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Not yet recruiting NCT07646860

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

Phase II Interventional Pulmonary Arterial Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sotatercept.
Who it may be relevant to
Registry conditions: Pulmonary Arterial Hypertension. Basic parameters: 1 year — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Biological Sotatercept
    Sotatercept subcutaneous injection every 3 weeks

Primary outcome measures

  • Number of Participants With One or More Adverse Events [Time frame: Up to approximately 24 weeks]
  • Number of Participants Who Discontinue Study Intervention Due to an Adverse Event [Time frame: Up to approximately 24 weeks]
  • Laboratory Parameter (Hematology): Concentration of Hemoglobin [Time frame: Up to approximately 24 weeks]
  • Laboratory Parameter (Hematology): Hematocrit [Time frame: Up to approximately 24 weeks]
  • Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count [Time frame: Up to approximately 24 weeks]
  • Laboratory Parameter (Hematology): Reticulocyte Count [Time frame: Up to approximately 24 weeks]
  • Laboratory Parameter (Hematology): Platelet Count [Time frame: Up to approximately 24 weeks]
  • Blood Pressure (BP) [Time frame: Up to approximately 24 weeks]
  • Number of Participants with Detectable Anti-Drug Antibodies (ADAs) [Time frame: Up to approximately 24 weeks]
  • Number of Participants with Detectable Neutralizing Antibodies to Sotatercept [Time frame: Up to approximately 24 weeks]
Secondary outcome measures (12)
  • Mean Change from Baseline in 6-Minute Walk Distance (6MWD) [Time frame: Baseline and Week 24]
  • Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP) [Time frame: Baseline and Week 24]
  • Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC) [Time frame: Baseline and Week 24]
  • Number of Participants With One or More Adverse Events [Time frame: From Week 24 up to approximately 58 months]
  • Number of Participants Who Discontinue Study Intervention Due to an Adverse Event [Time frame: From Week 24 up to approximately 58 months]
  • Laboratory Parameter (Hematology): Concentration of Hemoglobin [Time frame: From Week 24 up to approximately 58 months]
  • Laboratory Parameter (Hematology): Hematocrit [Time frame: From Week 24 up to approximately 58 months]
  • Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count [Time frame: From Week 24 up to approximately 58 months]
  • Laboratory Parameter (Hematology): Reticulocyte Count [Time frame: From Week 24 up to approximately 58 months]
  • Laboratory Parameter (Hematology): Platelet Count [Time frame: From Week 24 up to approximately 58 months]
  • Blood Pressure (BP) [Time frame: From Week 24 up to approximately 58 months]
  • Number of Participants with Detectable ADAs [Time frame: From Week 24 up to approximately 58 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07646860 · 7962-032 · MK-7962-032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗