A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)
NCT ID: NCT04796337
Last Updated: 2025-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
815 participants
INTERVENTIONAL
2021-05-12
2026-02-27
Brief Summary
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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.
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Detailed Description
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Participants enrolled in this study may be eligible to participate in MK-7962-038 (NCT number pending), an open-label LTFU study to evaluate the effects of sotatercept when added to background PAH therapy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Sotatercept
Sotatercept SC injection at a dose of 0.3 to 0.7 mg/kg.
Interventions
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Sotatercept
Sotatercept SC injection at a dose of 0.3 to 0.7 mg/kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Pulmonary Associates, PA ( Site 1008)
Phoenix, Arizona, United States
Arizona Pulmonary Specialists ( Site 1010)
Scottsdale, Arizona, United States
University of Arizona ( Site 1006)
Tucson, Arizona, United States
University of California San Diego ( Site 1002)
La Jolla, California, United States
David Geffen School of Medicine at UCLA ( Site 1068)
Los Angeles, California, United States
University of California Irvine ( Site 1086)
Orange, California, United States
UC Davis - Medial Center ( Site 1064)
Sacramento, California, United States
University of California San Francisco ( Site 1019)
San Francisco, California, United States
Jeffrey S.Sager MD Medical Corporation ( Site 1060)
Santa Barbara, California, United States
Harbor UCLA Medical Center ( Site 1028)
Torrance, California, United States
University of Colorado Hospital ( Site 1013)
Aurora, Colorado, United States
The George Washington University Medical Faculty Associates ( Site 1025)
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville - PPDS ( Site 1045)
Jacksonville, Florida, United States
AdventHealth Orlando ( Site 1058)
Orlando, Florida, United States
University of South Florida ( Site 1043)
Tampa, Florida, United States
Emory University ( Site 1030)
Atlanta, Georgia, United States
University of Iowa Hospital and Clinics ( Site 1050)
Iowa City, Iowa, United States
Norton Pulmonary Specialists ( Site 1066)
Louisville, Kentucky, United States
Johns Hopkins Pulmonary and Critical Care Medicine ( Site 1036)
Baltimore, Maryland, United States
Tufts Medical Center - PPDS ( Site 1012)
Boston, Massachusetts, United States
Brigham & Women's Hospital ( Site 1014)
Boston, Massachusetts, United States
University of Michigan ( Site 1011)
Ann Arbor, Michigan, United States
University of Minnesota ( Site 1062)
Minneapolis, Minnesota, United States
University of Kansas Medical Center ( Site 1020)
Kansas City, Missouri, United States
Barnes-Jewish Hospital Center for Outpatient Health ( Site 1022)
St Louis, Missouri, United States
University of Nebraska Medical Center ( Site 1053)
Omaha, Nebraska, United States
Renown Regional Medical Center ( Site 1055)
Reno, Nevada, United States
University of New Mexico Health Sciences Center ( Site 1048)
Albuquerque, New Mexico, United States
New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 1046)
New York, New York, United States
University of Rochester Medical Center - PPDS ( Site 1039)
Rochester, New York, United States
The University of North Carolina at Chapel Hill ( Site 1042)
Chapel Hill, North Carolina, United States
Duke University Medical Center ( Site 1026)
Durham, North Carolina, United States
The Lindner Center for Research and Education at The Christ Hospital ( Site 1001)
Cincinnati, Ohio, United States
University of Cincinnati Medical Center ( Site 1035)
Cincinnati, Ohio, United States
Cleveland Clinic Foundation ( Site 1065)
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center ( Site 1032)
Columbus, Ohio, United States
Integris Health, Inc. ( Site 1084)
Oklahoma City, Oklahoma, United States
The Oregon Clinic Pulmonary, Critical Care and Sleep Medicine - West ( Site 1054)
Portland, Oregon, United States
UPMC Presbyterian. UPMC Presbyterian Hospital ( Site 1059)
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital ( Site 1033)
Providence, Rhode Island, United States
Medical University of South Carolina - PPDS ( Site 1003)
Mt. Pleasant, South Carolina, United States
Statcare Pulmonary Consultants - Knoxville ( Site 1031)
Knoxville, Tennessee, United States
Vanderbilt University Medical Center ( Site 1027)
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center ( Site 1038)
Dallas, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center ( Site 1044)
Houston, Texas, United States
Houston Methodist Hospital ( Site 1009)
Houston, Texas, United States
University of Utah - PPDS ( Site 1049)
Salt Lake City, Utah, United States
University of Washington Medical Center ( Site 1067)
Seattle, Washington, United States
Froedtert Hospital & the Medical College of Wisconsin ( Site 1051)
Milwaukee, Wisconsin, United States
Cardiologia Palermo ( Site 1911)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes ( Site 1903)
Quilmes, Buenos Aires, Argentina
Centro Medico Dra De Salvo ( Site 1904)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Médico DAMIC ( Site 1909)
Córdoba, Córdoba Province, Argentina
Instituto Medico Rio Cuarto ( Site 1907)
Río Cuarto, Córdoba Province, Argentina
Hospital Provincial del Centenario ( Site 1912)
Rosario, Santa Fe Province, Argentina
Instituto Cardiovascular de Rosario ( Site 1906)
Rosario, Santa Fe Province, Argentina
Centro Oncologico de Rosario ( Site 1905)
Rosario, Santa Fe Province, Argentina
Hospital Universitario Austral ( Site 1901)
Buenos Aires, , Argentina
Sanatorio Allende ( Site 1908)
Córdoba, , Argentina
Hospital Dr. Jose Maria Cullen ( Site 1902)
Santa Fe, , Argentina
Royal Prince Alfred Hospital ( Site 1106)
Camperdown, New South Wales, Australia
Saint Vincents Hospital Sydney ( Site 1102)
Darlinghurst, New South Wales, Australia
John Hunter Hospital ( Site 1101)
New Lambton, New South Wales, Australia
The Prince Charles Hospital ( Site 1104)
Brisbane, Queensland, Australia
Princess Alexandra Hospital ( Site 1108)
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital ( Site 1109)
Adelaide, South Australia, Australia
Royal Hobart Hospital ( Site 1107)
Hobart, Tasmania, Australia
Fiona Stanley Hospital ( Site 1103)
Perth, Western Australia, Australia
Medizinische Universität Graz ( Site 2003)
Graz, Styria, Austria
Medizinische Universitat Innsbruck ( Site 2004)
Innsbruck, Tyrol, Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 2002)
Linz, Upper Austria, Austria
Medizinische Universitat Wien ( Site 2001)
Vienna, , Austria
Erasme Hospital ( Site 1402)
Brussels, Bruxelles-Capitale, Region de, Belgium
UZ Leuven - Campus Gasthuisberg ( Site 1401)
Leuven, Vlaams-Brabant, Belgium
Hospital Madre Teresa ( Site 1804)
Belo Horizonte, Minas Gerais, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 1805)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital São Lucas da PUCRS ( Site 1801)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Dia do Pulmao ( Site 1802)
Blumenau, Santa Catarina, Brazil
Hospital Sao Paulo ( Site 1806)
São Paulo, São Paulo, Brazil
Instituto do Coracao - HCFMUSP ( Site 1803)
São Paulo, , Brazil
Peter Lougheed Centre ( Site 2102)
Calgary, Alberta, Canada
University of Alberta Hospital ( Site 2101)
Edmonton, Alberta, Canada
St Boniface General Hospital ( Site 2106)
Winnepeg, Manitoba, Canada
St. Joseph's Healthcare Hamilton ( Site 2105)
Hamilton, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital ( Site 2103)
Montreal, Quebec, Canada
Centro Cardiovascular Colombiano Clínica Santa María Clínica Cardio VID ( Site 3402)
Medellín, Antioquia, Colombia
Fundacion Neumologica Colombiana ( Site 3403)
Bogota, Cundinamarca, Colombia
Fundacion Valle del Lili ( Site 3401)
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 3404)
Cali, Valle del Cauca Department, Colombia
Klinički Bolnički Centar Split ( Site 3901)
Split, Split-Dalmatia County, Croatia
Klinicki Bolnicki Centar Zagreb ( Site 3902)
Zagreb, Zagreb County, Croatia
Vseobecna fakultni nemocnice v Praze-Centrum srdečního selhání ( Site 2201)
Prague, , Czechia
Institut klinicke a experimentalni mediciny (IKEM) ( Site 2202)
Prague, , Czechia
Rigshospitalet ( Site 3802)
København Ø, Capital Region, Denmark
Aarhus Universitetshospital, Skejby ( Site 3801)
Aarhus, Central Jutland, Denmark
Centre Hospitalier Universitaire de Nice - Hopital Pasteur ( Site 1311)
Nice, Alpes-Maritimes, France
Hôpital Louis Pradel - Service Endocrino, Diabeto, Nutrition ( Site 1317)
Bron, Auvergne-Rhône-Alpes, France
Hopital Civil - CHU Strasbourg ( Site 1307)
Strasbourg, Bas-Rhin, France
CHU Caen Normandie ( Site 1325)
Caen, Calvados, France
Hopital Cavale Blanche ( Site 1314)
Brest, Finistere, France
Groupe Hospitalier Sud ( Site 1312)
Pessac, Gironde, France
CHU de Toulouse - Hopital Larrey ( Site 1315)
Toulouse, Haute-Garonne, France
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1301)
Montpellier, Herault, France
C.H.U. de Tours - Hopital Bretonneau ( Site 1310)
Tours, Indre-et-Loire, France
C.H.U de Grenoble - Hopital Albert Michallon ( Site 1303)
La Tronche, Isere, France
Hopital Nord Laennec ( Site 1309)
Nantes, Loire-Atlantique, France
CHU Angers ( Site 1313)
Angers, Maine-et-Loire, France
C.H.U. de Nancy. Hopital de Brabois Adultes ( Site 1308)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHRU Lille ( Site 1306)
Lille, Nord, France
Centre Hospitalier Universitaire de Saint-Etienne ( Site 1302)
Saint-Priest-en-Jarez, Pays de la Loire Region, France
CHU - Hopital de Bicetre ( Site 1304)
Le Kremlin-Bicêtre, Val-de-Marne, France
CHU de la Miletrie Poitiers ( Site 1316)
Poitiers, Vienne, France
Thoraxklinik-Heidelberg gGmbH ( Site 1509)
Heidelberg, Baden-Wurttemberg, Germany
Krankenhaus Neuwittelsbach ( Site 1510)
München, Bavaria, Germany
Universitaetsklinik Regensburg ( Site 1503)
Regensburg, Bavaria, Germany
Universitätsklinikum Gießen und Marburg GmbH ( Site 1512)
Giessen, Hesse, Germany
Medizinische Hochschule Hannover ( Site 1505)
Hanover, Lower Saxony, Germany
Universitätsklinik Köln ( Site 1511)
Cologne, North Rhine-Westphalia, Germany
Universataet des Saarlandes ( Site 1513)
Homburg, Saarland, Germany
Universitaetsklinikum Carl Gustav Carus der TU Dresden ( Site 1501)
Dresden, Saxony, Germany
Universitatsklinikum Leipzig ( Site 1508)
Leipzig, Saxony, Germany
Universitätsklinikum Halle ( Site 1502)
Halle, Saxony-Anhalt, Germany
DRK Kliniken Berlin Westend ( Site 1507)
Berlin, , Germany
Evangelismos General Hospital of Athens ( Site 3605)
Athens, Attica, Greece
Attikon University General Hospital of Athens ( Site 3604)
Athens, Attica, Greece
Onassis Cardiac Surgery Center ( Site 3602)
Athens, Attica, Greece
AHEPA University General Hospital of Thessaloniki ( Site 3601)
Thessaloniki, , Greece
Assuta Ashdod Medical Center ( Site 1710)
Ashdod, , Israel
Barzilai Medical Center ( Site 1708)
Ashkelon, , Israel
Lady Davis Carmel Medical Center ( Site 1705)
Haifa, , Israel
Hadassah Medical Center ( Site 1711)
Jerusalem, , Israel
Meir Medical Center. ( Site 1707)
Kfar Saba, , Israel
Rabin Medical Center ( Site 1703)
Petach Tikvah, , Israel
Sheba MC ( Site 1701)
Ramat Gan, , Israel
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) ( Site 2405)
Trieste, Friuli Venezia Giulia, Italy
Ospedale S. Giuseppe Multimedica ( Site 2403)
Milan, Lombardy, Italy
Fondazione IRCCS San Gerardo dei Tintori - ASST di Monza - A. O. San Gerardo ( Site 2406)
Monza, Lombardy, Italy
Azienda Ospedaliera dei Colli V. Monaldi ( Site 2407)
Napoli, , Italy
Universita "La Sapienza" Policlinico Umberto I ( Site 2402)
Roma, , Italy
Instituto Nacional de Cardiologia Ignacio Chavez ( Site 2503)
Mexico City, Mexico City, Mexico
Hospital Universitario ""Dr. Jose Eleuterio Gonzalez"" ( Site 2504)
Monterrey, Nuevo León, Mexico
Unidad de Investigación Clínica en Medicina, S.C ( Site 2505)
Sertoma, Nuevo León, Mexico
Hospital Angeles Lomas ( Site 2501)
Huixquilucan, , Mexico
Radboud University Nijmegen Medical Centre ( Site 2605)
Nijmegen, Gelderland, Netherlands
Maastricht University Medical Center ( Site 2603)
Maastricht, Limburg, Netherlands
VU Medisch Centrum ( Site 2601)
Amsterdam, North Holland, Netherlands
Erasmus MC ( Site 2604)
Rotterdam, South Holland, Netherlands
Waikato District Health Board ( Site 2702)
Hamilton, Waikato Region, New Zealand
Greenlane Clinical Centre ( Site 2703)
Auckland, , New Zealand
Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 2801)
Krakow, Lesser Poland Voivodeship, Poland
Europejskie Centrum Zdrowia Otwock Szpital im Fryderyka Chopina ( Site 2802)
Otwock, Masovian Voivodeship, Poland
Hospital Garcia de Orta ( Site 3501)
Almada, Setúbal District, Portugal
Centro Hospitalar E Universitário De Coimbra ( Site 3502)
Coimbra, , Portugal
Centro Hospitalar Lisboa Norte E.P.E. - Hospital Pulido Valente ( Site 3503)
Lisbon, , Portugal
Clinical Center of Serbia ( Site 2901)
Belgrade, Beograd, Serbia
Institute of Cardiovascular Diseases Dedinje ( Site 2903)
Belgrade, Beograd, Serbia
Institute for pulmonary diseases of Vojvodina ( Site 2906)
Kamenitz, Juznobacki Okrug, Serbia
University Clinical Center Nis ( Site 2904)
Niš, Nisavski Okrug, Serbia
Clinical Center Kragujevac ( Site 2905)
Kragujevac, Sumadijski Okrug, Serbia
Chonnam National University Hospital ( Site 3105)
Gwangju, Kyonggi-do, South Korea
Gachon University Gil Medical Center ( Site 3103)
Incheon, , South Korea
Seoul National University Hospital ( Site 3102)
Seoul, , South Korea
Samsung Medical Center ( Site 3106)
Seoul, , South Korea
The Catholic University Seoul St. Mary's Hospital ( Site 3104)
Seoul, , South Korea
Hospital Universitario de Son Espases ( Site 1611)
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Marques de Valdecilla ( Site 1601)
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 1604)
Majadahonda, Madrid, Spain
Hospital Universitari Vall d'Hebron ( Site 1605)
Barcelona, , Spain
Hospital Clinic de Barcelona ( Site 1602)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 1603)
Madrid, , Spain
Hospital Universitario La Paz ( Site 1610)
Madrid, , Spain
Hospital Universitario Ramon y Cajal ( Site 1609)
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca ( Site 1608)
Salamanca, , Spain
Hospital Universitario de Toledo ( Site 1607)
Toledo, , Spain
Skanes Universitetssjukhus Lund ( Site 3203)
Lund, Skåne County, Sweden
Akademiska Sjukhuset [Uppsala, Sweden] ( Site 3204)
Uppsala, Uppsala County, Sweden
Norrlands Universitetssjukhus ( Site 3205)
Umeå, Västerbotten County, Sweden
Sahlgrenska Universitetssjukhuset ( Site 3201)
Gothenburg, Västra Götaland County, Sweden
Universitaetsspital Zurich ( Site 3301)
Zurich, , Switzerland
Kaohsiung Veterans General Hospital ( Site 3702)
Kaohsiung City, , Taiwan
China Medical University Hospital ( Site 3701)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 3703)
Tainan City, , Taiwan
Royal Papworth Hospital ( Site 1208)
Cambridge, Cambridgeshire, United Kingdom
Royal Brompton Hospital ( Site 1206)
London, England, United Kingdom
Golden Jubilee National Hospital ( Site 1204)
Glasgow, Glasgow City, United Kingdom
Royal Free London NHS Foundation Trust ( Site 1202)
London, London, City of, United Kingdom
Imperial College Healthcare NHS Trust ( Site 1203)
London, London, City of, United Kingdom
Royal Hallamshire Hospital ( Site 1207)
Sheffield, North Yorkshire, United Kingdom
The Newcastle Upon Tyne NHS Foundation Trust ( Site 1205)
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Preston IR, Badesch D, Ghofrani HA, Gibbs JSR, Gomberg-Maitland M, Hoeper MM, Humbert M, McLaughlin VV, Waxman AB, Manimaran S, Mikhailova E, Reddy M, Lau A, de Oliveira Pena J, Souza R. A long-term follow-up study of sotatercept for treatment of pulmonary arterial hypertension: interim results of SOTERIA. Eur Respir J. 2025 Jul 24;66(1):2401435. doi: 10.1183/13993003.01435-2024. Print 2025 Jul.
Related Links
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Merck Clinical Trials Information
Protocol Plain Language Summary
Other Identifiers
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A011-12
Identifier Type: OTHER
Identifier Source: secondary_id
MK-7962-004
Identifier Type: OTHER
Identifier Source: secondary_id
2023-509138-21-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1309-6218
Identifier Type: REGISTRY
Identifier Source: secondary_id
SOTERIA
Identifier Type: OTHER
Identifier Source: secondary_id
2020-005061-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7962-004
Identifier Type: -
Identifier Source: org_study_id
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