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COMPLETED
NCT05818137
PHASE3

A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This local Phase 3 study is planned to confirm the efficacy and safety in Japanese PAH participants. The primary population of this study is Japanese PAH participants with World Health Organization Functional Class (WHO FC) II or III while the study includes PAH participants with WHO FC I or IV as other populations. There are no hypotheses for this study.

Official title: A Phase 3 Non-randomized, Non-controlled, Open Label Clinical Study to Evaluate the Efficacy and Safety of MK-7962 (Sotatercept) add-on to Background Therapy in Japanese Participants With Pulmonary Arterial Hypertension (PAH)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2023-05-10

Completion Date

2025-11-06

Last Updated

2026-06-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Sotatercept

SC injection at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 21 days plus background PAH therapy.

Locations (17)

Nagoya University Hospital ( Site 2010)

Nagoya, Aichi-ken, Japan

Chiba Saiseikai Narashino hospital ( Site 2004)

Narashino, Chiba, Japan

Kurume University Hospital ( Site 2014)

Kurume, Fukuoka, Japan

Kure Kyosai Hospital ( Site 2017)

Kure, Hiroshima, Japan

Sapporo Medical University Hospital ( Site 2018)

Sapporo, Hokkaido, Japan

Hokkaido University Hospital ( Site 2001)

Sapporo, Hokkaido, Japan

Kobe University Hospital ( Site 2012)

Kobe, Hyōgo, Japan

Tohoku University Hospital ( Site 2002)

Sendai, Miyagi, Japan

National Cerebral and Cardiovascular Center ( Site 2011)

Suita, Osaka, Japan

Hamamatsu University Hospital ( Site 2016)

Hamamatsu, Shizuoka, Japan

The University of Tokyo Hospital ( Site 2006)

Bunkyo-ku, Tokyo, Japan

Kyorin University Hospital ( Site 2005)

Mitaka, Tokyo, Japan

Chiba University Hospital ( Site 2003)

Chiba, Japan

Kyushu University Hospital ( Site 2015)

Fukuoka, Japan

National Hospital Organization Okayama Medical Center ( Site 2013)

Okayama, Japan

International University of Health and Welfare Mita Hospital ( Site 2008)

Tokyo, Japan

Keio university hospital ( Site 2007)

Tokyo, Japan