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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 (83) 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
California
University of California San Diego Health ( Site 1002)
RECRUITING
La Jolla
UCSF Helen Diller Medical Center at Parnassus Heights ( Site 1019)
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)
RECRUITING
Torrance
Colorado
University of Colorado Hospital ( Site 1013)
ACTIVE_NOT_RECRUITING
Aurora
Florida
Mayo Clinic Jacksonville ( Site 1045)
RECRUITING
Jacksonville
AdventHealth Orlando ( Site 1058)
RECRUITING
Orlando
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
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)
RECRUITING
Portland
Texas
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
RECRUITING
Houston
Other Locations
Argentina
Sanatorio Allende ( Site 1908)
RECRUITING
Córdoba
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
RECRUITING
Quilmes
Instituto Médico Río Cuarto ( Site 1907)
RECRUITING
Río Cuarto
Instituto Cardiovascular de Rosario ( Site 1906)
RECRUITING
Rosario
Sanatorio Parque ( Site 1905)
RECRUITING
Rosario
Hospital Provincial Dr. Jose M. Cullen ( Site 1902)
RECRUITING
Santa Fe
Australia
Royal Prince Alfred Hospital ( Site 1106)
RECRUITING
Camperdown
Royal Hobart Hospital ( Site 1107)
RECRUITING
Hobart
Fiona Stanley Hospital ( Site 1103)
RECRUITING
Murdoch
John Hunter Hospital ( Site 1101)
ACTIVE_NOT_RECRUITING
New Lambton Heights
Belgium
Université Libre de Bruxelles - Hôpital Erasme ( Site 1402)
RECRUITING
Brussels
UZ Leuven ( Site 1401)
RECRUITING
Leuven
Colombia
Clínica Imbanaco S.A.S ( Site 3404)
RECRUITING
Cali
Croatia
Klinicki Bolnicki Centar Split ( Site 3901)
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)
RECRUITING
La Tronche
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre-Pneumologie ( Site 1304)
RECRUITING
Le Kremlin-bicêtre
Institut Coeur Poumon - CHRU 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)
RECRUITING
Strasbourg
Hopital Larrey ( Site 1315)
RECRUITING
Toulouse
Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3604)
RECRUITING
Athens
AHEPA University General Hospital of Thessaloniki-1st Cardiology Clinic ( Site 3601)
RECRUITING
Thessaloniki
Israel
Carmel Hospital ( Site 1705)
RECRUITING
Haifa
Haddasah Medical Center ( Site 1711)
RECRUITING
Jerusalem
Rabin Medical Center ( Site 1703)
RECRUITING
Petah Tikva
Sheba Medical Center ( Site 1701)
RECRUITING
Ramat Gan
Italy
Ospedale San Giuseppe ( Site 2403)
RECRUITING
Milan
AOU Policlinico Umberto I ( Site 2402)
RECRUITING
Rome
Netherlands
Amsterdam UMC, locatie VUmc ( Site 2601)
ACTIVE_NOT_RECRUITING
Amsterdam
Radboud University Nijmegen Medical Centre ( Site 2605)
RECRUITING
Nijmegen
New Zealand
Waikato Hospital ( Site 2702)
ACTIVE_NOT_RECRUITING
Hamilton
Portugal
Hospital Garcia de Orta ( Site 3501)
RECRUITING
Almada
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 pulmonary diseases of Vojvodina ( Site 2906)
RECRUITING
Novi Sad
Spain
Hospital Clinic de Barcelona ( Site 1602)
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitari Vall D Hebron ( Site 1605)
RECRUITING
Barcelona
Hospital General Universitario Ramon y Cajal ( Site 1609)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 1603)
RECRUITING
Madrid
Hospital Universitario La Paz ( Site 1610)
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
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)
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)
RECRUITING
Glasgow
Hammersmith Hospital ( Site 1203)
ACTIVE_NOT_RECRUITING
London
Royal Brompton Hospital ( Site 1206)
RECRUITING
London
Royal Free Hospital ( Site 1202)
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

This content was sourced from clinicaltrials.gov

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