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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7962-031 | Other Identifier | MSD | |
| 2024-518687-12-00 | Registry Identifier | EU CT | |
| U1111-1314-0614 | Registry Identifier | UTN | |
| jRCT2061250021 | Registry Identifier | jRCT (Japan Registry of Clinical Trials) |
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Researchers are looking for other ways to treat pulmonary arterial hypertension (PAH). Sotatercept is a study medicine that is designed to treat PAH.
A past study, MK-7962-024 (LIGHTRAY) (NCT06664801), learned about the safety and effects of sotatercept in people with PAH. One of the goals of that study was to learn about sotatercept when given at a dose (amount) based on the weight range a person is in (weight-banded doses) compared to when given based on a person's exact weight.
This is an extension study, which means people who took part in MK-7962-024 (LIGHTRAY) may be able to join this study. In this extension study, people will get weight-banded doses of sotatercept. The main goal of this study is to learn about the safety of weight-banded doses of sotatercept and if people tolerate it over a longer period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weight-banded sotatercept dosing | Experimental | Participants will receive sotatercept via subcutaneous (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 and will continue treatment for up to 24 months. All eligible participants will receive weight-banded dosing at the dosing level (initial or maintenance) at which they finished MK-7962-024 (LIGHTRAY). Participants will continue to take their background PAH therapy during the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotatercept | Biological | SC injection administered every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. | Up to approximately 28 months |
| Number of Participants who Discontinue Study Intervention Due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported. | Up to approximately 24 months |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular ( Site 1930) | Aurora | Colorado | 80045 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Background PAH Therapy | Drug | 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 |
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| University of Kansas Medical Center ( Site 1928) | Kansas City | Kansas | 66160 | United States |
| University of New Mexico Health Sciences Center - Department of Internal Medicine ( Site 1916) | Albuquerque | New Mexico | 87131 | 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 |
| Instituto de Cardiologia Juana F. Cabral ( Site 0008) | Corrientes | W3400AMZ | Argentina |
| Hospital Provincial Jose Maria Cullen ( Site 0005) | Santa Fe | S3000EOM | 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 |
| IUCPQ ( Site 0208) | Québec | Quebec | G1V 4G5 | Canada |
| Guangdong Provincial People's Hospital-Cardiology ( 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 Colsanitas - Sede Reina Sofia ( Site 0303) | Bogotá | Bogota D.C. | 110111 | Colombia |
| Fundacion Santa Fe de Bogota ( Site 0302) | Bogotá | Bogota D.C. | 110111 | Colombia |
| IMAT S.A.S ( Site 0301) | Montería | Departamento de Córdoba | 230002 | Colombia |
| Clínica Imbanaco S.A.S ( Site 0304) | Cali | Valle del Cauca Department | 760042 | Colombia |
| Vseobecna fakultni nemocnice v Praze ( Site 0400) | Prague | Praha 2 | 128 08 | Czechia |
| CHU Bordeaux Haut-Leveque ( Site 0501) | Pessac | Aquitaine | 33600 | France |
| C.H.U Hôpital Nord ( Site 0500) | Marseille | Bouches-du-Rhone | 13015 | France |
| CHU de Rouen ( Site 0503) | Rouen | Haute-Normandie | 76000 | France |
| CHU GABRIEL MONTPIED ( Site 0504) | Clermont-Ferrand | Puy-de-Dome | 63000 | France |
| Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Családorvosi Intézet és Rendelő ( Site 0704) | Szeged | Csongrád megye | 6725 | Hungary |
| Semmelweis Egyetem ( Site 0701) | Budapest | Pest County | 1083 | Hungary |
| Gottsegen György Országos Kardiovaszkuláris Intézet ( Site 0702) | Budapest | Pest County | 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 |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0902) | Milan | Lombardy | 20122 | Italy |
| Azienda Ospedaliera Universitaria Integrata ( Site 0908) | Verona | Veneto | 37126 | Italy |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0905) | Bologna | 40139 | Italy |
| Ospedale San Martino ( Site 0901) | Genova | 16132 | Italy |
| Fondazione IRCCS Policlinico San Matteo ( Site 0909) | Pavia | 27100 | Italy |
| AOU Policlinico Umberto I ( Site 0910) | Roma | 00161 | 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 |
| 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 ( Site 1304) | Gwangju | Kwangju-Kwangyokshi | 61469 | South Korea |
| Pusan National University Hospital ( Site 1305) | Seogu | 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 Universitario Marqués de Valdecilla ( Site 1405) | Santander | Cantabria | 39008 | Spain |
| Hospital Clinic de Barcelona ( Site 1406) | Barcelona | Catalonia | 08036 | Spain |
| Hospital Universitari Vall d''Hebron ( Site 1404) | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre ( Site 1403) | Madrid | 28041 | Spain |
| Hospital Universitario La Paz ( Site 1410) | Madrid | 28046 | Spain |
| Hospital Universitario Virgen del Rocio ( Site 1407) | Seville | 41013 | Spain |
| HOSPITAL GENERAL UNIVERSITARIO DE TOLEDO ( Site 1408) | Toledo | 45007 | Spain |
| National Cheng Kung University Hospital ( Site 1501) | Tainan | 704302 | Taiwan |
| Taipei Veterans General Hospital ( Site 1502) | Taipei | 112201 | Taiwan |
| Faculty of Medicine Siriraj Hospital ( Site 1600) | Bangkoknoi | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital ( Site 1601) | Muang | Chiang Mai | 50200 | Thailand |
| Royal Papworth Hospital ( Site 1802) | Cambridge | Cambridgeshire | CB2 0AY | United Kingdom |
| Royal Free Hospital ( Site 1803) | London | England | NW3 2QG | United Kingdom |
| Royal Brompton Hospital ( Site 1804) | London | London, City of | SW3 6HP | United Kingdom |
| Hammersmith Hospital ( Site 1801) | London | London, City of | W12 OHS | United Kingdom |
| Golden Jubilee National Hospital ( Site 1800) | Glasgow | Scotland | 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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