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)
Status: Recruiting
Location: See all (117) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Arizona
Pulmonary Associates, PA ( Site 1008)
ACTIVE_NOT_RECRUITING
Phoenix
Arizona Pulmonary Specialists ( Site 1010)
RECRUITING
Scottsdale
California
University of California San Diego Health ( Site 1002)
ACTIVE_NOT_RECRUITING
La Jolla
UC Irvine Health Medical Center ( Site 1086)
RECRUITING
Orange
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
ACTIVE_NOT_RECRUITING
San Francisco
Jeffrey S. Sager, MD Medical Corporation ( Site 1060)
RECRUITING
Santa Barbara
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 1028)
ACTIVE_NOT_RECRUITING
Torrance
Colorado
University of Colorado Hospital ( Site 1013)
ACTIVE_NOT_RECRUITING
Aurora
Florida
Mayo Clinic Jacksonville ( Site 1045)
ACTIVE_NOT_RECRUITING
Jacksonville
AdventHealth Orlando ( Site 1058)
RECRUITING
Orlando
Tampa General Hospital ( Site 1043)
RECRUITING
Tampa
Kansas
University of Kansas Medical Center ( Site 1020)
RECRUITING
Kansas City
Kentucky
Norton Pulmonary Specialists ( Site 1066)
RECRUITING
Louisville
Massachusetts
Tufts Medical Center ( Site 1012)
RECRUITING
Boston
Maryland
Johns Hopkins University ( Site 1036)
RECRUITING
Baltimore
North Carolina
Duke University Medical Center ( Site 1026)
RECRUITING
Durham
Nebraska
University Of Nebraska Medical Center ( Site 1053)
ACTIVE_NOT_RECRUITING
Omaha
New York
Weill Cornell Medical Center ( Site 1046)
ACTIVE_NOT_RECRUITING
New York
Ohio
The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital ( Site 1001)
RECRUITING
Cincinnati
University of Cincinnati Medical Center ( Site 1035)
RECRUITING
Cincinnati
Ohio State University Wexner Medical Center ( Site 1032)
ACTIVE_NOT_RECRUITING
Columbus
Oregon
Oregon Health & Science University ( Site 1054)
ACTIVE_NOT_RECRUITING
Portland
Pennsylvania
University of Pittsburgh Medical Center - Presbyterian Hosp. ( Site 1059)
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital ( Site 1033)
RECRUITING
Providence
South Carolina
Medical University of South Carolina ( Site 1003)
RECRUITING
Charleston
Texas
University of Texas Southwestern Medical Center ( Site 1038)
RECRUITING
Dallas
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
RECRUITING
Houston
Houston Methodist Hospital ( Site 1009)
RECRUITING
Houston
Other Locations
Argentina
Sanatorio Allende ( Site 1908)
ACTIVE_NOT_RECRUITING
Córdoba
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
ACTIVE_NOT_RECRUITING
Quilmes
Instituto Médico Río Cuarto ( Site 1907)
ACTIVE_NOT_RECRUITING
Río Cuarto
Hospital Provincial del Centenario ( Site 1912)
ACTIVE_NOT_RECRUITING
Rosario
Instituto Cardiovascular de Rosario ( Site 1906)
ACTIVE_NOT_RECRUITING
Rosario
Sanatorio Parque ( Site 1905)
ACTIVE_NOT_RECRUITING
Rosario
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
ACTIVE_NOT_RECRUITING
Santa Fe
Australia
Royal Prince Alfred Hospital ( Site 1106)
RECRUITING
Camperdown
The Prince Charles Hospital ( Site 1104)
RECRUITING
Chermside
Royal Hobart Hospital ( Site 1107)
RECRUITING
Hobart
Fiona Stanley Hospital ( Site 1103)
ACTIVE_NOT_RECRUITING
Murdoch
John Hunter Hospital ( Site 1101)
ACTIVE_NOT_RECRUITING
New Lambton Heights
Belgium
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
ACTIVE_NOT_RECRUITING
Brussels
UZ Leuven ( Site 1401)
ACTIVE_NOT_RECRUITING
Leuven
Brazil
Hospital Dia do Pulmao ( Site 1802)
RECRUITING
Blumenau
Canada
Peter Lougheed Centre ( Site 2102)
RECRUITING
Calgary
University of Alberta Hospital ( Site 2101)
RECRUITING
Edmonton
Colombia
Fundación Neumológica Colombiana ( Site 3403)
RECRUITING
Bogotá
Clínica Imbanaco S.A.S ( Site 3404)
ACTIVE_NOT_RECRUITING
Cali
Croatia
Klinicki Bolnicki Centar Split ( Site 3901)
ACTIVE_NOT_RECRUITING
Split
Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
ACTIVE_NOT_RECRUITING
Aarhus
Rigshospitalet ( Site 3802)
ACTIVE_NOT_RECRUITING
København Ø
France
CHU Angers ( Site 1313)
RECRUITING
Angers
Hopital Cavale Blanche ( Site 1314)
RECRUITING
Brest
CHU de Grenoble Hopital Nord ( Site 1303)
ACTIVE_NOT_RECRUITING
La Tronche
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
RECRUITING
Le Kremlin-bicêtre
CENTRE HOSPITALIER UNIVERSITAIRE DE LILLE ( Site 1306)
RECRUITING
Lille
Hôpital Louis Pradel ( Site 1317)
RECRUITING
Lyon
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
RECRUITING
Nice
CHU Bordeaux Haut-Leveque ( Site 1312)
RECRUITING
Pessac
CHU de la Miletrie Poitiers ( Site 1316)
RECRUITING
Poitiers
Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique ( Site 1302)
RECRUITING
Saint-étienne-de-montluc
Hopital Nord Laennec ( Site 1309)
RECRUITING
Saint-herblain
Nouvel Hôpital Civil (NHC) ( Site 1307)
ACTIVE_NOT_RECRUITING
Strasbourg
Hopital Larrey ( Site 1315)
ACTIVE_NOT_RECRUITING
Toulouse
Germany
DRK Kliniken Berlin Westend ( Site 1507)
ACTIVE_NOT_RECRUITING
Berlin
Universitaetsklinikum Koeln ( Site 1511)
RECRUITING
Cologne
Universitaetsklinikum Carl Gustav Carus ( Site 1501)
RECRUITING
Dresden
UKGM Gießen/Marburg ( Site 1512)
RECRUITING
Giessen
Universitätsklinikum Halle ( Site 1502)
RECRUITING
Halle
Medizinische Hochschule Hannover ( Site 1505)
RECRUITING
Hanover
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
RECRUITING
Heidelberg
Universitätsklinikum Leipzig ( Site 1508)
RECRUITING
Leipzig
Krankenhaus Neuwittelsbach ( Site 1510)
ACTIVE_NOT_RECRUITING
München
Universitaetsklinik Regensburg ( Site 1503)
RECRUITING
Regensburg
Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
ACTIVE_NOT_RECRUITING
Athens
Onassis Cardiac Surgery Center ( Site 3602)
RECRUITING
Athens
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
ACTIVE_NOT_RECRUITING
Thessaloniki
Israel
Carmel Hospital ( Site 1705)
RECRUITING
Haifa
Haddasah Medical Center ( Site 1711)
ACTIVE_NOT_RECRUITING
Jerusalem
Rabin Medical Center ( Site 1703)
ACTIVE_NOT_RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1701)
ACTIVE_NOT_RECRUITING
Ramat Gan
Italy
Ospedale San Giuseppe ( Site 2403)
ACTIVE_NOT_RECRUITING
Milan
Fondazione IRCCS San Gerardo dei Tintori ( Site 2406)
ACTIVE_NOT_RECRUITING
Monza
A.O.R.N. Ospedale dei Colli - Monaldi V. ( Site 2407)
ACTIVE_NOT_RECRUITING
Naples
AOU Policlinico Umberto I ( Site 2402)
ACTIVE_NOT_RECRUITING
Rome
Netherlands
Amsterdam UMC, locatie VUmc ( Site 2601)
ACTIVE_NOT_RECRUITING
Amsterdam
Radboud University Nijmegen Medical Centre ( Site 2605)
ACTIVE_NOT_RECRUITING
Nijmegen
New Zealand
Waikato Hospital ( Site 2702)
ACTIVE_NOT_RECRUITING
Hamilton
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
RECRUITING
Krakow
Europejskie Centrum Zdrowia Otwock ( Site 2802)
RECRUITING
Otwock
Portugal
Hospital Garcia de Orta ( Site 3501)
RECRUITING
Almada
Hospital Pulido Valente ( Site 3503)
RECRUITING
Lisbon
Republic of Korea
Gachon University Gil Medical Center ( Site 3103)
ACTIVE_NOT_RECRUITING
Incheon
Samsung Medical Center ( Site 3106)
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 3101)
ACTIVE_NOT_RECRUITING
Seoul
Serbia
Institute for Cardiovascular Diseases Dedinje ( Site 2903)
ACTIVE_NOT_RECRUITING
Belgrade
University Clinical Hospital Center of Serbia ( Site 2901)
ACTIVE_NOT_RECRUITING
Belgrade
Institute for pulmonary diseases of Vojvodina ( Site 2906)
ACTIVE_NOT_RECRUITING
Novi Sad
Spain
Hospital Clinic de Barcelona ( Site 1602)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari Vall D Hebron ( Site 1605)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital General Universitario Ramon y Cajal ( Site 1609)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 1603)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz ( Site 1610)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
ACTIVE_NOT_RECRUITING
Majadahonda
Hospital Universitario de Son Espases ( Site 1611)
ACTIVE_NOT_RECRUITING
Palma De Mallorca
Hospital Universitario Marques de Valdecilla ( Site 1601)
ACTIVE_NOT_RECRUITING
Santander
HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1607)
ACTIVE_NOT_RECRUITING
Toledo
Sweden
Sahlgrenska Universitetssjukhuset ( Site 3201)
ACTIVE_NOT_RECRUITING
Gothenburg
Switzerland
UniversitätsSpital Zürich ( Site 3301)
ACTIVE_NOT_RECRUITING
Zurich
Taiwan
Kaohsiung Veteran General Hospital ( Site 3702)
ACTIVE_NOT_RECRUITING
Kaohsiung City
National Cheng Kung University Hospital ( Site 3703)
ACTIVE_NOT_RECRUITING
Tainan
United Kingdom
Papworth Hospital NHS Foundation Trust ( Site 1208)
ACTIVE_NOT_RECRUITING
Cambridge
Golden Jubilee National Hospital ( Site 1204)
ACTIVE_NOT_RECRUITING
Glasgow
Hammersmith Hospital ( Site 1203)
ACTIVE_NOT_RECRUITING
London
Royal Brompton Hospital ( Site 1206)
ACTIVE_NOT_RECRUITING
London
Royal Free Hospital ( Site 1202)
ACTIVE_NOT_RECRUITING
London
Freeman Hospital ( Site 1205)
ACTIVE_NOT_RECRUITING
Newcastle Upon Tyne
Royal Hallamshire Hospital ( Site 1207)
ACTIVE_NOT_RECRUITING
Sheffield
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2021-05-12
Estimated Completion Date: 2028-12-07
Participants
Target number of participants: 815
Treatments
Experimental: Sotatercept
Participants enrolling from blinded PAH sotatercept studies will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection and can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. Participants enrolling from unblinded PAH sotatercept studies will continue sotatercept at their current dose and, if at a dose \<0.7 mg/kg, can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC