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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512278-92-00 | Registry Identifier | EU CT | |
| U1111-1304-7985 | Registry Identifier | UTN | |
| MK-7962-024 | Other Identifier | MSD | |
| jRCT2061240077 | Registry Identifier | jRCT |
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Researchers are looking for other ways to treat people with PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow to the lungs.
The goal of the study is to learn:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-based sotatercept dosing | Experimental | Participants will receive sotatercept via subcutaneous (SC) injection every 3 weeks at an initial dose of 0.3 mg/kg and then at a maintenance dose of 0.7 mg/kg using a weight-based method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study. |
|
| Weight-banded sotatercept dosing | Experimental | Participants will receive sotatercept via SC injection every 3 weeks at an initial dose of up to 45 mg and then at a maintenance dose of up to 90 mg using a weight-banded method during a 24-week treatment period. Participants will continue to take their background PAH therapy during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | SC administered every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Steady-State Average Serum Concentrations of Sotatercept (Cavg) | Steady-state Cavg of sotatercept will be reported. | Predose and at designated time points post-dose (up to 24 weeks) |
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is a health problem that happens or worsens during a study. Number of participants who experience an AE will be reported. | Up to 37 weeks |
| Number of Participants who Discontinue Study Treatment due to an Adverse Event | An AE is a health problem that happens or worsens during a study. Number of participants who discontinue study treatment will be reported. | Up to 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Dose Average Serum Concentrations of Sotatercept (Cavg) | Initial dose Cavg of sotatercept will be reported. | Predose and at designated time points post-dose (up to 3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates, PA ( Site 1903) | Phoenix | Arizona | 85032 | United States | ||
| University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930) |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| Background PAH Therapy | Biological | Background PAH therapy may consist of the following drug classes: single, double, or triple combination of therapy with endothelin-receptor antagonists, phosphodiesterase inhibitors, soluble guanylate cyclase stimulators, and/or prostacyclin analogs or receptor antagonists |
|
| Aurora |
| Colorado |
| 80045 |
| United States |
| Indiana University Health Methodist Hospital ( Site 1905) | Indianapolis | Indiana | 46202 | United States |
| University of Kansas Medical Center ( Site 1928) | Kansas City | Kansas | 66160 | United States |
| Norton Pulmonary Specialists ( Site 1935) | Louisville | Kentucky | 40202 | United States |
| University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916) | Albuquerque | New Mexico | 87131 | United States |
| University of Cincinnati Medical Center ( Site 1927) | Cincinnati | Ohio | 45219 | United States |
| Ascension Seton Heart Specialty Care and Transplant Center ( Site 1918) | Austin | Texas | 78705 | United States |
| Froedtert Hospital & the Medical College of Wisconsin ( Site 1934) | Milwaukee | Wisconsin | 53226 | United States |
| Centro Medico Capital ( Site 0002) | La Plata | Buenos Aires | B1904AAW | Argentina |
| Instituto de Investigaciones Clinicas Mar del Plata ( Site 0006) | Mar del Plata | Buenos Aires | B7600FZO | Argentina |
| Instituto Medico Rio Cuarto ( Site 0010) | Río Cuarto | Córdoba Province | X5800AEV | Argentina |
| Hospital Britanico de Buenos Aires ( Site 0004) | CABA | C1280AEB | Argentina |
| Instituto de Cardiologia Juana F. Cabral ( Site 0008) | Corrientes | W3400AMZ | Argentina |
| Hospital Provincial Jose Maria Cullen ( Site 0005) | Santa Fe | 3000 | Argentina |
| Royal Prince Alfred Hospital ( Site 0103) | Camperdown | New South Wales | 2050 | Australia |
| Westmead Hospital ( Site 0100) | Westmead | New South Wales | 2145 | Australia |
| Wesley Research Institute ( Site 0101) | Auchenflower | Queensland | 4066 | Australia |
| The Alfred Hospital ( Site 0102) | Melbourne | Victoria | 3004 | Australia |
| Peter Lougheed Centre ( Site 0203) | Calgary | Alberta | T1Y 6J4 | Canada |
| IUCPQ ( Site 0208) | Québec | Quebec | G1V 4G5 | Canada |
| Guangdong Provincial People s Hospital ( Site 2000) | Guangzhou | Guangdong | 510080 | China |
| The Second Xiangya Hospital of Central South University ( Site 2002) | Changsha | Hunan | 410011 | China |
| Shanghai Pulmonary Hospital ( Site 2004) | Shanghai | Shanghai Municipality | 200433 | China |
| Yan an Hospital of Kunming City ( Site 2011) | Kunming | Yunnan | 650051 | China |
| Clinica Cardio VID ( Site 0307) | Medellín | Antioquia | 050034 | Colombia |
| Clinica Colsanitas - Sede Reina Sofia ( Site 0303) | Bogotá | Bogota D.C. | 110111 | Colombia |
| Fundacion Santa Fe de Bogota ( Site 0302) | Bogota | Cundinamarca | 110111 | Colombia |
| IMAT S.A.S ( Site 0301) | Montería | Departamento de Córdoba | 230002 | Colombia |
| Centro de Investigaciones Clinicas SAS ( Site 0306) | Cali | Valle del Cauca Department | 760036 | Colombia |
| Clínica Imbanaco S.A.S ( Site 0304) | Cali | Valle del Cauca Department | 760042 | Colombia |
| Centrum pro plicní hypertenzi VFN II. interni klinika VFN a 1. LF UK ( Site 0400) | Prague | Praha 2 | 128 08 | Czechia |
| CHU Bordeaux Haut-Leveque ( Site 0501) | Pessac | Aquitaine | 33604 | France |
| Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0500) | Marseille | Bouches-du-Rhone | 13015 | France |
| CHU Dijon Bourgogne ( Site 0502) | Dijon | Cote-d Or | 21079 | France |
| CHU de Rouen ( Site 0503) | Rouen | Haute-Normandie | 76000 | France |
| CHU GABRIEL MONTPIED ( Site 0504) | Clermont-Ferrand | Puy-de-Dome | 63003 | France |
| Thoraxklinik-Heidelberg gGmbH-Zentrum für Pulmonale Hypertonie ( Site 0600) | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Klinikum der Universität München Großhadern ( Site 0611) | München | Bavaria | 81377 | Germany |
| Medizinische Hochschule Hannover ( Site 0604) | Hanover | Lower Saxony | 30625 | Germany |
| Universitätsklinikum Bonn ( Site 0608) | Bonn | North Rhine-Westphalia | 53127 | Germany |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0609) | Berlin | 10117 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf ( Site 0610) | Hamburg | 20246 | Germany |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 0704) | Szeged | Csongrád megye | 6725 | Hungary |
| Pécsi Tudományegyetem Klinikai Központ ( Site 0703) | Pécs | Pecs | 7624 | Hungary |
| Semmelweis Egyetem ( Site 0701) | Budapest | Pest County | 1083 | Hungary |
| Gottsegen Gyorgy Orszagos Kardiologiai Intezet ( Site 0702) | Budapest | 1096 | Hungary |
| Rambam Health Care Campus ( Site 0802) | Haifa | 3109601 | Israel |
| Carmel Hospital ( Site 0803) | Haifa | 3436212 | Israel |
| Rabin Medical Center ( Site 0805) | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center ( Site 0801) | Ramat Gan | 5265601 | Israel |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905) | Bologna | Emilia-Romagna | 40138 | Italy |
| AOU Policlinico Umberto I ( Site 0910) | Rome | Lazio | 00161 | Italy |
| Ospedale San Martino ( Site 0901) | Genoa | Liguria | 16132 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda ( Site 0900) | Milan | Lombardy | 20162 | Italy |
| Fondazione IRCCS San Gerardo dei Tintori ( Site 0911) | Monza | Lombardy | 20900 | Italy |
| A.O.U. Citta della Salute e della Scienza di Torino ( Site 0904) | Turin | Piedmont | 10126 | Italy |
| Azienda Ospedaliera Universitaria Integrata ( Site 0908) | Verona | Veneto | 37126 | Italy |
| Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0902) | Milan | 20122 | Italy |
| Fondazione IRCCS Policlinico San Matteo ( Site 0909) | Pavia | 27100 | Italy |
| Fondazione G. Monasterio ( Site 0907) | Pisa | 56124 | Italy |
| Ospedale Civile SS Annunziata ( Site 0903) | Sassari | 07100 | Italy |
| Nagoya University Hospital ( Site 2102) | Nagoya | Aichi-ken | 466-8560 | Japan |
| National Cerebral and Cardiovascular Center ( Site 2103) | Suita | Osaka | 564-8565 | Japan |
| The University of Tokyo Hospital ( Site 2101) | Bunkyo | Tokyo | 113-8655 | Japan |
| Kyorin University Hospital ( Site 2100) | Mitaka | Tokyo | 181-8611 | Japan |
| Kyushu University Hospital ( Site 2105) | Fukuoka | 812-8582 | Japan |
| National Hospital Organization Okayama Medical Center ( Site 2104) | Okayama | 701-1192 | Japan |
| Radboud University Medical Center ( Site 1001) | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Sint Antonius Ziekenhuis ( Site 1000) | Nieuwegein | Utrecht | 3435CM | Netherlands |
| Krakowski Szpital Specjalistyczny im. św. Jana Pawła II ( Site 1100) | Krakow | Lesser Poland Voivodeship | 31-202 | Poland |
| National University Heart Centre, Singapore ( Site 1200) | Singapore | Central Singapore | 119074 | Singapore |
| National Heart Centre Singapore ( Site 1201) | Singapore | Central Singapore | 169609 | Singapore |
| Chonnam National University Hospital (CNUH) ( Site 1304) | Gwangju | Kwangju-Kwangyokshi | 61469 | South Korea |
| Pusan National University Hospital ( Site 1305) | Busan | Pusan-Kwangyokshi | 49241 | South Korea |
| Seoul National University Hospital ( Site 1302) | Seoul | 03080 | South Korea |
| Severance Hospital Yonsei University Health System ( Site 1300) | Seoul | 03722 | South Korea |
| Asan Medical Center ( Site 1303) | Seoul | 05505 | South Korea |
| Samsung Medical Center ( Site 1301) | Seoul | 06351 | South Korea |
| Hospital Universitari Son Espases ( Site 1412) | Palma | Balearic Islands | 07120 | Spain |
| Hospital Marques de Valdecilla ( Site 1405) | Santander | Cantabria | 39008 | Spain |
| Hospital Clinic de Barcelona ( Site 1406) | Barcelona | Catalonia | 08036 | Spain |
| Hospital Vall D Hebron ( Site 1404) | Barcelona | 08035 | Spain |
| Hospital Ramon y Cajal ( Site 1401) | Madrid | 28034 | Spain |
| Hospital General Universitario 12 de Octubre ( Site 1403) | Madrid | 28041 | Spain |
| Hospital Universitario La Paz ( Site 1410) | Madrid | 28046 | Spain |
| Hospital Virgen del Rocio ( Site 1407) | Seville | 41013 | Spain |
| Hospital Universitario de Toledo ( Site 1408) | Toledo | 45007 | Spain |
| Kaohsiung Veterans General Hospital ( Site 1503) | Kaohsiung City | 813414 | Taiwan |
| National Cheng Kung University Hospital ( Site 1501) | Tainan | 70403 | Taiwan |
| Taipei Veterans General Hospital ( Site 1502) | Taipei | 11217 | Taiwan |
| Faculty of Medicine Siriraj Hospital ( Site 1600) | Bangkok | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital ( Site 1601) | Chiang Mai | 50200 | Thailand |
| Royal Papworth Hospital ( Site 1802) | Cambridge | Cambridgeshire | CB2 0AY | United Kingdom |
| Royal Free London NHS Foundation Trust ( Site 1803) | London | London, City of | NW3 2QG | United Kingdom |
| Royal Brompton Hospital ( Site 1804) | London | London, City of | SW3 6NP | United Kingdom |
| Hammersmith Hospital ( Site 1801) | London | London, City of | W12 OHS | United Kingdom |
| Golden Jubilee National Hospital ( Site 1800) | Glasgow | West Dunbartonshire | G81 4DY | United Kingdom |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C542017 | ACE-011 |
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