A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Recruiting · NCT07218029 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 20 US states.
- Pulmonary Associates, PA ( Site 1008) - Phoenix, Arizona, United States
- Arizona Pulmonary Specialists ( Site 1010) - Scottsdale, Arizona, United States
- University of Arizona ( Site 1006) - Tucson, Arizona, United States
- University of California San Diego Health ( Site 1002) - La Jolla, California, United States
- UC Irvine Health Medical Center ( Site 1086) - Orange, California, United States
- UC Davis - Medial Center ( Site 1064) - Sacramento, 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
- George Washington University Medical Faculty Associates ( Site 1025) - Washington D.C., District of Columbia, United States
- Mayo Clinic Jacksonville ( Site 1045) - Jacksonville, Florida, United States
- AdventHealth Orlando ( Site 1058) - Orlando, Florida, United States
- Tampa General Hospital ( Site 1043) - Tampa, Florida, United States
- University of Kansas Medical Center ( Site 1020) - Kansas City, Kansas, United States
- Norton Pulmonary Specialists ( Site 1066) - Louisville, Kentucky, United States
- Johns Hopkins University ( Site 1036) - Baltimore, Maryland, United States
- Tufts Medical Center ( Site 1012) - Boston, Massachusetts, United States
- Brigham and Women's Hospital ( Site 1014) - Boston, Massachusetts, United States
- University of Minnesota ( Site 1062) - Minneapolis, Minnesota, 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
- Duke University Medical Center ( Site 1026) - Durham, North Carolina, 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
- Cleveland Clinic Main ( Site 1065) - Cleveland, 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
- University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059) - Pittsburgh, Pennsylvania, United States
- Rhode Island Hospital ( Site 1033) - Providence, Rhode Island, United States
- Medical University of South Carolina ( Site 1003) - Charleston, South Carolina, United States
- University of Texas Southwestern Medical Center ( Site 1038) - Dallas, Texas, United States
- CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044) - Houston, Texas, United States
- Houston Methodist Hospital ( Site 1009) - Houston, Texas, United States
- Froedtert Hospital & the Medical College of Wisconsin ( Site 1051) - Milwaukee, Wisconsin, United States
- Hospital Clinic de Barcelona ( Site 1602) - Barcelona, Spain
- Institute for Cardiovascular Diseases Dedinje ( Site 2903) - Belgrade, Serbia
- DRK Kliniken Berlin Westend ( Site 1507) - Berlin, Germany
- Sanatorio Allende ( Site 1908) - Córdoba, Argentina
- Carmel Hospital ( Site 1705) - Haifa, Israel
- Gachon University Gil Medical Center ( Site 3103) - Incheon, South Korea
- Haddasah Medical Center ( Site 1711) - Jerusalem, Israel
- Kaohsiung Veteran General Hospital ( Site 3702) - Kaohsiung City, Taiwan
- Meir Medical Center ( Site 1707) - Kfar Saba, Israel
- Hospital Pulido Valente ( Site 3503) - Lisbon, Portugal
- Hospital Universitario La Paz ( Site 1610) - Madrid, Spain
- Hospital General Universitario Ramon y Cajal ( Site 1609) - Madrid, Spain
- A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407) - Naples, Italy
- Freeman Hospital ( Site 1205) - Newcastle upon Tyne, United Kingdom
- Rabin Medical Center ( Site 1703) - Petah Tikva, Israel
- Vseobecna fakultni nemocnice v Praze ( Site 2201) - Prague, Czechia
- Sheba Medical Center ( Site 1701) - Ramat Gan, Israel
- Hospital Provincial Dr. Jose M. Cullen ( Site 1902) - Santa Fe, Argentina
- Severance Hospital, Yonsei University Health System ( Site 3101) - Seoul, South Korea
- Samsung Medical Center ( Site 3106) - Seoul, South Korea
- Royal Hallamshire Hospital ( Site 1207) - Sheffield, United Kingdom
- Instituto do Coracao - HCFMUSP ( Site 1803) - São Paulo, Brazil
- National Cheng Kung University Hospital ( Site 3703) - Tainan, Taiwan
- AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601) - Thessaloniki, Greece
- HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607) - Toledo, Spain
Showing 60 of 135 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →