Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

A Study of Sotatercept (MK-7962) in Japanese Children With Pulmonary Arterial Hypertension (PAH) (MK-7962-032)

7 september 2026 bijgewerkt door: Merck Sharp & Dohme LLC

A Phase 2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotatercept (MK-7962) in Japanese Children From 1 to Less Than 18 Years of Age With PAH on Standard of Care.

The goal of this study is to learn about the safety of sotatercept and how well Japanese children tolerate it, when taken along with standard (usual) pulmonary arterial hypertension (PAH) treatment. Researchers also want to learn what happens to it in a person's body over time and whether it lowers resistance in blood vessels in the lungs.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

6

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Japan
    • Osaka
      • Izumi, Osaka, Japan, 594-1101
        • Werving
        • Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-725-56-1260
      • Suita, Osaka, Japan, 565-0871
        • Werving
        • The University of Osaka Hospital ( Site 3201)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-6-6879-5111
    • Tokyo
      • Setagaya City, Tokyo, Japan, 157-8535
        • Werving
        • National Center for Child Health and Development ( Site 3202)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +81-3-3416-0181

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has pulmonary arterial hypertension (PAH, World Health Organization Group 1) confirmed by a prior right heart catheterization
  • Has idiopathic, heritable, drug- or toxin-induced PAH, connective tissue disease-associated PAH, repaired congenital heart disease-associated PAH, or PAH with coincidental shunt
  • Has PAH classified as World Health Organization Functional Class I, or symptomatic World Health Organization Functional Class II to IV
  • Has been receiving stable standard-of-care background therapy for PAH for at least 90 days
  • Is Japanese

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of left-sided heart disease
  • Has severe congenital or developmental abnormalities of the lung, thorax, and/or diaphragm
  • History of Eisenmenger syndrome, Potts shunt, or recent atrial septostomy within 180 days
  • Has unrepaired or residual cardiac shunt with Qp/Qs >1.5
  • Has pulmonary veno-occlusive disease, pulmonary capillary hemangiomatosis, or overt signs of pulmonary capillary and/or venous involvement
  • PAH associated with portal hypertension
  • Known visceral arteriovenous malformations
  • 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
  • History of symptomatic coronary disease within 6 months or cerebrovascular accident within 3 months
  • Prior treatment with sotatercept or luspatercept

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Sotatercept
Participants receive sotatercept by subcutaneous injection every 3 weeks (Q3W) for up to approximately 24 weeks while continuing standard-of-care background therapy for PAH. Participants start at a dose of 0.3 mg/kg Q3W, and may titrate up to the target dose of 0.7 mg/kg SC injection Q3W starting at Week 6 based on protocol-defined dose-escalation guidance. After Week 24, participants who meet certain requirements may choose to continue receiving sotatercept for up to 58 months.
Biologisch: Sotatercept
Sotatercept subcutaneous injection every 3 weeks
Andere namen:
  • ACE-011
  • MK-7962
  • ActRIIA-IgG1Fc
  • WINREVAIR®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Participants With One or More Adverse Events
Tijdsspanne: Up to approximately 24 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 24 weeks
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Tijdsspanne: Up to approximately 24 weeks
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Tijdsspanne: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Hematocrit
Tijdsspanne: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Tijdsspanne: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Reticulocyte Count
Tijdsspanne: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
Up to approximately 24 weeks
Laboratory Parameter (Hematology): Platelet Count
Tijdsspanne: Up to approximately 24 weeks
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
Up to approximately 24 weeks
Blood Pressure (BP)
Tijdsspanne: Up to approximately 24 weeks
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
Up to approximately 24 weeks
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Tijdsspanne: Up to approximately 24 weeks
Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented.
Up to approximately 24 weeks
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Tijdsspanne: Up to approximately 24 weeks
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as antidrug antibody-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
Up to approximately 24 weeks
Serum Trough Concentration (Ctrough) of Sotatercept
Tijdsspanne: At designated time points and up to approximately 24 weeks
Serum samples collected predose will be used to determine serum trough concentration (Ctrough) of sotatercept.
At designated time points and up to approximately 24 weeks
Change From Baseline in Pulmonary Vascular Resistance Index (PVRI)
Tijdsspanne: Baseline and Week 24
The change from baseline in PVRI will be presented.
Baseline and Week 24

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gemiddelde verandering ten opzichte van baseline in N-terminaal prohormoon B-type natriuretisch peptide (NT-proBNP)
Tijdsspanne: Basislijn en week 24
De verandering ten opzichte van de uitgangswaarde in plasma NT-proBNP-spiegels zal worden gerapporteerd.
Basislijn en week 24
Percentage deelnemers dat hun functionele klasse van de Wereldgezondheidsorganisatie (WHO FC) heeft verbeterd of behouden
Tijdsspanne: Basislijn en week 24
De ernst van de PAH-symptomen van een persoon wordt beoordeeld met behulp van het WHO FC-systeem. De WHO functionele classificatie voor PAH varieert van Klasse I (geen beperking in fysieke activiteit, geen kortademigheid bij normale activiteit), Klasse II (lichte beperking van fysieke activiteit), Klasse III (duidelijke beperking van fysieke activiteit) en Klasse IV (kan geen fysieke activiteit uitvoeren). activiteit zonder symptomen, kortademigheid in rust). De wijziging ten opzichte van de uitgangswaarde in WHO FC wordt ingedeeld in "Verbeterd", "Geen wijziging" en "Verslechterd". Verbetering = afname van FC, verslechtering = toename van FC en geen verandering = geen verandering van FC.
Basislijn en week 24
Mean Change from Baseline in 6-Minute Walk Distance (6MWD)
Tijdsspanne: Baseline and Week 24
6MWD will be assessed using the 6-minute walk test (6MWT).
Baseline and Week 24
Number of Participants With One or More Adverse Events
Tijdsspanne: From Week 24 up to approximately 58 months
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
From Week 24 up to approximately 58 months
Number of Participants Who Discontinue Study Intervention Due to an Adverse Event
Tijdsspanne: From Week 24 up to approximately 58 months
An adverse event is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Concentration of Hemoglobin
Tijdsspanne: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The concentration of hemoglobin will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Hematocrit
Tijdsspanne: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The hematocrit will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count
Tijdsspanne: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The RBC count will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Reticulocyte Count
Tijdsspanne: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The reticulocyte count will be presented.
From Week 24 up to approximately 58 months
Laboratory Parameter (Hematology): Platelet Count
Tijdsspanne: From Week 24 up to approximately 58 months
Hematological parameters will be investigated in blood samples from participants by means of clinical laboratory assays and evaluated by the investigator. The platelet count will be presented.
From Week 24 up to approximately 58 months
Blood Pressure (BP)
Tijdsspanne: From Week 24 up to approximately 58 months
BP will be assessed while the participant was seated after a period of rest in a quiet setting with no distractions (eg, television and cell phones).
From Week 24 up to approximately 58 months
Number of Participants with Detectable ADAs
Tijdsspanne: From Week 24 up to approximately 58 months
Blood samples will be collected to assess antidrug antibodies to sotatercept. The number of participants with detectable ADAs at any time during the study will be presented.
From Week 24 up to approximately 58 months
Number of Participants with Detectable Neutralizing Antibodies to Sotatercept
Tijdsspanne: From Week 24 up to approximately 58 months
Neutralizing antibody analysis will be performed on blood samples for participants who are confirmed as ADA-positive. The number of participants with detectable neutralizing antibodies at any time during the study will be presented.
From Week 24 up to approximately 58 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

25 september 2026

Primaire voltooiing (Geschat)

24 mei 2029

Studie voltooiing (Geschat)

16 mei 2031

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2026

Eerst geplaatst (Werkelijk)

15 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 september 2026

Laatste update ingediend die voldeed aan QC-criteria

7 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 7962-032
  • MK-7962-032 (Andere identificatie: MSD)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren