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RECRUITINGPhase 3INTERVENTIONAL

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: The main inclusion criteria include but are not limited to the following: - Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early - Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements - Must have the ability to understand and provide documented willing to sign a consent form Who Should NOT Join This Trial: The main exclusion criteria include but are not limited to the following: - Did not participate in a sotatercept PAH parent study - Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study. - Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept - Is a female who is pregnant or breastfeeding - Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study - Is currently enrolled in another investigational product study other than a sotatercept study - Is incapacitated Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early * Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements * Must have the ability to understand and provide documented informed consent Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Did not participate in a sotatercept PAH parent study * Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study. * Presence of an ongoing serious adverse event that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept * Is a female who is pregnant or breastfeeding * Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study * Is currently enrolled in another investigational product study other than a sotatercept study * Is incapacitated

Treatments Being Tested

BIOLOGICAL

Sotatercept

Sotatercept SC injection every 3 weeks

Locations (20)

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
AdventHealth Orlando ( Site 1058)
Orlando, 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
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
University of Cincinnati Medical Center ( Site 1035)
Cincinnati, Ohio, United States
Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States
Oregon Health & Science University ( Site 1054)
Portland, Oregon, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
Houston, Texas, United States
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina
Instituto Médico Río Cuarto ( Site 1907)
Río Cuarto, Córdoba Province, Argentina