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

Phase 2RecruitingNCT07646860

Merck Sharp & Dohme LLC6 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Arterial Hypertension

Interventions

SotaterceptBIOLOGICAL

Sotatercept subcutaneous injection every 3 weeks

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (3)

Osaka Prefectural Hospital Organization Osaka Women's and Children's Hospital ( Site 3203)

Izumi, Osaka, Japan

RECRUITING

The University of Osaka Hospital ( Site 3201)

Suita, Osaka, Japan

RECRUITING

National Center for Child Health and Development ( Site 3202)

Setagaya City, Tokyo, Japan

RECRUITING

Outcomes

Primary Outcomes

Number of Participants With One or More Adverse Events

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.

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

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.

Time frame: Up to approximately 24 weeks

Laboratory Parameter (Hematology): Hematocrit

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.

Time frame: Up to approximately 24 weeks

Laboratory Parameter (Hematology): Red Blood Cell (RBC) Count

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.

Time frame: Up to approximately 24 weeks

Laboratory Parameter (Hematology): Reticulocyte Count

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.

Central Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@merck.com

Data from ClinicalTrials.gov

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Secondary Outcomes

Mean Change from Baseline in 6-Minute Walk Distance (6MWD)

6MWD will be assessed using the 6-minute walk test (6MWT).

Time frame: Baseline and Week 24

Mean Change from Baseline in N-terminal Prohormone B-type Natriuretic Peptide (NT-proBNP)

The change from baseline in plasma NT-proBNP levels will be reported.

Time frame: Baseline and Week 24

Percentage of Participants Who Either Improved or Maintained Their World Health Organization Functional Class (WHO FC)

The severity of an individual's PAH symptoms will be graded using the WHO FC system. WHO functional classification for PAH range from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). The change from baseline in WHO FC will be classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC.

Time frame: Baseline and Week 24

Number of Participants With One or More Adverse Events