A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12) (SOTERIA)

April 5, 2024 updated by: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants eligible to enroll in the study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, B1629AHJ
        • Recruiting
        • Hospital Universitario Austral ( Site 1901)
        • Contact:
          • Study Coordinator
          • Phone Number: +5491160149487
      • Cordoba, Argentina, X5000JHQ
        • Recruiting
        • Sanatorio Allende ( Site 1908)
        • Contact:
          • Study Coordinator
          • Phone Number: +543514250526
      • Santa Fe, Argentina, S3000EOZ
        • Recruiting
        • Hospital Dr. Jose Maria Cullen ( Site 1902)
        • Contact:
          • Study Coordinator
          • Phone Number: +543424528250
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425BNG
        • Recruiting
        • Cardiologia Palermo ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: +541148339060
      • Quilmes, Buenos Aires, Argentina, 1878
        • Recruiting
        • Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
        • Contact:
          • Study Coordinator
          • Phone Number: +541142531337
    • Caba
      • Ciudad Autonoma de Buenos Aires, Caba, Argentina, C1426ABP
        • Recruiting
        • Centro Medico Dra De Salvo ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +541147815331
    • Cordoba
      • Córdoba, Cordoba, Argentina, 5003DCE
        • Recruiting
        • Instituto Médico DAMIC ( Site 1909)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 351 4888230
      • Rio Cuarto, Cordoba, Argentina, X5800AEV
        • Recruiting
        • Instituto Medico Rio Cuarto ( Site 1907)
        • Contact:
          • Study Coordinator
          • Phone Number: +543584679333
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2002
        • Recruiting
        • Hospital Provincial del Centenario ( Site 1912)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414375807
      • Rosario, Santa Fe, Argentina, S2000DSR
        • Recruiting
        • Instituto Cardiovascular de Rosario ( Site 1906)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414203040
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Recruiting
        • Centro Oncologico de Rosario ( Site 1905)
        • Contact:
          • Study Coordinator
          • Phone Number: +543414268409
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: +61295199669
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • Saint Vincents Hospital Sydney ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +61283823785
      • New Lambton, New South Wales, Australia, 2305
        • Recruiting
        • John Hunter Hospital ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +61249214095
    • Queensland
      • Brisbane, Queensland, Australia, 4032
        • Recruiting
        • The Prince Charles Hospital ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +61738769033
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Princess Alexandra Hospital ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: +61731765145
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital ( Site 1109)
        • Contact:
          • Study Coordinator
          • Phone Number: +61870745244
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Royal Hobart Hospital ( Site 1107)
        • Contact:
          • Study Coordinator
          • Phone Number: +61361668308
    • Western Australia
      • Perth, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital ( Site 1103)
        • Contact:
          • Study Coordinator
          • Phone Number: +61861511154
  • Austria
      • Wien, Austria, 1090
        • Recruiting
        • Medizinische Universitat Wien ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: +4314040043910
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
        • Contact:
          • Study Coordinator
          • Phone Number: +4373276764916
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Completed
        • Medizinische Universität Graz ( Site 2003)
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Recruiting
        • Medizinische Universitat Innsbruck ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: +4351250481413
  • Belgium
    • Bruxelles-Capitale, Region De
      • Bruxelles, Bruxelles-Capitale, Region De, Belgium, 1070
        • Recruiting
        • Erasme Hospital ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +3225553111
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven - Campus Gasthuisberg ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +3216341245
  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Instituto do Coracao - HCFMUSP ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +551126615797
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30430-142
        • Recruiting
        • Hospital Madre Teresa ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +553133398115
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
        • Recruiting
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +555132148143
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Recruiting
        • Hospital São Lucas da PUCRS ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +555133205010
    • Santa Catarina
      • Blumenau, Santa Catarina, Brazil, 89010-000
        • Recruiting
        • Hospital Dia do Pulmao ( Site 1802)
        • Contact:
          • Study Coordinator
          • Phone Number: +554730377099
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 04038-031
        • Recruiting
        • Hospital Sao Paulo ( Site 1806)
        • Contact:
          • Study Coordinator
          • Phone Number: +551155792581
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Recruiting
        • University of Alberta Hospital ( Site 2101)
        • Contact:
          • Study Coordinator
          • Phone Number: 7804071586
    • Manitoba
      • Winnepeg, Manitoba, Canada, R2H 2A6
        • Recruiting
        • St Boniface General Hospital ( Site 2106)
        • Contact:
          • Study Coordinator
          • Phone Number: 2042338563
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1A6
        • Recruiting
        • St. Joseph's Healthcare Hamilton ( Site 2105)
        • Contact:
          • Study Coordinator
          • Phone Number: 9055221155
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
        • Contact:
          • Study Coordinator
          • Phone Number: 5143407531
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 50034
        • Recruiting
        • Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
        • Contact:
          • Study Coordinator
          • Phone Number: +573137963442
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia, 110131
        • Recruiting
        • Fundacion Neumologica Colombiana ( Site 3403)
        • Contact:
          • Study Coordinator
          • Phone Number: +5717428914
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 760032
        • Recruiting
        • Fundacion Valle del Lili ( Site 3401)
        • Contact:
          • Study Coordinator
          • Phone Number: +573155006300
      • Santiago de Cali, Valle Del Cauca, Colombia, 760042
        • Recruiting
        • Centro Medico Imbanaco de Cali S.A ( Site 3404)
        • Contact:
          • Study Coordinator
          • Phone Number: +573138534831
  • Croatia
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Recruiting
        • Klinički Bolnički Centar Split ( Site 3901)
        • Contact:
          • Study Coordinator
          • Phone Number: +385 021556129
    • Zagrebacka Zupanija
      • Zagreb, Zagrebacka Zupanija, Croatia, 10000
        • Recruiting
        • Klinicki Bolnicki Centar Zagreb ( Site 3902)
        • Contact:
          • Study Coordinator
          • Phone Number: +38512385283
  • Czechia
      • Praha 2, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)
        • Contact:
          • Study Coordinator
          • Phone Number: +420224967066
      • Praha 4, Czechia, 140 21
        • Recruiting
        • Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: +420261363387
  • Denmark
    • Hovedstaden
      • København Ø, Hovedstaden, Denmark, 2100
        • Recruiting
        • Rigshospitalet ( Site 3802)
        • Contact:
          • Study Coordinator
          • Phone Number: +4535457752
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus Universitetshospital, Skejby ( Site 3801)
        • Contact:
          • Study Coordinator
          • Phone Number: +4578450000
  • France
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: +33492038570
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67000
        • Recruiting
        • Hopital Civil - CHU Strasbourg ( Site 1307)
        • Contact:
          • Study Coordinator
          • Phone Number: +33369550345
    • Calvados
      • Caen, Calvados, France, 14000
        • Recruiting
        • Hopital cote de Nacre ( Site 1325)
        • Contact:
          • Study Coordinator
          • Phone Number: +33231064677
    • Finistere
      • Brest, Finistere, France, 29200
        • Recruiting
        • Hopital Cavale Blanche ( Site 1314)
        • Contact:
          • Study Coordinator
          • Phone Number: +33298347600
    • Gironde
      • Pessac, Gironde, France, 33600
        • Recruiting
        • Groupe Hospitalier Sud ( Site 1312)
        • Contact:
          • Study Coordinator
          • Phone Number: +33557656439
    • Haute-Garonne
      • Toulouse, Haute-Garonne, France, 31059
        • Recruiting
        • CHU de Toulouse - Hopital Larrey ( Site 1315)
        • Contact:
          • Study Coordinator
          • Phone Number: +33567771793
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +33467335937
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37000
        • Recruiting
        • C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
        • Contact:
          • Study Coordinator
          • Phone Number: +33247473714
    • Isere
      • La Tronche, Isere, France, 38700
        • Recruiting
        • C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +33664810986
    • Loire
      • Saint-Priest-en-Jarez, Loire, France, 42270
        • Recruiting
        • Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +33477828070
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • Recruiting
        • Hopital Nord Laennec ( Site 1309)
        • Contact:
          • Study Coordinator
          • Phone Number: +33240165235
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Recruiting
        • CHU Angers ( Site 1313)
        • Contact:
          • Study Coordinator
          • Phone Number: +33241354769
    • Meurthe-et-Moselle
      • Vandoeuvre Les Nancy, Meurthe-et-Moselle, France, 54500
        • Recruiting
        • C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
        • Contact:
          • Study Coordinator
          • Phone Number: +33383154405
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • CHRU Lille ( Site 1306)
        • Contact:
          • Study Coordinator
          • Phone Number: +33320446011
    • Rhone-Alpes
      • Bron, Rhone-Alpes, France, 69677
        • Recruiting
        • Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)
        • Contact:
          • Study Coordinator
          • Phone Number: +33472681301
    • Val-de-Marne
      • Le Kremlin Bicetre, Val-de-Marne, France, 94270
        • Recruiting
        • CHU - Hopital de Bicetre ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +33145212121
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Recruiting
        • CHU de la Miletrie Poitiers ( Site 1316)
        • Contact:
          • Study Coordinator
          • Phone Number: +33549444689
  • Germany
      • Berlin, Germany, 14050
        • Recruiting
        • DRK Kliniken Berlin Westend ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +493030350
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Recruiting
        • Thoraxklinik-Heidelberg gGmbH ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +4962213968053
    • Bayern
      • München, Bayern, Germany, 80639
        • Recruiting
        • Krankenhaus Neuwittelsbach ( Site 1510)
        • Contact:
          • Study Coordinator
          • Phone Number: +498913042205
      • Regensburg, Bayern, Germany, 93053
        • Recruiting
        • Universitaetsklinik Regensburg ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +499419444489
    • Hessen
      • Gießen, Hessen, Germany, 35392
        • Recruiting
        • Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
        • Contact:
          • Study Coordinator
          • Phone Number: +496419945113
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +495115329184
    • Nordrhein-Westfalen
      • Cologne, Nordrhein-Westfalen, Germany, 50931
        • Recruiting
        • Universitätsklinik Köln ( Site 1511)
        • Contact:
          • Study Coordinator
          • Phone Number: +492214785860
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Recruiting
        • Universataet des Saarlandes ( Site 1513)
        • Contact:
          • Study Coordinator
          • Phone Number: +4968411621328
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: +493514585089
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitatsklinikum Leipzig ( Site 1508)
        • Contact:
          • Study Coordinator
          • Phone Number: +493419725052
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Recruiting
        • Universitätsklinikum Halle ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +493455572622
  • Greece
      • Thessaloniki, Greece, 546 36
        • Recruiting
        • AHEPA University General Hospital of Thessaloniki ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: +302310993261
    • Attiki
      • Athens, Attiki, Greece, 124 62
        • Recruiting
        • Attikon University General Hospital of Athens ( Site 3604)
        • Contact:
          • Study Coordinator
          • Phone Number: +306945468736
      • Athens, Attiki, Greece, 176 74
        • Recruiting
        • Onassis Cardiac Surgery Center ( Site 3602)
        • Contact:
          • Study Coordinator
          • Phone Number: +302109493341
      • Athina, Attiki, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital of Athens ( Site 3605)
        • Contact:
          • Study Coordinator
          • Phone Number: +302107201211
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Ashdod Medical Center ( Site 1710)
        • Contact:
          • Study Coordinator
          • Phone Number: +972507777618
      • Ashkelon, Israel, 7830604
        • Recruiting
        • Barzilai Medical Center ( Site 1708)
        • Contact:
          • Study Coordinator
          • Phone Number: +97286712931
      • Haifa, Israel, 3436212
        • Recruiting
        • Lady Davis Carmel Medical Center ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: +97248342707
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 1711)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226777595
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Meir Medical Center ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: +97297472555
      • Petach Tikvah, Israel, 49100
        • Recruiting
        • Rabin Medical Center ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239231437
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba MC ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235343888
  • Italy
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407)
        • Contact:
          • Study Coordinator
          • Phone Number: +390817061111
      • Roma, Italy, 00161
        • Recruiting
        • Universita "La Sapienza" Policlinico Umberto I ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +390649979051
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34149
        • Recruiting
        • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 040 399 1111
    • Lombardia
      • Milano, Lombardia, Italy, 20123
        • Recruiting
        • Ospedale S. Giuseppe Multimedica ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +390285991
      • Monza, Lombardia, Italy, 20900
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: +390392331
  • Korea, Republic of
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center ( Site 3103)
        • Contact:
          • Study Coordinator
          • Phone Number: +82324603663
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: +821091601357
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center ( Site 3106)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234103892
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • The Catholic University Seoul St. Mary's Hospital ( Site 3104)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222586007
    • Kyonggi-do
      • Gwangju, Kyonggi-do, Korea, Republic of, 61469
        • Recruiting
        • Chonnam National University Hospital ( Site 3105)
        • Contact:
          • Study Coordinator
          • Phone Number: +82622205114
  • Mexico
      • Huixquilucan, Mexico, 52763
        • Recruiting
        • Hospital Angeles Lomas ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: +525552470671
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: +528888888888
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Recruiting
        • Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: +528183467800
      • Sertoma, Nuevo Leon, Mexico, 64718
        • Recruiting
        • Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)
        • Contact:
          • Study Coordinator
          • Phone Number: +528181430795
  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Recruiting
        • Radboud University Nijmegen Medical Centre ( Site 2605)
        • Contact:
          • Study Coordinator
          • Phone Number: +31243616928
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht University Medical Center ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +31433871049
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • Recruiting
        • VU Medisch Centrum ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: +31204444444
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GJ
        • Recruiting
        • Erasmus MC ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +31107033612
  • New Zealand
      • Auckland, New Zealand, 1051
        • Recruiting
        • Greenlane Clinical Centre ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: +6496389909
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Recruiting
        • Waikato District Health Board ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: +6478599180
  • Poland
    • Malopolskie
      • Krakow, Malopolskie, Poland, 31-202
        • Recruiting
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: +48126143501
    • Mazowieckie
      • Otwock, Mazowieckie, Poland, 05-400
        • Recruiting
        • Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +48227103010
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Centro Hospitalar E Universitário De Coimbra ( Site 3502)
        • Contact:
          • Study Coordinator
          • Phone Number: +351239400400
      • Lisboa, Portugal, 1769-001
        • Recruiting
        • Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503)
        • Contact:
          • Study Coordinator
          • Phone Number: +351217548085
    • Setubal
      • Almada, Setubal, Portugal, 2801-951
        • Recruiting
        • Hospital Garcia de Orta ( Site 3501)
        • Contact:
          • Study Coordinator
          • Phone Number: +351212940294
  • Serbia
      • Beograd, Serbia, 11000
        • Recruiting
        • Clinical Center of Serbia ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: +381112685662
      • Beograd, Serbia, 11040
        • Recruiting
        • Institute of Cardiovascular Diseases Dedinje ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: +381113601701
    • Juznobacki Okrug
      • Sremska kamenica, Juznobacki Okrug, Serbia, 21204
        • Recruiting
        • Institute for pulmonary diseases of Vojvodina ( Site 2906)
        • Contact:
          • Study Coordinator
          • Phone Number: +381214805100
    • Nisavski Okrug
      • Nis, Nisavski Okrug, Serbia, 18000
        • Recruiting
        • University Clinical Center Nis ( Site 2904)
        • Contact:
          • Study Coordinator
          • Phone Number: +38118333752
    • Sumadijski Okrug
      • Kragujevac, Sumadijski Okrug, Serbia, 34000
        • Recruiting
        • Clinical Center Kragujevac ( Site 2905)
        • Contact:
          • Study Coordinator
          • Phone Number: +38134370208
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932275786
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932742779
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914692313
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz ( Site 1610)
        • Contact:
          • Study Coordinator
          • Phone Number: +34917271785
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913368000
      • Salamanca, Spain, 37007
        • Completed
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
      • Toledo, Spain, 41007
        • Recruiting
        • Hospital Universitario de Toledo ( Site 1607)
        • Contact:
          • Study Coordinator
          • Phone Number: +34600162109
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +34942202569
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07120
        • Recruiting
        • Hospital Universitario de Son Espases ( Site 1611)
        • Contact:
          • Study Coordinator
          • Phone Number: +34871205110
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +34911917418
  • Sweden
    • Skane Lan
      • Lund, Skane Lan, Sweden, 22185
        • Completed
        • Skanes Universitetssjukhus Lund ( Site 3203)
    • Uppsala Lan
      • Uppsala, Uppsala Lan, Sweden, 751 85
        • Recruiting
        • Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)
        • Contact:
          • Study Coordinator
          • Phone Number: +46186110000
    • Vasterbottens Lan
      • Umea, Vasterbottens Lan, Sweden, 90185
        • Recruiting
        • Norrlands Universitetssjukhus ( Site 3205)
        • Contact:
          • Study Coordinator
          • Phone Number: +4690785000
    • Vastra Gotalands Lan
      • Goteburg, Vastra Gotalands Lan, Sweden, 413 45
        • Recruiting
        • Sahlgrenska Universitetssjukhuset ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: +46313422929
  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitaetsspital Zurich ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: +41442551021
  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Recruiting
        • Kaohsiung Veterans General Hospital ( Site 3702)
        • Contact:
          • Study Coordinator
          • Phone Number: +88673468097
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital ( Site 3701)
        • Contact:
          • Study Coordinator
          • Phone Number: +886422052121
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 3703)
        • Contact:
          • Study Coordinator
          • Phone Number: +88663028130
  • United Kingdom
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: +441912137489
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
        • Recruiting
        • Royal Papworth Hospital ( Site 1208)
        • Contact:
          • Study Coordinator
          • Phone Number: +441480830541
    • England
      • London, England, United Kingdom, SW3 6HP
        • Recruiting
        • Royal Brompton Hospital ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: +442073518905
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G81 4HX
        • Recruiting
        • Golden Jubilee National Hospital ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +441419515497
    • London, City Of
      • London, London, City Of, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free London NHS Foundation Trust ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +442077940500
      • London, London, City Of, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare NHS Trust ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +441419515497
    • North Yorkshire
      • Sheffield, North Yorkshire, United Kingdom, S10 2JF
        • Recruiting
        • Royal Hallamshire Hospital ( Site 1207)
        • Contact:
          • Study Coordinator
          • Phone Number: +441142712566
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012-2369
        • Recruiting
        • Arizona Pulmonary Specialists ( Site 1010)
        • Contact:
          • Study Coordinator
          • Phone Number: 602-271-0832
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • Pulmonary Associates, PA ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: 602-258-4951
      • Tucson, Arizona, United States, 85724-0001
        • Recruiting
        • University of Arizona ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-626-8000
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: 858-657-7076
      • Los Angeles, California, United States, 90095
        • Recruiting
        • David Geffen School of Medicine at UCLA ( Site 1068)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-222-2467
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine ( Site 1086)
        • Contact:
          • Study Coordinator
          • Phone Number: 949-824-6256
      • Sacramento, California, United States, 95817-2201
        • Recruiting
        • UC Davis - Medial Center ( Site 1064)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-704-4000
      • San Francisco, California, United States, 94118
        • Recruiting
        • University of California San Francisco ( Site 1019)
        • Contact:
          • Study Coordinator
          • Phone Number: 415-353-1798
      • Santa Barbara, California, United States, 93105-5311
        • Recruiting
        • Jeffrey S.Sager MD Medical Corporation ( Site 1060)
        • Contact:
          • Study Coordinator
          • Phone Number: 805-845-1500
      • Torrance, California, United States, 90502-2006
        • Recruiting
        • Harbor UCLA Medical Center ( Site 1028)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-222-3560
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital ( Site 1013)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-2786
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Recruiting
        • The George Washington University Medical Faculty Associates ( Site 1025)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-741-3624
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville - PPDS ( Site 1045)
        • Contact:
          • Study Coordinator
          • Phone Number: 904-953-2232
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando ( Site 1058)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-303-7556
      • Tampa, Florida, United States, 33612
        • Recruiting
        • University of South Florida ( Site 1043)
        • Contact:
          • Study Coordinator
          • Phone Number: 813-259-0826
    • Georgia
      • Atlanta, Georgia, United States, 30322-1013
        • Recruiting
        • Emory University ( Site 1030)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-712-1370
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospital and Clinics ( Site 1050)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-356-2577
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Norton Pulmonary Specialists ( Site 1066)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-629-3102
    • Maryland
      • Baltimore, Maryland, United States, 21206
        • Recruiting
        • Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-955-6337
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham & Women's Hospital ( Site 1014)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-525-1267
      • Boston, Massachusetts, United States, 02111-1526
        • Recruiting
        • Tufts Medical Center - PPDS ( Site 1012)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-636-2892
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan ( Site 1011)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-232-3741
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota ( Site 1062)
        • Contact:
          • Study Coordinator
          • Phone Number: 612-827-1131
    • Missouri
      • Kansas City, Missouri, United States, 66160
        • Recruiting
        • University of Kansas Medical Center ( Site 1020)
        • Contact:
          • Study Coordinator
          • Phone Number: 913-588-2314
      • Saint Louis, Missouri, United States, 63108-1495
        • Recruiting
        • Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-454-8766
    • Nebraska
      • Omaha, Nebraska, United States, 68118
        • Recruiting
        • University of Nebraska Medical Center ( Site 1053)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-559-7182
    • Nevada
      • Reno, Nevada, United States, 89502-1262
        • Active, not recruiting
        • Renown Regional Medical Center ( Site 1055)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico Health Sciences Center ( Site 1048)
        • Contact:
          • Study Coordinator
          • Phone Number: 505-272-1129
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-305-4436
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center - PPDS ( Site 1039)
        • Contact:
          • Study Coordinator
          • Phone Number: 585-275-7434
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • The University of North Carolina at Chapel Hill ( Site 1042)
        • Contact:
          • Study Coordinator
          • Phone Number: 984-974-8236
      • Durham, North Carolina, United States, 27710-4000
        • Recruiting
        • Duke University Medical Center ( Site 1026)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-668-2642
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center ( Site 1035)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-558-3975
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-585-1777
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • The Ohio State University Wexner Medical Center ( Site 1032)
        • Contact:
          • Study Coordinator
          • Phone Number: 614-688-6687
      • Twinsburg, Ohio, United States, 44087
        • Recruiting
        • Cleveland Clinic Foundation ( Site 1065)
        • Contact:
          • Study Coordinator
          • Phone Number: 216-444-6814
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112-4492
        • Recruiting
        • Integris Health, Inc. ( Site 1084)
        • Contact:
          • Study Coordinator
          • Phone Number: 405-945-4805
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)
        • Contact:
          • Study Coordinator
          • Phone Number: 503-297-3778
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)
        • Contact:
          • Study Coordinator
          • Phone Number: 412-623-4147
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital ( Site 1033)
        • Contact:
          • Study Coordinator
          • Phone Number: 401-444-0369
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464-3771
        • Recruiting
        • Medical University of South Carolina - PPDS ( Site 1003)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-792-3162
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Recruiting
        • Statcare Pulmonary Consultants - Knoxville ( Site 1031)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-924-9800
      • Nashville, Tennessee, United States, 37232-0011
        • Recruiting
        • Vanderbilt University Medical Center ( Site 1027)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-322-6512
    • Texas
      • Dallas, Texas, United States, 78701
        • Recruiting
        • University of Texas Southwestern Medical Center ( Site 1038)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-645-5989
      • Houston, Texas, United States, 77030
        • Recruiting
        • CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
        • Contact:
          • Study Coordinator
          • Phone Number: 832-355-1000
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital ( Site 1009)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-790-3333
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah - PPDS ( Site 1049)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-581-3693
    • Washington
      • Seattle, Washington, United States, 98195-0001
        • Recruiting
        • University of Washington Medical Center ( Site 1067)
        • Contact:
          • Study Coordinator
          • Phone Number: 206-598-4477
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-6444

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Did not participate in a sotatercept PAH parent trial
  • 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 (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
  • Pregnant or breastfeeding females

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sotatercept Treatment
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose < 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
Biological: Sotatercept
Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.
Other Names:
  • ACE-011
  • MK-7962

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 50 months
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who experience an AE will be reported.
Up to approximately 50 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 50 months
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 50 months
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
Time Frame: Up to approximately 50 months
ADAs will be detected in serum. The number of participants with detectable ADAs will be presented.
Up to approximately 50 months
Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
Time Frame: Up to approximately 50 months
Blood samples will be collected to determine concentration of red blood cell count, white blood cell count, platelet count, hemoglobin and hematocrit at designated timepoints up to approximately 50 months.
Up to approximately 50 months
Laboratory parameters (Serum Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
Time Frame: Up to approximately 50 months
Blood samples will be collected to determine concentration of blood urea, creatinine, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP, sodium, potassium, chloride, calcium, phosphorous, glucose, magnesium, carbon dioxide, and albumin at designated time points for up to approximately 50 months.
Up to approximately 50 months
Laboratory parameter: Concentration of Follicle Stimulating Hormone (FSH)
Time Frame: Up to approximately 50 months
Blood samples will be collected to determine concentration of FSH level at designated time points up to approximately 50 months.
Up to approximately 50 months
Change From Baseline in Body Weight
Time Frame: Baseline and up to approximately 48 months
Change from baseline in body weight will be reported at designated time points up to approximately 48 months.
Baseline and up to approximately 48 months
Change From Baseline in Blood Pressure
Time Frame: Baseline and up to approximately 48 months
Change from baseline in systolic and diastolic blood pressure will be reported at designated time points up to approximately 48 months.
Baseline and up to approximately 48 months
Change From Baseline in Electrocardiogram (ECG)
Time Frame: Baseline and up to approximately 48 months
Change from baseline in ECG (12-lead) for the determination of QTcF interval will be reported at designated time points up to approximately 48 months.
Baseline and up to approximately 48 months
Laboratory parameters (Urinalysis): pH, Specific Gravity, Protein, Glucose, Bilirubin, Ketones, Blood, Leukocyte Esterase, Urobilinogen, and Nitrite
Time Frame: Up to approximately 48 months
Urine samples will be collected to determine pH, specific gravity, protein, glucose, bilirubin, ketones, blood, leukocyte esterase, urobilinogen, and nitrite at designated timepoints up to approximately 48 months.
Up to approximately 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 6-Minute Walk Distance (6MWD)
Time Frame: Baseline and up to approximately 48 months
The 6MWD was the distance walked in 6 minutes as a measure of functional capacity. This was assessed using the 6-minute walk test (6MWT). The change from baseline in 6MWD will be reported.
Baseline and up to approximately 48 months
Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels
Time Frame: Baseline and up to approximately 48 months
NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP level will be reported.
Baseline and up to approximately 48 months
Change From Baseline in the Percentage of Participants Who Improve in modified New York Heart Association (NYHA)/ World Health Organization classification of functional status (WHO FC)
Time Frame: Baseline and up to approximately 48 months
The severity of participant's pulmonary arterial hypertension (PAH) symptoms will be graded using the WHO FC system. WHO functional classification for PAH ranges from Class I (no limitation in physical activity, no dyspnea with normal activity), Class II (slight limitation of physical activity), Class III (marked limitation of physical activity) and Class IV (cannot perform a physical activity without any symptoms, dyspnea at rest). Participants who improve in WHO FC were classified into "Improved", "No change" and "Worsened". Improvement = reduction in FC, worsened = increase in FC and no change = no change in FC. The change from baseline in the percentage of participants who improve in WHO FC will be reported.
Baseline and up to approximately 48 months
Change From Baseline in Pulmonary Vascular Resistance (PVR)
Time Frame: Baseline and up to approximately 48 months
PVR is a hemodynamic variable of pulmonary circulation and was measured by right heart catheterization (RHC). The change from baseline in PVR will be reported.
Baseline and up to approximately 48 months
Overall Survival (OS)
Time Frame: Up to approximately 78 months
Overall survival is defined as the time from the start of the first sotatercept treatment in the individual participant's parent study or in this study, if the participant was completely on placebo in the parent study, to the date of death in this study, regardless of the actual cause of the participant's death.
Up to approximately 78 months
Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator
Time Frame: Baseline and up to approximately 48 months
The simplified French risk scoring system was based on the 2015 European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines for the diagnosis and treatment of pulmonary hypertension (PH). In this study, the noninvasive parameters were used to determine the score. 'Low risk' was defined as attaining or maintaining all 3 low-risk criteria: WHO FC I or II, 6MWD > 440 m, and NT-proBNP <300 ng/L. The change from baseline in percentage of participants who maintained or achieved a low risk score using the simplified French risk score calculator will be reported.
Baseline and up to approximately 48 months
Change From Baseline in Borg Dyspnea Scale Category Ratio 10 (Borg CR 10) Score
Time Frame: Baseline and up to approximately 48 months
The Borg CR 10 Scale assesses the severity of shortness of breath as perceived by the participant. Participants will be asked: How much difficulty is your breathing causing you right now?". The score of the item ranges from 0 (no difficulty in breathing) to10 (maximum difficulty in breathing). Higher score indicates more severe dyspnea. The change from baseline in Borg CR10 scale score will be reported.
Baseline and up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

November 30, 2027

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7962-004
  • A011-12 (Other Identifier: Acceleronpharma)
  • 2020-005061-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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