting
31
Hacettepe Universite Hastaneleri ( Site 1400)
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
32
Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim ( Site 1402)
Ankara, Turkey (Türkiye), 06560
Actively Recruiting
33
Ankara Bilkent Şehir Hastanesi. ( Site 1403)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
34
Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)
Istanbul, Turkey (Türkiye), 34303
Actively Recruiting
35
Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)
London, London, City of, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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