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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05587712
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Merck Sharp & Dohme LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Medical Director
Principal Investigator Affiliation Merck Sharp & Dohme LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Colombia, France, Germany, Israel, Netherlands, Poland, Spain, Turkey, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: 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.

Interventions

Drug: - Sotatercept

SC injection every 3 weeks (Q3W) of 0.3 mg/kg. Dosage may be adjusted based on protocol-specific guidelines.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Recruiting

Address

The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 1606)

Los Angeles, California, 90095

Site Contact

Study Coordinator

Trialsites@merck.com

310-505-0088

Palo Alto, California

Status

Recruiting

Address

Stanford University School of Medicine ( Site 1603)

Palo Alto, California, 94304

Site Contact

Study Coordinator

Trialsites@merck.com

267-398-3637

San Francisco, California

Status

Recruiting

Address

UCSF Benioff Children's Hospital San Francisco ( Site 1611)

San Francisco, California, 94158

Site Contact

Study Coordinator

Trialsites@merck.com

415-476-6795

Aurora, Colorado

Status

Recruiting

Address

Children's Hospital Colorado ( Site 1609)

Aurora, Colorado, 80045

Site Contact

Study Coordinator

Trialsites@merck.com

303-921-4811

Washington, District of Columbia

Status

Recruiting

Address

Children's National Medical Center ( Site 1600)

Washington, District of Columbia, 20010

Site Contact

Study Coordinator

Trialsites@merck.com

202-476-2130

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center ( Site 1602)

Cincinnati, Ohio, 45245

Site Contact

Study Coordinator

Trialsites@merck.com

513-636-7072

Nashville, Tennessee

Status

Recruiting

Address

Monroe Carell Jr. Children's Hospital ( Site 1601)

Nashville, Tennessee, 37232

Site Contact

Study Coordinator

Trialsites@merck.com

615-875-6901

Seattle Children's Hospital ( Site 1605), Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital ( Site 1605)

Seattle, Washington, 98105

Site Contact

Study Coordinator

Trialsites@merck.com

206-877-2219

International Sites

Westmead, New South Wales, Australia

Status

Recruiting

Address

The Children's Hospital at Westmead ( Site 0001)

Westmead, New South Wales, 2145

Site Contact

Study Coordinator

Trialsites@merck.com

0298452345

Fundación Valle del Lili ( Site 0200), Cali, Valle Del Cauca, Colombia

Status

Recruiting

Address

Fundación Valle del Lili ( Site 0200)

Cali, Valle Del Cauca, 760032

Site Contact

Study Coordinator

Trialsites@merck.com

3165212877

Clínica Imbanaco S.A.S ( Site 0203), Cali, Valle Del Cauca, Colombia

Status

Recruiting

Address

Clínica Imbanaco S.A.S ( Site 0203)

Cali, Valle Del Cauca, 760042

Site Contact

Study Coordinator

Trialsites@merck.com

+57 301 6613144

Toulouse, Haute-Garonne, France

Status

Recruiting

Address

CHU de Toulouse - Hôpital des Enfants ( Site 0302)

Toulouse, Haute-Garonne, 31059

Site Contact

Study Coordinator

Trialsites@merck.com

05345558596

Marseille, Provence-Alpes-Cote-d Azur, France

Status

Recruiting

Address

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone ( Site 0303)

Marseille, Provence-Alpes-Cote-d Azur, 13005

Site Contact

Study Coordinator

Trialsites@merck.com

+334 91 38 67 50

Paris, France

Status

Recruiting

Address

Hôpital Universitaire Necker Enfants Malades ( Site 0300)

Paris, , 75015

Site Contact

Study Coordinator

Trialsites@merck.com

33679166652

Heidelberg, Baden-Wurttemberg, Germany

Status

Recruiting

Address

Universitaetsklinikum Heidelberg ( Site 0401)

Heidelberg, Baden-Wurttemberg, 69120

Site Contact

Study Coordinator

Trialsites@merck.com

+496221564606

München, Bayern, Germany

Status

Recruiting

Address

Klinikum der Universität München Großhadern ( Site 0404)

München, Bayern, 81337

Site Contact

Study Coordinator

Trialsites@merck.com

004989440073941

Hannover, Niedersachsen, Germany

Status

Recruiting

Address

Medizinische Hochschule Hannover ( Site 0405)

Hannover, Niedersachsen, 30625

Site Contact

Study Coordinator

Trialsites@merck.com

0049 511 532 9041

Petah-Tikva, Israel

Status

Recruiting

Address

Schneider Children's Medical Center ( Site 0603)

Petah-Tikva, , 49202

Site Contact

Study Coordinator

Trialsites@merck.com

050-4057131

Sheba Medical Center ( Site 0601), Ramat Gan, Israel

Status

Recruiting

Address

Sheba Medical Center ( Site 0601)

Ramat Gan, , 5265601

Site Contact

Study Coordinator

Trialsites@merck.com

972 0526667332

Groningen, Netherlands

Status

Recruiting

Address

University Medical Center Groningen ( Site 0900)

Groningen, , 9700RB

Site Contact

Study Coordinator

Trialsites@merck.com

31505612800

Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Centrum Zdrowia Dziecka w Warszawie-Klinika Kardiologii ( Site 1103)

Warszawa, Mazowieckie, 04-730

Site Contact

Study Coordinator

Trialsites@merck.com

+48228157370

Gdańsk, Pomorskie, Poland

Status

Recruiting

Address

Uniwersyteckie Centrum Kliniczne-Klinika Kardiologii Dziecięcej i Wad Wrodzonych Serca ( Site 1102)

Gdańsk, Pomorskie, 80-952

Site Contact

Study Coordinator

Trialsites@merck.com

+48695687587

Madrid, Madrid, Comunidad De, Spain

Status

Recruiting

Address

Hospital Universitario Ramón y Cajal ( Site 1300)

Madrid, Madrid, Comunidad De, 28034

Site Contact

Study Coordinator

Trialsites@merck.com

+34 913 36 80 00

València, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe ( Site 1303)

València, Valencia, 46026

Site Contact

Study Coordinator

Trialsites@merck.com

699 449 273

Barcelona, Spain

Status

Recruiting

Address

Hospital Universitari Vall d'Hebron ( Site 1302)

Barcelona, , 08035

Site Contact

Study Coordinator

Trialsites@merck.com

626774330

Madrid, Spain

Status

Recruiting

Address

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1301)

Madrid, , 28007

Site Contact

Study Coordinator

Trialsites@merck.com

+34 915 86 80 00

Ankara, Turkey

Status

Recruiting

Address

Hacettepe Universite Hastaneleri ( Site 1400)

Ankara, , 06100

Site Contact

Study Coordinator

Trialsites@merck.com

05325503041

Ankara, Turkey

Status

Recruiting

Address

Gazi University Health Research and Application Center Gazi -Çocuk Sağlığı ve Hastalıkları Anabilim

Ankara, , 06560

Site Contact

Study Coordinator

Trialsites@merck.com

05553684926

Ankara, Turkey

Status

Recruiting

Address

Ankara Bilkent Şehir Hastanesi. ( Site 1403)

Ankara, , 06800

Site Contact

Study Coordinator

Trialsites@merck.com

+905053166839

Istanbul, Turkey

Status

Recruiting

Address

Mehmet Akif Ersoy Research and Training Hospital ( Site 1404)

Istanbul, , 34303

Site Contact

Study Coordinator

Trialsites@merck.com

+905422560601

London, London, City Of, United Kingdom

Status

Recruiting

Address

Great Ormond Street Hospital For Children NHS Foundation Trust ( Site 1500)

London, London, City Of, WC1N 3JH

Site Contact

Study Coordinator

Trialsites@merck.com

02074059200

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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