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-7962-004)

Who is this study for? Adult patients with pulmonary hypertension
What treatments are being studied? Sotatercept
Status: Active_not_recruiting
Location: See all (187) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin. The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early

• Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements

• Must have the ability to understand and provide documented informed consent

• Females of childbearing potential must:

‣ Have a negative pregnancy test as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug

⁃ If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug

⁃ Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug

• Male participants must:

‣ Agree to use a condom, defined as a male latex condom or non latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy

⁃ Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug

• Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study, except for the MK-7962-038 study

Locations
United States
Arizona
Pulmonary Associates, PA ( Site 1008)
Phoenix
Arizona Pulmonary Specialists ( Site 1010)
Scottsdale
University of Arizona ( Site 1006)
Tucson
California
University of California San Diego ( Site 1002)
La Jolla
David Geffen School of Medicine at UCLA ( Site 1068)
Los Angeles
University of California Irvine ( Site 1086)
Orange
UC Davis - Medial Center ( Site 1064)
Sacramento
University of California San Francisco ( Site 1019)
San Francisco
Jeffrey S.Sager MD Medical Corporation ( Site 1060)
Santa Barbara
Harbor UCLA Medical Center ( Site 1028)
Torrance
Colorado
University of Colorado Hospital ( Site 1013)
Aurora
Washington, D.c.
The George Washington University Medical Faculty Associates ( Site 1025)
Washington D.c.
Florida
Mayo Clinic Jacksonville - PPDS ( Site 1045)
Jacksonville
AdventHealth Orlando ( Site 1058)
Orlando
University of South Florida ( Site 1043)
Tampa
Georgia
Emory University ( Site 1030)
Atlanta
Iowa
University of Iowa Hospital and Clinics ( Site 1050)
Iowa City
Kentucky
Norton Pulmonary Specialists ( Site 1066)
Louisville
Massachusetts
Brigham & Women's Hospital ( Site 1014)
Boston
Tufts Medical Center - PPDS ( Site 1012)
Boston
Maryland
Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)
Baltimore
Michigan
University of Michigan ( Site 1011)
Ann Arbor
Minnesota
University of Minnesota ( Site 1062)
Minneapolis
Missouri
University of Kansas Medical Center ( Site 1020)
Kansas City
Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)
St Louis
North Carolina
The University of North Carolina at Chapel Hill ( Site 1042)
Chapel Hill
Duke University Medical Center ( Site 1026)
Durham
Nebraska
University of Nebraska Medical Center ( Site 1053)
Omaha
New Mexico
University of New Mexico Health Sciences Center ( Site 1048)
Albuquerque
Nevada
Renown Regional Medical Center ( Site 1055)
Reno
New York
New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)
New York
University of Rochester Medical Center - PPDS ( Site 1039)
Rochester
Ohio
The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)
Cincinnati
University of Cincinnati Medical Center ( Site 1035)
Cincinnati
Cleveland Clinic Foundation ( Site 1065)
Cleveland
The Ohio State University Wexner Medical Center ( Site 1032)
Columbus
Oklahoma
Integris Health, Inc. ( Site 1084)
Oklahoma City
Oregon
The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)
Portland
Pennsylvania
UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)
Pittsburgh
Rhode Island
Rhode Island Hospital ( Site 1033)
Providence
South Carolina
Medical University of South Carolina - PPDS ( Site 1003)
Mt. Pleasant
Tennessee
Statcare Pulmonary Consultants - Knoxville ( Site 1031)
Knoxville
Vanderbilt University Medical Center ( Site 1027)
Nashville
Texas
University of Texas Southwestern Medical Center ( Site 1038)
Dallas
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
Houston
Houston Methodist Hospital ( Site 1009)
Houston
Utah
University of Utah - PPDS ( Site 1049)
Salt Lake City
Washington
University of Washington Medical Center ( Site 1067)
Seattle
Wisconsin
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
Milwaukee
Other Locations
Argentina
Centro Medico Dra De Salvo ( Site 1904)
Buenos Aires
Hospital Universitario Austral ( Site 1901)
Buenos Aires
Cardiologia Palermo ( Site 1911)
Ciudad Autonoma De Buenos Aires
Instituto Médico DAMIC ( Site 1909)
Córdoba
Sanatorio Allende ( Site 1908)
Córdoba
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes
Instituto Medico Rio Cuarto ( Site 1907)
Río Cuarto
Centro Oncologico de Rosario ( Site 1905)
Rosario
Hospital Provincial del Centenario ( Site 1912)
Rosario
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario
Hospital Dr. Jose Maria Cullen ( Site 1902)
Santa Fe
Australia
Royal Adelaide Hospital ( Site 1109)
Adelaide
The Prince Charles Hospital ( Site 1104)
Brisbane
Royal Prince Alfred Hospital ( Site 1106)
Camperdown
Saint Vincents Hospital Sydney ( Site 1102)
Darlinghurst
Royal Hobart Hospital ( Site 1107)
Hobart
John Hunter Hospital ( Site 1101)
New Lambton
Fiona Stanley Hospital ( Site 1103)
Perth
Princess Alexandra Hospital ( Site 1108)
Woolloongabba
Austria
Medizinische Universität Graz ( Site 2003)
Graz
Medizinische Universitat Innsbruck ( Site 2004)
Innsbruck
Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
Linz
Medizinische Universitat Wien ( Site 2001)
Vienna
Belgium
Erasme Hospital ( Site 1402)
Brussels
UZ Leuven - Campus Gasthuisberg ( Site 1401)
Leuven
Brazil
Hospital Madre Teresa ( Site 1804)
Belo Horizonte
Hospital Dia do Pulmao ( Site 1802)
Blumenau
Hospital São Lucas da PUCRS ( Site 1801)
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)
Porto Alegre
Hospital Sao Paulo ( Site 1806)
São Paulo
Instituto do Coracao - HCFMUSP ( Site 1803)
São Paulo
Canada
Peter Lougheed Centre ( Site 2102)
Calgary
University of Alberta Hospital ( Site 2101)
Edmonton
St. Joseph's Healthcare Hamilton ( Site 2105)
Hamilton
Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
Montreal
St Boniface General Hospital ( Site 2106)
Winnepeg
Colombia
Fundacion Neumologica Colombiana ( Site 3403)
Bogota
Centro Medico Imbanaco de Cali S.A ( Site 3404)
Cali
Fundacion Valle del Lili ( Site 3401)
Cali
Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
Medellín
Croatia
Klinički Bolnički Centar Split ( Site 3901)
Split
Klinicki Bolnicki Centar Zagreb ( Site 3902)
Zagreb
Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus
Rigshospitalet ( Site 3802)
København Ø
France
CHU Angers ( Site 1313)
Angers
Hopital Cavale Blanche ( Site 1314)
Brest
Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)
Bron
CHU Caen Normandie ( Site 1325)
Caen
C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)
La Tronche
CHU - Hopital de Bicetre ( Site 1304)
Le Kremlin-bicêtre
CHRU Lille ( Site 1306)
Lille
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)
Montpellier
Hopital Nord Laennec ( Site 1309)
Nantes
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
Nice
Groupe Hospitalier Sud ( Site 1312)
Pessac
CHU de la Miletrie Poitiers ( Site 1316)
Poitiers
Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
Saint-priest-en-jarez
Hopital Civil - CHU Strasbourg ( Site 1307)
Strasbourg
CHU de Toulouse - Hopital Larrey ( Site 1315)
Toulouse
C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
Tours
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
Vandœuvre-lès-nancy
Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin
Universitätsklinik Köln ( Site 1511)
Cologne
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)
Dresden
Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
Giessen
Universitätsklinikum Halle ( Site 1502)
Halle
Medizinische Hochschule Hannover ( Site 1505)
Hanover
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
Heidelberg
Universataet des Saarlandes ( Site 1513)
Homburg
Universitatsklinikum Leipzig ( Site 1508)
Leipzig
Krankenhaus Neuwittelsbach ( Site 1510)
München
Universitaetsklinik Regensburg ( Site 1503)
Regensburg
Greece
Attikon University General Hospital of Athens ( Site 3604)
Athens
Evangelismos General Hospital of Athens ( Site 3605)
Athens
Onassis Cardiac Surgery Center ( Site 3602)
Athens
AHEPA University General Hospital of Thessaloniki ( Site 3601)
Thessaloniki
Israel
Assuta Ashdod Medical Center ( Site 1710)
Ashdod
Barzilai Medical Center ( Site 1708)
Ashkelon
Lady Davis Carmel Medical Center ( Site 1705)
Haifa
Hadassah Medical Center ( Site 1711)
Jerusalem
Meir Medical Center. ( Site 1707)
Kfar Saba
Rabin Medical Center ( Site 1703)
Petach Tikvah
Sheba MC ( Site 1701)
Ramat Gan
Italy
Ospedale S. Giuseppe Multimedica ( Site 2403)
Milan
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
Monza
Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407)
Napoli
Universita La Sapienza Policlinico Umberto I ( Site 2402)
Roma
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
Trieste
Mexico
Hospital Angeles Lomas ( Site 2501)
Huixquilucan
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
Mexico City
Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 2504)
Monterrey
Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)
Sertoma
Netherlands
VU Medisch Centrum ( Site 2601)
Amsterdam
Maastricht University Medical Center ( Site 2603)
Maastricht
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen
Erasmus MC ( Site 2604)
Rotterdam
New Zealand
Greenlane Clinical Centre ( Site 2703)
Auckland
Waikato District Health Board ( Site 2702)
Hamilton
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
Krakow
Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
Otwock
Portugal
Hospital Garcia de Orta ( Site 3501)
Almada
Centro Hospitalar E Universitário De Coimbra ( Site 3502)
Coimbra
Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503)
Lisbon
Republic of Korea
Chonnam National University Hospital ( Site 3105)
Gwangju
Gachon University Gil Medical Center ( Site 3103)
Incheon
Samsung Medical Center ( Site 3106)
Seoul
Seoul National University Hospital ( Site 3102)
Seoul
The Catholic University Seoul St. Mary's Hospital ( Site 3104)
Seoul
Serbia
Clinical Center of Serbia ( Site 2901)
Belgrade
Institute of Cardiovascular Diseases Dedinje ( Site 2903)
Belgrade
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Kamenitz
Clinical Center Kragujevac ( Site 2905)
Kragujevac
University Clinical Center Nis ( Site 2904)
Niš
Spain
Hospital Clinic de Barcelona ( Site 1602)
Barcelona
Hospital Universitari Vall d'Hebron ( Site 1605)
Barcelona
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid
Hospital Universitario La Paz ( Site 1610)
Madrid
Hospital Universitario Ramon y Cajal ( Site 1609)
Madrid
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
Majadahonda
Hospital Universitario de Son Espases ( Site 1611)
Palma De Mallorca
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
Salamanca
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander
Hospital Universitario de Toledo ( Site 1607)
Toledo
Sweden
Sahlgrenska Universitetssjukhuset ( Site 3201)
Gothenburg
Skanes Universitetssjukhus Lund ( Site 3203)
Lund
Norrlands Universitetssjukhus ( Site 3205)
Umeå
Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)
Uppsala
Switzerland
Universitaetsspital Zurich ( Site 3301)
Zurich
Taiwan
Kaohsiung Veterans General Hospital ( Site 3702)
Kaohsiung City
China Medical University Hospital ( Site 3701)
Taichung
National Cheng Kung University Hospital ( Site 3703)
Tainan
United Kingdom
Royal Papworth Hospital ( Site 1208)
Cambridge
Golden Jubilee National Hospital ( Site 1204)
Glasgow
Imperial College Healthcare NHS Trust ( Site 1203)
London
Royal Brompton Hospital ( Site 1206)
London
Royal Free London NHS Foundation Trust ( Site 1202)
London
The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)
Newcastle Upon Tyne
Royal Hallamshire Hospital ( Site 1207)
Sheffield
Time Frame
Start Date: 2021-05-12
Completion Date: 2026-02-27
Participants
Target number of participants: 815
Treatments
Experimental: Sotatercept Treatment
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection for Visit 1. Dose will escalate to 0.7 mg/kg SC injection at Visit 2 through the remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and, if at a dose \<0.7 mg/kg SC injection, can titrate up to 0.7 mg/kg SC injection for the remainder of the study.
Related Therapeutic Areas
Sponsors
Leads: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

This content was sourced from clinicaltrials.gov