RecruitingPhase 3NCT07218029

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

815 participants

Start Date

May 12, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study for people who previously participated in a clinical trial of sotatercept (also called Winrevair) for pulmonary arterial hypertension (PAH) — a condition where blood pressure in the arteries of the lungs becomes dangerously high, causing breathing difficulties and heart strain. This study continues to provide sotatercept to eligible participants after their original trial ends. **You may be eligible if...** - You previously completed participation in a sotatercept clinical trial for pulmonary arterial hypertension - You did not leave your previous trial early - You did not miss more than 4 consecutive doses of sotatercept between the end of the parent study and the start of this one - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You did not participate in a prior sotatercept PAH trial - You had a serious side effect from sotatercept during your previous trial - You are currently enrolled in another drug study (other than a sotatercept study) - You are incapacitated or unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSotatercept

Sotatercept SC injection every 3 weeks


Locations(93)

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

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

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

Instituto Cardiovascular de Rosario ( Site 1906)

Rosario, Santa Fe Province, Argentina

Sanatorio Parque ( Site 1905)

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

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

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

Universitätsklinikum Halle ( Site 1502)

Halle, Saxony-Anhalt, Germany

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)

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

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

Hospital Garcia de Orta ( Site 3501)

Almada, Setúbal District, Portugal

Hospital Pulido Valente ( Site 3503)

Lisbon, Portugal

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

View Full Details on ClinicalTrials.gov

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NCT07218029


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