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A Study of Sotatercept in Japanese Pulmonary Arterial Hypertension (PAH) Participants (MK-7962-020)
Sponsor: Merck Sharp & Dohme LLC
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
Conditions
Interventions
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