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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506334-75 | EudraCT Number |
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This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study
The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seralutinib 90 mg | Experimental | Seralutinib inhaled orally twice per day (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seralutinib | Drug | Capsule containing seralutinib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From baseline to end of study (up to 48 months or availability of commercial product) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in distance achieved on the Six-Minute Walk Test (6MWT) | Δ6MWT from Baseline to End of Study | Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) |
| Changes in NT-proBNP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Aranda, MD | Gossamer Bio Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Advanced Lung Diseases Institute | Fresno | California | 93720 | United States | ||
| Department of Veterans Affairs Greater Los Angeles Healthcare System |
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| Gereic Dry Powder Inhaler |
| Device |
Generic dry powder inhaler for seralutinib delivery |
|
Change in NT-proBNP from Baseline to End of Study |
| Baseline to Week 12, 24, 36, 48, and 60, and then every 16 weeks thereafter + 4 weeks post dose up to end of study (up to 48 months or availability of commercial product) |
| Los Angeles |
| California |
| 90073 |
| United States |
| UC Davis Health Medical Center | Sacramento | California | 95817 | United States |
| Stanford Healthcare | Stanford | California | 94305 | United States |
| University of Florida Health | Gainesville | Florida | 32610 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead | Atlanta | Georgia | 30309 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Northside Hospital - Atlanta | Atlanta | Georgia | 30342 | United States |
| UI Health Hospital | Chicago | Illinois | 60612 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Norton Pulmonary Specialists | Louisville | Kentucky | 40202 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| UNC Hospitals | Chapel Hill | North Carolina | 27514 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| INTEGRIS Cardiovascular Physicians | Oklahoma City | Oklahoma | 73112 | United States |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple Heart and Vascular Institute (Outpatient Clinic) | Philadelphia | Pennsylvania | 19140 | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina - Nexus Research Center | Charleston | South Carolina | 29425 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| Houston Methodist Outpatient Center | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Pulmonary Associates of Richmond, Inc. | Richmond | Virginia | 23230 | United States |
| Cardiologia Palermo | Buenos Aires | Argentina |
| Instituto de Cardiologia de Corrientes Juana Francisca Cabral | Corrientes | Argentina |
| Instuto de Investigacion Clinicas Quilmes | Quilmes | Argentina |
| Instituto Medico Rio Cuarto | Río Cuarto | Argentina |
| Hospital Provincial Dr. Jose Maria Cullen | Santa Fe | Argentina |
| Pulmonary Hypertension Research Queensland | Auchenflower | Australia |
| St Vincent's Hospital (Melbourne) | Fitzroy | Australia |
| Royal Hobart Hospital | Hobart | Australia |
| University Hospitals of Leuven (Campus Gasthuisberg) | Leuven | Belgium |
| Instituto das Pequenas Missionarias de Maria Imaculada - Hospital Madre Teresa | Belo Horizonte | Brazil |
| Complexo de Prevencao, Diagnostico, Terapia e Reabilitacao Respiratoria - Hospital Dia di Pulmao | Blumenau | Brazil |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Brazil |
| Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS | Porto Alegre | Brazil |
| Instituto do Coracao do Hospital das Clinicas da Faculdade de medicina da Universidade de Sao Paulo | São Paulo | Brazil |
| Nucleo de Gestao de Pesquisa/Hospital Sao Paulo - SPDM/UNIFESP | São Paulo | Brazil |
| Peter Lougheed Center | Calgary | Canada |
| London Health Sciences Centre - Victoria Hospital | London | Canada |
| University of Ottawa Heart Institute | Ottawa | Canada |
| University Health Network, Toronto General Hospital | Toronto | Canada |
| Centro de Investigacion Clinica UC-CICUC | Santiago | Chile |
| Enroll SpA | Santiago | Chile |
| Fundacion Abood Shaio | Bogotá | Colombia |
| Fundacion Neumologica Colombiana | Bogotá | Colombia |
| Institut klinicke a experimentalni mediciny Klinika kardiologie Ambulance plicni hypertenze | Prague | Czechia |
| Všeobecná fakultní nemocnice v Praze ll. interní klinika kardiologie a angiologie VFN a 1.LF UK Centrum pro plicní hvpertenzi | Prague | Czechia |
| Aarhus Universiteshospital | Aarhus | Denmark |
| CHU Bicetre, Service de Pneumologie et Reanimation Respiratorie | Le Kremlin-Bicêtre | France |
| Centre Hospitalier REgional Universitaire de Lille Hopital Cardiologique - Institut Coeur Poumon Service de Cardiologie | Lille | France |
| CHU de Nice - Hopital Pasteur | Nice | France |
| CHU de Poitiers | Poitiers | France |
| Zentrum fur Pulmonale Hypertonie, Klinik Ill fur lnnere Medizin (Kardiologie, Pneumologie, lnternistische lntensivmedizin), Herzzentrum der Universitat zu Koln | Cologne | Germany |
| Universitatsklinikum Giessen und Marburg GmbH Zentrum fur lnnere Medizin, Med. Klinik und Poliklinik II Studienambulanz fur Pulmonale Hypertonie | Giessen | Germany |
| Thoraxklinik Heidelberg gGmbH am Universitätsklinikum Heidelberg Zentrum für pulmonale Hypertonie | Heidelberg | Germany |
| Klinikum der LMU Medizinische Klinik und Poliklinik V | Munich | Germany |
| Krankenhaus Neuwittelsbach | München | Germany |
| Klinikum Würzburg Mitte gGmbH Medizinische Klinik mit Schwerpunkt Pneumologie und Beatmungsmedizin | Würzburg | Germany |
| "Evangelismos" General Hospital of Athens, 1st Department of Clinical Care and Pulmonary Hypertension Clinic | Athens | Greece |
| ATTIKON University Hospital, 2nd Critical Care Department | Athens | Greece |
| Onassis Cardiac Surgery Center, Non-Invasive Cardiology Department | Kallithea | Greece |
| AHEPA University General Hospital of Thessaloniki, 1st Cardiology Clinic | Thessaloniki | Greece |
| Mater Misericordiae University Hospital | Dublin | Ireland |
| Lady Davis Carmel Medical Center | Haifa | Israel |
| IRCCS Azienda Ospedaliero Universitaria Di Bologna - Policlinico S. Orsola-Malpighi - UOC Cardiologia | Bologna | Italy |
| Azienda Ospedaliera Dei Colli - Ospedale Monaldi | Naples | Italy |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy |
| A.O.U. Policlinico Umberto I | Roma | Italy |
| University of Tokyo Hospital | Bunkyō City | Japan |
| Kyushu University Hospital | Fukuoka | Japan |
| Kyorin University Hospital | Mitaka | Japan |
| Nagoya University Hospital | Nagoya | Japan |
| NHO Okayama Medical Center | Okayama | Japan |
| Keio University Hospital | Shinjuku-Ku | Japan |
| National Cerebral and Cardiovascular Center | Suita | Japan |
| Pauls Stradins Clinical University Hospital | Riga | Latvia |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos | Kaunas | Lithuania |
| Instituto Nacional de Cardiologia Ignacio Chavez | Mexico City | Mexico |
| Unidad de Investigacion Clinica en Medicina, S.C. | Monterrey | Mexico |
| Amsterdam UMC, location VU mc | Amsterdam | Netherlands |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn z Pododdzialem Intensywnego Nadzoru Kardiologicznego | Krakow | Poland |
| Europejskie Centrum Zdrowia Otwock Sp.zo.o. Szpital im. Fryderyka Chopina Oddzial Kardiologiczny | Otwock | Poland |
| Unidade Local de Saude de Santa Maria, E.P.E. Hospital Pulido Valente | Lisbon | Portugal |
| Unidade Local de Saude de Santo Antonio, E.P.E. Hospital de Santo Antonio | Porto | Portugal |
| Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Cardiology 2 | Bucharest | Romania |
| "Niculae Stancioiu" Emergency Heart Institute for Cardiovascular Diseases, Cardiology 1 Department | Cluj-Napoca | Romania |
| King Fahad Medical City | Riyadh | Saudi Arabia |
| King Faisal Specialist Hospital and Research Center | Riyadh | Saudi Arabia |
| University Clinical Centre of Serbia, Cardiology Clinic | Belgrade | Serbia |
| National Heart Centre Singapore | Singapore | Singapore |
| Asan Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Hospital Clinic I Provincial | Barcelona | Spain |
| Hospital Universitario 12 De Octubre | Madrid | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
| Hospital Universitario de Toledo | Toledo | Spain |
| Royal Papworth Hospital NHS Foundation Trust | Cambridge | United Kingdom |
| Golden Jubilee National Hospital | Clydebank | United Kingdom |
| Hammersmith Hospital | London | United Kingdom |
| Royal Free Hospital, Clinical Research Facility | London | United Kingdom |
| Freeman Hospital | Newcastle | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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