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)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The main inclusion criteria include but are not limited to the following:

• Has completed the MK-7962-004 study requirements

• Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements

Locations
United States
Arizona
Pulmonary Associates, PA ( Site 1008)
RECRUITING
Phoenix
California
University of California San Diego Health ( Site 1002)
RECRUITING
La Jolla
Colorado
University of Colorado Hospital ( Site 1013)
RECRUITING
Aurora
New York
Weill Cornell Medical Center ( Site 1046)
RECRUITING
New York
Ohio
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
RECRUITING
Cincinnati
Other Locations
United Kingdom
Hammersmith Hospital ( Site 1203)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2028-12-07
Participants
Target number of participants: 815
Treatments
Experimental: Sotatercept
Participants enrolling from the MK-7962-004 sotatercept study will continue sotatercept at their current dose. If currently at a dose \<0.7 mg/kg subcutaneous (SC) injection, participants can titrate up to 0.7 mg/kg SC injection for the remainder of this study.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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