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RECRUITING
NCT07646860
PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

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.

Key Details

Gender

All

Age Range

1 Year - 17 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2026-09-17

Completion Date

2031-05-16

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

Sotatercept

Sotatercept subcutaneous injection every 3 weeks

Locations (3)

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

Izumi, Osaka, Japan

The University of Osaka Hospital ( Site 3201)

Suita, Osaka, Japan

National Center for Child Health and Development ( Site 3202)

Setagaya City, Tokyo, Japan