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Recruiting Phase 3 NCT07218029

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

Phase 3 – large-scale trial before approval
Conditions: Pulmonary Arterial Hypertension

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Sotatercept
BIOLOGICAL
Locations 93
Argentina (7)
Sanatorio Allende ( Site 1908)
Córdoba
Study Coordinator
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes , Buenos Aires
Study Coordinator
Instituto Médico Río Cuarto ( Site 1907)
Río Cuarto , Córdoba Province
Study Coordinator
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario , Santa Fe Province
ACTIVE_NOT_RECRUITING
Sanatorio Parque ( Site 1905)
Rosario , Santa Fe Province
ACTIVE_NOT_RECRUITING
Hospital Provincial del Centenario ( Site 1912)
Rosario , Santa Fe Province
Study Coordinator
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
Santa Fe
Study Coordinator
Australia (4)
Royal Prince Alfred Hospital ( Site 1106)
Camperdown , New South Wales
Study Coordinator
Royal Hobart Hospital ( Site 1107)
Hobart , Tasmania
Study Coordinator
Fiona Stanley Hospital ( Site 1103)
Murdoch , Western Australia
Study Coordinator
John Hunter Hospital ( Site 1101)
New Lambton Heights , New South Wales
ACTIVE_NOT_RECRUITING
Belgium (2)
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
Brussels , Bruxelles-Capitale, Region de
Study Coordinator
UZ Leuven ( Site 1401)
Leuven , Vlaams-Brabant
Study Coordinator
Colombia (2)
Fundación Neumológica Colombiana ( Site 3403)
Bogotá , Bogota D.C.
Study Coordinator
Clínica Imbanaco S.A.S ( Site 3404)
Cali , Valle del Cauca Department
Study Coordinator
Croatia (1)
Klinicki Bolnicki Centar Split ( Site 3901)
Split , Split-Dalmatia County
Study Coordinator
Czech Republic (2)
Institut Klinicke a Experimentalni Mediciny ( Site 2202)
Prague , Praha 4
Study Coordinator
Vseobecna fakultni nemocnice v Praze ( Site 2201)
Prague
Study Coordinator
Denmark (2)
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus , Central Jutland
ACTIVE_NOT_RECRUITING
Rigshospitalet ( Site 3802)
København Ø , Capital Region
ACTIVE_NOT_RECRUITING
France (13)
CHU Angers ( Site 1313)
Angers , Maine-et-Loire
Study Coordinator
Hopital Cavale Blanche ( Site 1314)
Brest , Finistere
Study Coordinator
CHU de Grenoble Hopital Nord ( Site 1303)
La Tronche , Isere
ACTIVE_NOT_RECRUITING
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
Le Kremlin-Bicêtre , Val-de-Marne
Study Coordinator
CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE ( Site 1306)
Lille , Nord
Study Coordinator
Hôpital Louis Pradel ( Site 1317)
Lyon , Rhone
Study Coordinator
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
Nice , Alpes-Maritimes
Study Coordinator
CHU Bordeaux Haut-Leveque ( Site 1312)
Pessac , Aquitaine
Study Coordinator
CHU de la Miletrie Poitiers ( Site 1316)
Poitiers , Vienne
Study Coordinator
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
Saint-Étienne-de-Montluc , Pays de la Loire Region
Study Coordinator
Hopital Nord Laennec ( Site 1309)
Saint-Herblain , Loire-Atlantique
Study Coordinator
Nouvel Hôpital Civil (NHC) ( Site 1307)
Strasbourg , Bas-Rhin
Study Coordinator
Hopital Larrey ( Site 1315)
Toulouse , Haute-Garonne
Study Coordinator
Germany (1)
Universitätsklinikum Halle ( Site 1502)
Halle , Saxony-Anhalt
Study Coordinator
Greece (2)
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
Athens , Attica
Study Coordinator
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
Thessaloniki
Study Coordinator
Israel (4)
Carmel Hospital ( Site 1705)
Haifa
Study Coordinator
Haddasah Medical Center ( Site 1711)
Jerusalem
Study Coordinator
Rabin Medical Center ( Site 1703)
Petah Tikva
Study Coordinator
Sheba Medical Center ( Site 1701)
Ramat Gan
Study Coordinator
Italy (3)
Ospedale San Giuseppe ( Site 2403)
Milan , Milano
Study Coordinator
Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)
Monza , Lombardy
Study Coordinator
AOU Policlinico Umberto I ( Site 2402)
Rome , Roma
Study Coordinator
Netherlands (2)
Amsterdam UMC, locatie VUmc ( Site 2601)
Amsterdam , North Holland
ACTIVE_NOT_RECRUITING
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen , Gelderland
Study Coordinator
New Zealand (1)
Waikato Hospital ( Site 2702)
Hamilton , Waikato Region
ACTIVE_NOT_RECRUITING
Portugal (2)
Hospital Garcia de Orta ( Site 3501)
Almada , Setúbal District
Study Coordinator
Hospital Pulido Valente ( Site 3503)
Lisbon
Study Coordinator
Serbia (2)
Institute for Cardiovascular Diseases Dedinje ( Site 2903)
Belgrade
Study Coordinator
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Novi Sad , Beograd
Study Coordinator
South Korea (3)
Gachon University Gil Medical Center ( Site 3103)
Incheon
ACTIVE_NOT_RECRUITING
Severance Hospital, Yonsei University Health System ( Site 3101)
Seoul
ACTIVE_NOT_RECRUITING
Samsung Medical Center ( Site 3106)
Seoul
ACTIVE_NOT_RECRUITING
Spain (9)
Hospital Universitari Vall D Hebron ( Site 1605)
Barcelona , Catalonia
Study Coordinator
Hospital Clinic de Barcelona ( Site 1602)
Barcelona
ACTIVE_NOT_RECRUITING
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid , Madrid, Comunidad de
Study Coordinator
Hospital Universitario La Paz ( Site 1610)
Madrid
ACTIVE_NOT_RECRUITING
Hospital General Universitario Ramon y Cajal ( Site 1609)
Madrid
ACTIVE_NOT_RECRUITING
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
Majadahonda , Madrid
Study Coordinator
Hospital Universitario de Son Espases ( Site 1611)
Palma de Mallorca , Balearic Islands
ACTIVE_NOT_RECRUITING
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander , Cantabria
ACTIVE_NOT_RECRUITING
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
Toledo
Study Coordinator
Sweden (1)
Sahlgrenska Universitetssjukhuset ( Site 3201)
Gothenburg , Västra Götaland County
ACTIVE_NOT_RECRUITING
Switzerland (1)
UniversitätsSpital Zürich ( Site 3301)
Zurich
ACTIVE_NOT_RECRUITING
Taiwan (2)
Kaohsiung Veteran General Hospital ( Site 3702)
Kaohsiung City
ACTIVE_NOT_RECRUITING
National Cheng Kung University Hospital ( Site 3703)
Tainan
ACTIVE_NOT_RECRUITING
United Kingdom (7)
Papworth Hospital NHS Foundation Trust ( Site 1208)
Cambridge , Cambridgeshire
ACTIVE_NOT_RECRUITING
Golden Jubilee National Hospital ( Site 1204)
Glasgow , Glasgow City
Study Coordinator
Royal Free Hospital ( Site 1202)
London , London, City of
Study Coordinator
Royal Brompton Hospital ( Site 1206)
London , London, City of
ACTIVE_NOT_RECRUITING
Hammersmith Hospital ( Site 1203)
London , London, City of
ACTIVE_NOT_RECRUITING
Freeman Hospital ( Site 1205)
Newcastle upon Tyne
ACTIVE_NOT_RECRUITING
Royal Hallamshire Hospital ( Site 1207)
Sheffield
ACTIVE_NOT_RECRUITING
United States (20)
University of Colorado Hospital ( Site 1013)
Aurora , Colorado
ACTIVE_NOT_RECRUITING
Johns Hopkins University ( Site 1036)
Baltimore , Maryland
Study Coordinator
Tufts Medical Center ( Site 1012)
Boston , Massachusetts
Study Coordinator
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
Cincinnati , Ohio
Study Coordinator
University of Cincinnati Medical Center ( Site 1035)
Cincinnati , Ohio
Study Coordinator
Ohio State University Wexner Medical Center ( Site 1032)
Columbus , Ohio
ACTIVE_NOT_RECRUITING
Duke University Medical Center ( Site 1026)
Durham , North Carolina
Study Coordinator
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
Houston , Texas
Study Coordinator
Mayo Clinic Jacksonville ( Site 1045)
Jacksonville , Florida
Study Coordinator
University of Kansas Medical Center ( Site 1020)
Kansas City , Kansas
Study Coordinator
University of California San Diego Health ( Site 1002)
La Jolla , California
ACTIVE_NOT_RECRUITING
Norton Pulmonary Specialists ( Site 1066)
Louisville , Kentucky
Study Coordinator
Weill Cornell Medical Center ( Site 1046)
New York , New York
ACTIVE_NOT_RECRUITING
University Of Nebraska Medical Center ( Site 1053)
Omaha , Nebraska
ACTIVE_NOT_RECRUITING
AdventHealth Orlando ( Site 1058)
Orlando , Florida
Study Coordinator
Pulmonary Associates, PA ( Site 1008)
Phoenix , Arizona
ACTIVE_NOT_RECRUITING
Oregon Health & Science University ( Site 1054)
Portland , Oregon
Study Coordinator
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
San Francisco , California
ACTIVE_NOT_RECRUITING
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
Santa Barbara , California
Study Coordinator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
Torrance , California
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.05.2021
Completion date
07.12.2028
Registry ID
NCT07218029
Source
clinicaltrials.gov
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