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An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.
LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
University of California San Diego Health ( Site 1002)
La Jolla, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
San Francisco, California, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
Torrance, California, United States
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States
Mayo Clinic Jacksonville ( Site 1045)
Jacksonville, Florida, United States
University of Kansas Medical Center ( Site 1020)
Kansas City, Kansas, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
Tufts Medical Center ( Site 1012)
Boston, Massachusetts, United States
Start Date
May 12, 2021
Primary Completion Date
December 7, 2028
Completion Date
December 7, 2028
Last Updated
March 9, 2026
815
ESTIMATED participants
Sotatercept
BIOLOGICAL
Lead Sponsor
Merck Sharp & Dohme LLC
NCT06649110
NCT06481852
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01347216