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NCT07218029PHASE3Recruiting

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

Merck Sharp & Dohme LLC

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

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

Interventions

BIOLOGICAL

Sotatercept

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Conditions

Pulmonary Arterial Hypertension

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