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

NCT07218029 · Merck Sharp & Dohme LLC
In plain English

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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)
About this study
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
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
Study design
Enrollment target: 815 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-05-12
Estimated completion: 2028-12-07
Last updated: 2026-04-06
Interventions
Biological: Sotatercept
Primary outcomes
  • Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 90 months)
  • Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 86 months)
  • Number of Participants with Detectable Anti-Drug Antibodies (ADAs) (Up to approximately 88 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (85)
Pulmonary Associates, PA ( Site 1008)Active Not Recruiting
Phoenix, Arizona, United States
University of California San Diego Health ( Site 1002)Recruiting
La Jolla, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)Recruiting
San Francisco, California, United States
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)Recruiting
Santa Barbara, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)Recruiting
Torrance, California, United States
University of Colorado Hospital ( Site 1013)Active Not Recruiting
Aurora, Colorado, United States
Mayo Clinic Jacksonville ( Site 1045)Recruiting
Jacksonville, Florida, United States
AdventHealth Orlando ( Site 1058)Recruiting
Orlando, Florida, United States
University of Kansas Medical Center ( Site 1020)Recruiting
Kansas City, Kansas, United States
Norton Pulmonary Specialists ( Site 1066)Recruiting
Louisville, Kentucky, United States
Tufts Medical Center ( Site 1012)Recruiting
Boston, Massachusetts, United States
University Of Nebraska Medical Center ( Site 1053)Active Not Recruiting
Omaha, Nebraska, United States
Weill Cornell Medical Center ( Site 1046)Active Not Recruiting
New York, New York, United States
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)Recruiting
Cincinnati, Ohio, United States
University of Cincinnati Medical Center ( Site 1035)Recruiting
Cincinnati, Ohio, United States
Ohio State University Wexner Medical Center ( Site 1032)Active Not Recruiting
Columbus, Ohio, United States
Oregon Health & Science University ( Site 1054)Recruiting
Portland, Oregon, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)Recruiting
Houston, Texas, United States
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)Recruiting
Quilmes, Buenos Aires, Argentina
Instituto Médico Río Cuarto ( Site 1907)Recruiting
Río Cuarto, Córdoba Province, Argentina
Instituto Cardiovascular de Rosario ( Site 1906)Recruiting
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 1905)Recruiting
Rosario, Santa Fe Province, Argentina
Sanatorio Allende ( Site 1908)Recruiting
Córdoba, Argentina
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)Recruiting
Santa Fe, Argentina
Royal Prince Alfred Hospital ( Site 1106)Recruiting
Camperdown, New South Wales, Australia
John Hunter Hospital ( Site 1101)Active Not Recruiting
New Lambton Heights, New South Wales, Australia
Royal Hobart Hospital ( Site 1107)Recruiting
Hobart, Tasmania, Australia
Fiona Stanley Hospital ( Site 1103)Recruiting
Murdoch, Western Australia, Australia
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)Recruiting
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven ( Site 1401)Recruiting
Leuven, Vlaams-Brabant, Belgium
Clínica Imbanaco S.A.S ( Site 3404)Recruiting
Cali, Valle del Cauca Department, Colombia
Klinicki Bolnicki Centar Split ( Site 3901)Recruiting
Split, Split-Dalmatia County, Croatia
Institut Klinicke a Experimentalni Mediciny ( Site 2202)Recruiting
Prague, Praha 4, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 2201)Recruiting
Prague, Czechia
Rigshospitalet ( Site 3802)Active Not Recruiting
København Ø, Capital Region, Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)Active Not Recruiting
Aarhus, Central Jutland, Denmark
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)Recruiting
Nice, Alpes-Maritimes, France
CHU Bordeaux Haut-Leveque ( Site 1312)Recruiting
Pessac, Aquitaine, France
Nouvel Hôpital Civil (NHC) ( Site 1307)Recruiting
Strasbourg, Bas-Rhin, France
Hopital Cavale Blanche ( Site 1314)Recruiting
Brest, Finistere, France
Hopital Larrey ( Site 1315)Recruiting
Toulouse, Haute-Garonne, France
Institut Coeur Poumon - CHRU de Lille ( Site 1306)Recruiting
Lille, Hauts-de-France, France
CHU de Grenoble Hopital Nord ( Site 1303)Recruiting
La Tronche, Isere, France
Hopital Nord Laennec ( Site 1309)Recruiting
Saint-Herblain, Loire-Atlantique, France
CHU Angers ( Site 1313)Recruiting
Angers, Maine-et-Loire, France
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)Recruiting
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Hôpital Louis Pradel ( Site 1317)Recruiting
Lyon, Rhone, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)Recruiting
Le Kremlin-Bicêtre, Val-de-Marne, France
CHU de la Miletrie Poitiers ( Site 1316)Recruiting
Poitiers, Vienne, France
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)Recruiting
Athens, Attica, Greece
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)Recruiting
Thessaloniki, Greece
Carmel Hospital ( Site 1705)Recruiting
Haifa, Israel
Haddasah Medical Center ( Site 1711)Recruiting
Jerusalem, Israel
Rabin Medical Center ( Site 1703)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 1701)Recruiting
Ramat Gan, Israel
Ospedale San Giuseppe ( Site 2403)Recruiting
Milan, Milano, Italy
AOU Policlinico Umberto I ( Site 2402)Recruiting
Rome, Roma, Italy
Radboud University Nijmegen Medical Centre ( Site 2605)Recruiting
Nijmegen, Gelderland, Netherlands
Amsterdam UMC, locatie VUmc ( Site 2601)Active Not Recruiting
Amsterdam, North Holland, Netherlands
Waikato Hospital ( Site 2702)Active Not Recruiting
Hamilton, Waikato Region, New Zealand
Hospital Garcia de Orta ( Site 3501)Recruiting
Almada, Setúbal District, Portugal
Institute for pulmonary diseases of Vojvodina ( Site 2906)Recruiting
Novi Sad, Beograd, Serbia
Gachon University Gil Medical Center ( Site 3103)Active Not Recruiting
Incheon, South Korea
Severance Hospital, Yonsei University Health System ( Site 3101)Active Not Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 3106)Active Not Recruiting
Seoul, South Korea
Hospital Universitario de Son Espases ( Site 1611)Active Not Recruiting
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Marques de Valdecilla ( Site 1601)Active Not Recruiting
Santander, Cantabria, Spain
Hospital Universitari Vall D Hebron ( Site 1605)Recruiting
Barcelona, Catalonia, Spain
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)Recruiting
Majadahonda, Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 1603)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Clinic de Barcelona ( Site 1602)Active Not Recruiting
Barcelona, Spain
Hospital Universitario La Paz ( Site 1610)Active Not Recruiting
Madrid, Spain
Hospital General Universitario Ramon y Cajal ( Site 1609)Recruiting
Madrid, Spain
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)Recruiting
Toledo, Spain
Sahlgrenska Universitetssjukhuset ( Site 3201)Active Not Recruiting
Gothenburg, Västra Götaland County, Sweden
UniversitätsSpital Zürich ( Site 3301)Active Not Recruiting
Zurich, Switzerland
Kaohsiung Veteran General Hospital ( Site 3702)Active Not Recruiting
Kaohsiung City, Taiwan
National Cheng Kung University Hospital ( Site 3703)Active Not Recruiting
Tainan, Taiwan
Papworth Hospital NHS Foundation Trust ( Site 1208)Active Not Recruiting
Cambridge, Cambridgeshire, United Kingdom
Golden Jubilee National Hospital ( Site 1204)Recruiting
Glasgow, Glasgow City, United Kingdom
Royal Free Hospital ( Site 1202)Recruiting
London, London, City of, United Kingdom
Royal Brompton Hospital ( Site 1206)Recruiting
London, London, City of, United Kingdom
Hammersmith Hospital ( Site 1203)Active Not Recruiting
London, London, City of, United Kingdom
Freeman Hospital ( Site 1205)Active Not Recruiting
Newcastle upon Tyne, United Kingdom
Royal Hallamshire Hospital ( Site 1207)Active Not Recruiting
Sheffield, United Kingdom
A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) · TrialPath