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A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
815
Start Date
2021-05-12
Completion Date
2028-12-07
Last Updated
2026-05-26
Healthy Volunteers
No
Conditions
Interventions
Sotatercept
Sotatercept SC injection every 3 weeks
Locations (115)
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
Arizona Pulmonary Specialists ( Site 1010)
Scottsdale, 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
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
Johns Hopkins University ( Site 1036)
Baltimore, Maryland, 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
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
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
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina
Instituto Médico Río Cuarto ( Site 1907)
Río Cuarto, Córdoba Province, Argentina
Sanatorio Parque ( Site 1905)
Rosario, Santa Fe Province, Argentina
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario, Santa Fe Province, Argentina
Hospital Provincial del Centenario ( Site 1912)
Rosario, Santa Fe Province, Argentina
Sanatorio Allende ( Site 1908)
Córdoba, Argentina
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
Santa Fe, Argentina
Royal Prince Alfred Hospital ( Site 1106)
Camperdown, New South Wales, Australia
The Prince Charles Hospital ( Site 1104)
Chermside, New South Wales, Australia
John Hunter Hospital ( Site 1101)
New Lambton Heights, New South Wales, Australia
Royal Hobart Hospital ( Site 1107)
Hobart, Tasmania, Australia
Fiona Stanley Hospital ( Site 1103)
Murdoch, Western Australia, Australia
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven ( Site 1401)
Leuven, Vlaams-Brabant, Belgium
Hospital Dia do Pulmao ( Site 1802)
Blumenau, Santa Catarina, Brazil
Peter Lougheed Centre ( Site 2102)
Calgary, Alberta, Canada
University of Alberta Hospital ( Site 2101)
Edmonton, Alberta, Canada
Fundación Neumológica Colombiana ( Site 3403)
Bogotá, Bogota D.C., Colombia
Clínica Imbanaco S.A.S ( Site 3404)
Cali, Valle del Cauca Department, Colombia
Klinicki Bolnicki Centar Split ( Site 3901)
Split, Split-Dalmatia County, Croatia
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
Prague, Praha 4, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2201)
Prague, Czechia
Rigshospitalet ( Site 3802)
København Ø, Capital Region, Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus, Central Jutland, Denmark
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
Nice, Alpes-Maritimes, France
CHU Bordeaux Haut-Leveque ( Site 1312)
Pessac, Aquitaine, France
Nouvel Hôpital Civil (NHC) ( Site 1307)
Strasbourg, Bas-Rhin, France
Hopital Cavale Blanche ( Site 1314)
Brest, Finistere, France
Hopital Larrey ( Site 1315)
Toulouse, Haute-Garonne, France
CHU de Grenoble Hopital Nord ( Site 1303)
La Tronche, Isere, France
Hopital Nord Laennec ( Site 1309)
Saint-Herblain, Loire-Atlantique, France
CHU Angers ( Site 1313)
Angers, Maine-et-Loire, France
CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE ( Site 1306)
Lille, Nord, France
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Hôpital Louis Pradel ( Site 1317)
Lyon, Rhone, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne, France
CHU de la Miletrie Poitiers ( Site 1316)
Poitiers, Vienne, France
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach ( Site 1510)
München, Bavaria, Germany
UKGM Gießen/Marburg ( Site 1512)
Giessen, Hesse, Germany
Medizinische Hochschule Hannover ( Site 1505)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Koeln ( Site 1511)
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig ( Site 1508)
Leipzig, Saxony, Germany
Universitätsklinikum Halle ( Site 1502)
Halle, Saxony-Anhalt, Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, Germany
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
Athens, Attica, Greece
Onassis Cardiac Surgery Center ( Site 3602)
Athens, Attica, Greece
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
Thessaloniki, Greece
Carmel Hospital ( Site 1705)
Haifa, Israel
Haddasah Medical Center ( Site 1711)
Jerusalem, Israel
Rabin Medical Center ( Site 1703)
Petah Tikva, Israel
Sheba Medical Center ( Site 1701)
Ramat Gan, Israel
Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)
Monza, Lombardy, Italy
Ospedale San Giuseppe ( Site 2403)
Milan, Milano, Italy
AOU Policlinico Umberto I ( Site 2402)
Rome, Roma, Italy
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)
Naples, Italy
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen, Gelderland, Netherlands
Amsterdam UMC, locatie VUmc ( Site 2601)
Amsterdam, North Holland, Netherlands
Waikato Hospital ( Site 2702)
Hamilton, Waikato Region, New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
Krakow, Lesser Poland Voivodeship, Poland
Hospital Garcia de Orta ( Site 3501)
Almada, Setúbal District, Portugal
Hospital Pulido Valente ( Site 3503)
Lisbon, Portugal
University Clinical Hospital Center of Serbia ( Site 2901)
Belgrade, Beograd, Serbia
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Novi Sad, Beograd, Serbia
Institute for Cardiovascular Diseases Dedinje ( Site 2903)
Belgrade, Serbia
Gachon University Gil Medical Center ( Site 3103)
Incheon, South Korea
Severance Hospital, Yonsei University Health System ( Site 3101)
Seoul, South Korea
Samsung Medical Center ( Site 3106)
Seoul, South Korea
Hospital Universitario de Son Espases ( Site 1611)
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander, Cantabria, Spain
Hospital Universitari Vall D Hebron ( Site 1605)
Barcelona, Catalonia, Spain
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
Majadahonda, Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid, Madrid, Comunidad de, Spain
Hospital Clinic de Barcelona ( Site 1602)
Barcelona, Spain
Hospital Universitario La Paz ( Site 1610)
Madrid, Spain
Hospital General Universitario Ramon y Cajal ( Site 1609)
Madrid, Spain
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
Toledo, Spain
Sahlgrenska Universitetssjukhuset ( Site 3201)
Gothenburg, Västra Götaland County, Sweden
UniversitätsSpital Zürich ( Site 3301)
Zurich, Switzerland
Kaohsiung Veteran General Hospital ( Site 3702)
Kaohsiung City, Taiwan
National Cheng Kung University Hospital ( Site 3703)
Tainan, Taiwan
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambridge, Cambridgeshire, United Kingdom
Golden Jubilee National Hospital ( Site 1204)
Glasgow, Glasgow City, United Kingdom
Royal Free Hospital ( Site 1202)
London, London, City of, United Kingdom
Royal Brompton Hospital ( Site 1206)
London, London, City of, United Kingdom
Hammersmith Hospital ( Site 1203)
London, London, City of, United Kingdom
Freeman Hospital ( Site 1205)
Newcastle upon Tyne, United Kingdom
Royal Hallamshire Hospital ( Site 1207)
Sheffield, United Kingdom