A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)
Start Date
5/12/2021
Completion Date
12/7/2028
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Sotatercept
Conditions
Locations
Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona 85032
United States
Arizona Pulmonary Specialists ( Site 1010)
Scottsdale, Arizona 85258
United States
University of Arizona ( Site 1006)
Tucson, Arizona 85724-0001
United States
University of California San Diego Health ( Site 1002)
La Jolla, California 92039
United States
UC Irvine Health Medical Center ( Site 1086)
Orange, California 92868
United States
UC Davis - Medial Center ( Site 1064)
Sacramento, California 95817
United States
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
San Francisco, California 94143
United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara, California 93105-5316
United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
Torrance, California 90502
United States
University of Colorado Hospital ( Site 1013)
Aurora, Colorado 80045
United States
George Washington University Medical Faculty Associates ( Site 1025)
Washington D.C., District of Columbia 20037
United States
Mayo Clinic Jacksonville ( Site 1045)
Jacksonville, Florida 32224
United States
AdventHealth Orlando ( Site 1058)
Orlando, Florida 32803
United States
Tampa General Hospital ( Site 1043)
Tampa, Florida 33606
United States
University of Kansas Medical Center ( Site 1020)
Kansas City, Kansas 66160
United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky 40202
United States
Johns Hopkins University ( Site 1036)
Baltimore, Maryland 21287
United States
Tufts Medical Center ( Site 1012)
Boston, Massachusetts 02111
United States
Brigham and Women's Hospital ( Site 1014)
Boston, Massachusetts 02115
United States
University of Minnesota ( Site 1062)
Minneapolis, Minnesota 55455
United States
University Of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska 68198-5990
United States
Weill Cornell Medical Center ( Site 1046)
New York, New York 10021
United States
Duke University Medical Center ( Site 1026)
Durham, North Carolina 27710-4000
United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati, Ohio 45219
United States
University of Cincinnati Medical Center ( Site 1035)
Cincinnati, Ohio 45219
United States
Cleveland Clinic Main ( Site 1065)
Cleveland, Ohio 44195
United States
Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio 43210
United States
Oregon Health & Science University ( Site 1054)
Portland, Oregon 97239
United States
University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059)
Pittsburgh, Pennsylvania 15213
United States
Rhode Island Hospital ( Site 1033)
Providence, Rhode Island 02903
United States
Medical University of South Carolina ( Site 1003)
Charleston, South Carolina 29425
United States
University of Texas Southwestern Medical Center ( Site 1038)
Dallas, Texas 75390
United States
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
Houston, Texas 77030
United States
Houston Methodist Hospital ( Site 1009)
Houston, Texas 77030
United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
Milwaukee, Wisconsin 53226
United States
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires B1878GEG
Argentina
Instituto Médico Río Cuarto ( Site 1907)
Río Cuarto, Córdoba Province X5800AEV
Argentina
Sanatorio Parque ( Site 1905)
Rosario, Santa Fe Province S2000CUB
Argentina
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario, Santa Fe Province S2000DSR
Argentina
Hospital Provincial del Centenario ( Site 1912)
Rosario, Santa Fe Province S2002KDS
Argentina
Sanatorio Allende ( Site 1908)
Córdoba, X5021FPQ
Argentina
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
Santa Fe, S3000EOZ
Argentina
Royal Prince Alfred Hospital ( Site 1106)
Camperdown, New South Wales 2050
Australia
The Prince Charles Hospital ( Site 1104)
Chermside, New South Wales 4032
Australia
John Hunter Hospital ( Site 1101)
New Lambton Heights, New South Wales 2305
Australia
Royal Adelaide Hospital ( Site 1109)
Adelaide, South Australia 5000
Australia
Royal Hobart Hospital ( Site 1107)
Hobart, Tasmania 7000
Australia
Fiona Stanley Hospital ( Site 1103)
Murdoch, Western Australia 6150
Australia
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
Brussels, Bruxelles-Capitale, Region de 1070
Belgium
UZ Leuven ( Site 1401)
Leuven, Vlaams-Brabant 3000
Belgium
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)
Porto Alegre, Rio Grande do Sul 90020-090
Brazil
Hospital Dia do Pulmao ( Site 1802)
Blumenau, Santa Catarina 89010-000
Brazil
Instituto do Coracao - HCFMUSP ( Site 1803)
São Paulo, 05403-000
Brazil
Peter Lougheed Centre ( Site 2102)
Calgary, Alberta T1Y 6J4
Canada
University of Alberta Hospital ( Site 2101)
Edmonton, Alberta T6G 2B7
Canada
Fundación Neumológica Colombiana ( Site 3403)
Bogotá, Bogota D.C. 110131
Colombia
Clínica Imbanaco S.A.S ( Site 3404)
Cali, Valle del Cauca Department 760042
Colombia
Klinicki Bolnicki Centar Split ( Site 3901)
Split, Split-Dalmatia County 21000
Croatia
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
Prague, Praha 4 140 21
Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2201)
Prague, 128 08
Czechia
Rigshospitalet ( Site 3802)
København Ø, Capital Region 2100
Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus, Central Jutland 8200
Denmark
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
Nice, Alpes-Maritimes 06300
France
CHU Bordeaux Haut-Leveque ( Site 1312)
Pessac, Aquitaine 33604
France
Nouvel Hôpital Civil (NHC) ( Site 1307)
Strasbourg, Bas-Rhin 67000
France
Hopital Cavale Blanche ( Site 1314)
Brest, Finistere 29609
France
Hopital Larrey ( Site 1315)
Toulouse, Haute-Garonne 31400
France
CHU de Grenoble Hopital Nord ( Site 1303)
La Tronche, Isere 38700
France
Hopital Nord Laennec ( Site 1309)
Saint-Herblain, Loire-Atlantique 44800
France
CHU Angers ( Site 1313)
Angers, Maine-et-Loire 49100
France
CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE ( Site 1306)
Lille, Nord 59037
France
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
Saint-Étienne-de-Montluc, Pays de la Loire Region 42055
France
Hôpital Louis Pradel ( Site 1317)
Lyon, Rhone 69677
France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne 94275
France
CHU de la Miletrie Poitiers ( Site 1316)
Poitiers, Vienne 86021
France
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
Heidelberg, Baden-Wurttemberg 69126
Germany
Krankenhaus Neuwittelsbach ( Site 1510)
München, Bavaria 80639
Germany
Universitaetsklinik Regensburg ( Site 1503)
Regensburg, Bavaria 93053
Germany
UKGM Gießen/Marburg ( Site 1512)
Giessen, Hesse 35392
Germany
Medizinische Hochschule Hannover ( Site 1505)
Hanover, Lower Saxony 30625
Germany
Universitaetsklinikum Koeln ( Site 1511)
Cologne, North Rhine-Westphalia 50937
Germany
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
Dresden, Saxony 01307
Germany
Universitätsklinikum Leipzig ( Site 1508)
Leipzig, Saxony 04103
Germany
Universitätsklinikum Halle ( Site 1502)
Halle, Saxony-Anhalt 06120
Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, 14050
Germany
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
Athens, Attica 124 62
Greece
Onassis Cardiac Surgery Center ( Site 3602)
Athens, Attica 176 74
Greece
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
Thessaloniki, 546 36
Greece
Carmel Hospital ( Site 1705)
Haifa, 3436212
Israel
Haddasah Medical Center ( Site 1711)
Jerusalem, 9112001
Israel
Rabin Medical Center ( Site 1703)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 1701)
Ramat Gan, 5265601
Israel
Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)
Monza, Lombardy 20900
Italy
Ospedale San Giuseppe ( Site 2403)
Milan, Milano 20123
Italy
AOU Policlinico Umberto I ( Site 2402)
Rome, Roma 00161
Italy
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)
Naples, 80131
Italy
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen, Gelderland 6525 GA
Netherlands
Amsterdam UMC, locatie VUmc ( Site 2601)
Amsterdam, North Holland 1081 HV
Netherlands
Waikato Hospital ( Site 2702)
Hamilton, Waikato Region 3240
New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
Krakow, Lesser Poland Voivodeship 31-202
Poland
Europejskie Centrum Zdrowia Otwock ( Site 2802)
Otwock, Masovian Voivodeship 05-400
Poland
Hospital Garcia de Orta ( Site 3501)
Almada, Setúbal District 2805-267
Portugal
Hospital Pulido Valente ( Site 3503)
Lisbon, 1769-001
Portugal
University Clinical Hospital Center of Serbia ( Site 2901)
Belgrade, Beograd 11000
Serbia
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Novi Sad, Beograd 21000
Serbia
Institute for Cardiovascular Diseases Dedinje ( Site 2903)
Belgrade, 11000
Serbia
Gachon University Gil Medical Center ( Site 3103)
Incheon, 21565
South Korea
Severance Hospital, Yonsei University Health System ( Site 3101)
Seoul, 03722
South Korea
Samsung Medical Center ( Site 3106)
Seoul, 06351
South Korea
Hospital Universitario de Son Espases ( Site 1611)
Palma de Mallorca, Balearic Islands 07120
Spain
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander, Cantabria 39008
Spain
Hospital Universitari Vall D Hebron ( Site 1605)
Barcelona, Catalonia 08035
Spain
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
Majadahonda, Madrid 28222
Spain
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid, Madrid, Comunidad de 28041
Spain
Hospital Clinic de Barcelona ( Site 1602)
Barcelona, 08036
Spain
Hospital Universitario La Paz ( Site 1610)
Madrid, 28046
Spain
Hospital General Universitario Ramon y Cajal ( Site 1609)
Madrid, 28048
Spain
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
Toledo, 45007
Spain
Sahlgrenska Universitetssjukhuset ( Site 3201)
Gothenburg, Västra Götaland County 41346
Sweden
UniversitätsSpital Zürich ( Site 3301)
Zurich, 8091
Switzerland
Kaohsiung Veteran General Hospital ( Site 3702)
Kaohsiung City, 813
Taiwan
National Cheng Kung University Hospital ( Site 3703)
Tainan, 704302
Taiwan
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambridge, Cambridgeshire CB2 0AY
United Kingdom
Golden Jubilee National Hospital ( Site 1204)
Glasgow, Glasgow City G81 4DY
United Kingdom
Royal Free Hospital ( Site 1202)
London, London, City of NW3 2QG
United Kingdom
Royal Brompton Hospital ( Site 1206)
London, London, City of SW3 6NP
United Kingdom
Hammersmith Hospital ( Site 1203)
London, London, City of W12 0HS
United Kingdom
Freeman Hospital ( Site 1205)
Newcastle upon Tyne, NE7 7DN
United Kingdom
Royal Hallamshire Hospital ( Site 1207)
Sheffield, S10 2JF
United Kingdom