NCT07218029Active, not recruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 815 (estimated)
- First submitted
- 7 Oct 2025
- Start date
- 12 May 2021
- Primary completion date
- 7 Dec 2028
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Pulmonary arterial hypertension
- NCT number
- NCT07218029
- EU CT number
- 2025-521970-33-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 815
- From 12 May 2021 to the primary completion date, 7 Dec 2028
- 137 sites in 27 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is currently enrolled in another investigational product study other than a sotatercept study
Other
- 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 incapacitated
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (137)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanatorio Allende (Site 1908) | Córdoba | Argentina | Unknown status |
| Instituto de Investigaciones Clinicas Quilmes (Site 1903) | Quilmes | Argentina | Unknown status |
| Instituto Médico Río Cuarto (Site 1907) | Río Cuarto | Argentina | Unknown status |
| Sanatorio Parque (Site 1905) | Rosario | Argentina | Unknown status |
| Instituto Cardiovascular de Rosario (Site 1906) | Rosario | Argentina | Unknown status |
| Hospital Provincial del Centenario (Site 1912) | Rosario | Argentina | Unknown status |
| Hospital Provincial Dr. Jose M. Cullen (Site 1902) | Santa Fe | Argentina | Unknown status |
| Royal Adelaide Hospital (Site 1109) | Adelaide | Australia | Unknown status |
| Royal Prince Alfred Hospital (Site 1106) | Camperdown | Australia | Unknown status |
| The Prince Charles Hospital (Site 1104) | Chermside | Australia | Unknown status |
| Saint Vincents Hospital Sydney (Site 1102) | Darlinghurst | Australia | Unknown status |
| Royal Hobart Hospital (Site 1107) | Hobart | Australia | Unknown status |
| Fiona Stanley Hospital (Site 1103) | Murdoch | Australia | Unknown status |
| John Hunter Hospital (Site 1101) | New Lambton Heights | Australia | Unknown status |
| Université Libre de Bruxelles - Hôpital Erasme (Site 1402) | Brussels | Belgium | Unknown status |
| UZ Leuven (Site 1401) | Leuven | Belgium | Unknown status |
| Hospital Madre Teresa (Site 1804) | Belo Horizonte | Brazil | Unknown status |
| Hospital Dia do Pulmao (Site 1802) | Blumenau | Brazil | Unknown status |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre (Site 1805) | Porto Alegre | Brazil | Unknown status |
| Hospital Sao Paulo (Site 1806) | São Paulo | Brazil | Unknown status |
| Instituto do Coracao - HCFMUSP (Site 1803) | São Paulo | Brazil | Unknown status |
| Peter Lougheed Centre (Site 2102) | Calgary | Canada | Unknown status |
| University of Alberta Hospital (Site 2101) | Edmonton | Canada | Unknown status |
| St. Joseph's Healthcare Hamilton (Site 2105) | Hamilton | Canada | Unknown status |
| UniversitätsSpital Zürich (Site 3301) | Zurich | Switzerland | Unknown status |
| Fundación Neumológica Colombiana (Site 3403) | Bogotá | Colombia | Unknown status |
| Clínica Imbanaco S.A.S (Site 3404) | Cali | Colombia | Unknown status |
| Institut Klinicke a Experimentalni Mediciny (Site 2202) | Prague | Czechia | Unknown status |
| Vseobecna fakultni nemocnice v Praze (Site 2201) | Prague | Czechia | Unknown status |
| DRK Kliniken Berlin Westend (Site 1507) | Berlin | Germany | Unknown status |
| Universitaetsklinikum Koeln (Site 1511) | Cologne | Germany | Unknown status |
| Universitaetsklinikum Carl Gustav Carus (Site 1501) | Dresden | Germany | Unknown status |
| UKGM Gießen/Marburg (Site 1512) | Giessen | Germany | Unknown status |
| Universitätsklinikum Halle (Site 1502) | Halle | Germany | Unknown status |
| Medizinische Hochschule Hannover (Site 1505) | Hanover | Germany | Unknown status |
| Thoraxklinik-Heidelberg gGmbH (Site 1509) | Heidelberg | Germany | Unknown status |
| Universitätsklinikum Leipzig (Site 1508) | Leipzig | Germany | Unknown status |
| Krankenhaus Neuwittelsbach (Site 1510) | Munich | Germany | Unknown status |
| Universitaetsklinik Regensburg (Site 1503) | Regensburg | Germany | Unknown status |
| Aarhus Universitetshospital, Skejby (Site 3801) | Aarhus | Denmark | Unknown status |
| Rigshospitalet (Site 3802) | København Ø | Denmark | Unknown status |
| Hospital Universitari Vall D Hebron (Site 1605) | Barcelona | Spain | Unknown status |
| Hospital Clinic de Barcelona (Site 1602) | Barcelona | Spain | Unknown status |
| Hospital Universitario 12 de Octubre (Site 1603) | Madrid | Spain | Unknown status |
| Hospital General Universitario Ramon y Cajal (Site 1609) | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz (Site 1610) | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro (Majadahonda) (Site 1604) | Majadahonda | Spain | Unknown status |
| Hospital Universitario de Son Espases (Site 1611) | Palma de Mallorca | Spain | Unknown status |
| Hospital Universitario Marques de Valdecilla (Site 1601) | Santander | Spain | Unknown status |
| HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO (Site 1607) | Toledo | Spain | Unknown status |
| CHU Angers (Site 1313) | Angers | France | Unknown status |
| Hopital Cavale Blanche (Site 1314) | Brest | France | Unknown status |
| CHU de Grenoble Hopital Nord (Site 1303) | La Tronche | France | Unknown status |
| Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie (Site 1304) | Le Kremlin-Bicêtre | France | Unknown status |
| Institut Coeur Poumon - CHRU de Lille (Site 1306) | Lille | France | Unknown status |
| Hôpital Louis Pradel (Site 1317) | Lyon | France | Unknown status |
| Centre Hospitalier Universitaire de Nice - Hopital Pasteur (Site 1311) | Nice | France | Unknown status |
| CHU Bordeaux Haut-Leveque (Site 1312) | Pessac | France | Unknown status |
| CHU de la Miletrie Poitiers (Site 1316) | Poitiers | France | Unknown status |
| Centre Hospitalier Universitaire de Saint Étienne- Hôpital Nord-Medecine Vasculaire et Therapeutique (Site 1302) | Saint-Étienne-de-Montluc | France | Unknown status |
| Hopital Nord Laennec (Site 1309) | Saint-Herblain | France | Unknown status |
| Nouvel Hôpital Civil (NHC) (Site 1307) | Strasbourg | France | Unknown status |
| Hopital Larrey (Site 1315) | Toulouse | France | Unknown status |
| Papworth Hospital NHS Foundation Trust (Site 1208) | Cambridge | United Kingdom | Unknown status |
| Golden Jubilee National Hospital (Site 1204) | Glasgow | United Kingdom | Unknown status |
| Royal Brompton Hospital (Site 1206) | London | United Kingdom | Unknown status |
| Hammersmith Hospital (Site 1203) | London | United Kingdom | Unknown status |
| Royal Free Hospital (Site 1202) | London | United Kingdom | Unknown status |
| Freeman Hospital (Site 1205) | Newcastle upon Tyne | United Kingdom | Unknown status |
| Royal Hallamshire Hospital (Site 1207) | Sheffield | United Kingdom | Unknown status |
| ATTIKON GENERAL UNIVERSITY HOSPITAL (Site 3604) | Athens | Greece | Unknown status |
| Onassis Cardiac Surgery Center (Site 3602) | Athens | Greece | Unknown status |
| AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic (Site 3601) | Thessaloniki | Greece | Unknown status |
| Klinicki Bolnicki Centar Split (Site 3901) | Split | Croatia | Unknown status |
| Carmel Hospital (Site 1705) | Haifa | Israel | Unknown status |
| Haddasah Medical Center (Site 1711) | Jerusalem | Israel | Unknown status |
| Meir Medical Center. (Site 1707) | Kfar Saba | Israel | Unknown status |
| Rabin Medical Center (Site 1703) | Petah Tikva | Israel | Unknown status |
| Sheba Medical Center (Site 1701) | Ramat Gan | Israel | Unknown status |
| Ospedale San Giuseppe (Site 2403) | Milan | Italy | Unknown status |
| Fondazione IRCCS San Gerardo dei Tintori (Site 2406) | Monza | Italy | Unknown status |
| A.O.R.N. Ospedale dei Colli - Monaldi V. (Site 2407) | Naples | Italy | Unknown status |
| AOU Policlinico Umberto I (Site 2402) | Rome | Italy | Unknown status |
| Gachon University Gil Medical Center (Site 3103) | Incheon | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System (Site 3101) | Seoul | South Korea | Unknown status |
| Samsung Medical Center (Site 3106) | Seoul | South Korea | Unknown status |
| Instituto Nacional de Cardiologia Ignacio Chavez (Site 2503) | Mexico City | Mexico | Unknown status |
| Unidad de Investigacion Clinica en Medicina, S.C. (Site 2505) | Monterrey | Mexico | Unknown status |
| Amsterdam UMC, locatie VUmc (Site 2601) | Amsterdam | Netherlands | Unknown status |
| Radboud University Nijmegen Medical Centre (Site 2605) | Nijmegen | Netherlands | Unknown status |
| Waikato Hospital (Site 2702) | Hamilton | New Zealand | Unknown status |
| Krakowski Szpital Specjalistyczny im Jana Pawla II (Site 2801) | Krakow | Poland | Unknown status |
| Europejskie Centrum Zdrowia Otwock (Site 2802) | Otwock | Poland | Unknown status |
| Hospital Garcia de Orta (Site 3501) | Almada | Portugal | Unknown status |
| Hospital Pulido Valente (Site 3503) | Lisbon | Portugal | Unknown status |
| University Clinical Hospital Center of Serbia (Site 2901) | Belgrade | Serbia | Unknown status |
| Institute for Cardiovascular Diseases Dedinje (Site 2903) | Belgrade | Serbia | Unknown status |
| Institute for pulmonary diseases of Vojvodina (Site 2906) | Novi Sad | Serbia | Unknown status |
| Sahlgrenska Universitetssjukhuset (Site 3201) | Gothenburg | Sweden | Unknown status |
| Kaohsiung Veteran General Hospital (Site 3702) | Kaohsiung City | Taiwan | Unknown status |
| National Cheng Kung University Hospital (Site 3703) | Tainan | Taiwan | Unknown status |
| The Emory Clinic (Site 1030) | Atlanta | United States | Unknown status |
| University of Colorado Hospital (Site 1013) | Aurora | United States | Unknown status |
| Johns Hopkins University (Site 1036) | Baltimore | United States | Unknown status |
| Brigham and Women's Hospital (Site 1014) | Boston | United States | Unknown status |
| Tufts Medical Center (Site 1012) | Boston | United States | Unknown status |
| Medical University of South Carolina (Site 1003) | Charleston | United States | Unknown status |
| University of Cincinnati Medical Center (Site 1035) | Cincinnati | United States | Unknown status |
| The Carl and Edyth Lindner Center for Research and Education at the Christ Hospital (Site 1001) | Cincinnati | United States | Unknown status |
| Cleveland Clinic Main (Site 1065) | Cleveland | United States | Unknown status |
| Ohio State University Wexner Medical Center (Site 1032) | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center (Site 1038) | Dallas | United States | Unknown status |
| Duke University Medical Center (Site 1026) | Durham | United States | Unknown status |
| CHI St. Luke's Health Baylor College of Medicine Medical Center (Site 1044) | Houston | United States | Unknown status |
| Houston Methodist Hospital (Site 1009) | Houston | United States | Unknown status |
| Mayo Clinic Jacksonville (Site 1045) | Jacksonville | United States | Unknown status |
| University of Kansas Medical Center (Site 1020) | Kansas City | United States | Unknown status |
| University of California San Diego Health (Site 1002) | La Jolla | United States | Unknown status |
| Norton Pulmonary Specialists (Site 1066) | Louisville | United States | Unknown status |
| Froedtert Hospital & the Medical College of Wisconsin (Site 1051) | Milwaukee | United States | Unknown status |
| University of Minnesota (Site 1062) | Minneapolis | United States | Unknown status |
| Weill Cornell Medical Center (Site 1046) | New York | United States | Unknown status |
| University Of Nebraska Medical Center (Site 1053) | Omaha | United States | Unknown status |
| UC Irvine Health Medical Center (Site 1086) | Orange | United States | Unknown status |
| AdventHealth Orlando (Site 1058) | Orlando | United States | Unknown status |
| Pulmonary Associates, PA (Site 1008) | Phoenix | United States | Unknown status |
| University of Pittsburgh Medical Center - Presbyterian Hosp. (Site 1059) | Pittsburgh | United States | Unknown status |
| Oregon Health Science University (Site 1054) | Portland | United States | Unknown status |
| Rhode Island Hospital (Site 1033) | Providence | United States | Unknown status |
| UC Davis - Medial Center (Site 1064) | Sacramento | United States | Unknown status |
| UCSF Helen Diller Medical Center at Parnassus Heights (Site 1019) | San Francisco | United States | Unknown status |
| Jeffrey S. Sager, MD Medical Corporation (Site 1060) | Santa Barbara | United States | Unknown status |
| Arizona Pulmonary Specialists (Site 1010) | Scottsdale | United States | Unknown status |
| Tampa General Hospital (Site 1043) | Tampa | United States | Unknown status |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 1028) | Torrance | United States | Unknown status |
| University of Arizona (Site 1006) | Tucson | United States | Unknown status |
| George Washington University Medical Faculty Associates (Site 1025) | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.