Sikkerhed og effekt af Selonsertib hos voksne med ikke-alkoholisk Steatohepatitis (NASH) og brodannende (F3) fibrose (STELLAR-3)
10. juni 2020 opdateret af: Gilead Sciences
En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse, der evaluerer sikkerheden og effektiviteten af Selonsertib hos personer med ikke-alkoholisk Steatohepatitis (NASH) og brodannende (F3) fibrose
Det primære formål med denne undersøgelse er at evaluere, om selonsertib (SEL; GS-4997) kan forårsage fibrose-regression og reducere progression til cirrhose og associerede komplikationer hos voksne med NASH og brodannende (F3) fibrose.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
808
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina, 450
- Hospital Italiano de Buenos Aires
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Córdoba, Argentina, X5000JJS
- Instituto Oulton
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New South Wales
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Darlinghurst, New South Wales, Australien, 2010
- St. Vincent's Hospital Sydney
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Kogarah, New South Wales, Australien, 2217
- St. George's Hospital
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Westmead, New South Wales, Australien, 2145
- Westmead Hospital
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Queensland
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Herston, Queensland, Australien, 4029
- Royal Brisbane & Women's Hospital
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South Australia
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Adelaide, South Australia, Australien, 5000
- Royal Adelaide Hospital
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Victoria
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Clayton, Victoria, Australien, 3168
- Monash Health, Monash Medical Centre
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Fitzroy, Victoria, Australien, 3065
- St. Vincent's Hospital Melbourne
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Heidelberg, Victoria, Australien, 3084
- Austin Hospital
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Melbourne, Victoria, Australien, 3004
- The Alfred Hospital, Alfred Health
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Western Australia
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Perth, Western Australia, Australien, 6000
- Royal Perth Hospital
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Brussel, Belgien, 1090
- UZ Brussel
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Brussels, Belgien, 1070
- CUB Hôpital Erasme
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Leuven, Belgien, 3000
- Universitaire Ziekenhuizen Leuven
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Botucatu, Brasilien, 18618-000
- Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
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Porto Alegre, Brasilien, CEP 90035-903
- Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
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Ribeirão Preto, Brasilien, 14048-900
- Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
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São Paulo, Brasilien, 01246-903
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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São Paulo, Brasilien, 04040-003
- Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- University of Calgary Liver Unit (Heritage Medical Research Clinic)
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Edmonton, Alberta, Canada, T6G 2X8
- University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Gordon and Leslie Diamond Health Care Centre
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Vancouver, British Columbia, Canada, V6Z 2K5
- (G.I.R.I.) GI Research Institute
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Vancouver, British Columbia, Canada, V5Z 1H2
- Lair Centre
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Victoria, British Columbia, Canada, V8T 5G4
- PerCuro Clinical Research Ltd.
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Nova Scotia
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Bridgewater, Nova Scotia, Canada, B4V 3N2
- South Shore Medical Arts
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Ontario
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Brampton, Ontario, Canada
- William Osler Health System-Brampton Civic Hospital
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London, Ontario, Canada, N6A 5A5
- South Shore Medical Arts
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Toronto, Ontario, Canada, M5G 2C4
- Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
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Quebec
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Montréal, Quebec, Canada, H4A 3JI
- Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
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Cambridge, Det Forenede Kongerige, CB2 0QQ
- Cambridge University Hospitals NHS Foundation Trust
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Derby, Det Forenede Kongerige, DE22 3NE
- Derby Teaching Hospitals NHS FT
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Edgbaston, Det Forenede Kongerige, B15 2TH
- University Hospitals Birmingham NHS Foundation Trust
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London, Det Forenede Kongerige, SE5 9RS
- King's College Hospital NHS Foundation Trust
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London, Det Forenede Kongerige, W21NY
- Imperial College Healthcare NHS Trust
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Newcastle upon Tyne, Det Forenede Kongerige, NE2 3HH
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
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Norwich, Det Forenede Kongerige, NR4 7UY
- Norfolk and Norwich University Hospitals Nhs Foundation Trust
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Nottingham, Det Forenede Kongerige, NG7 2UH
- Nottingham University Hospitals Nhs Trust
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Portsmouth, Det Forenede Kongerige, PO6 3LY
- Portsmouth Hospitals NHS Trust
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Swansea, Det Forenede Kongerige, SA2 8QA
- Abertawe Bro Morgannwg University Health Board
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Arizona
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Chandler, Arizona, Forenede Stater, 85224
- Institute of Liver Health
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Phoenix, Arizona, Forenede Stater, 85013
- St. Joseph's Hospital and Medical Center
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Phoenix, Arizona, Forenede Stater, 85054
- Mayo Clinic
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Phoenix, Arizona, Forenede Stater, 85006
- Banner University Medical Center-Phoenix
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Tucson, Arizona, Forenede Stater, 85724
- University of Arizona
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72204
- Baptist Medical Center
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North Little Rock, Arkansas, Forenede Stater, 72204
- Arkansas Gastroenterology
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California
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Chula Vista, California, Forenede Stater, 91911
- eStudySite
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Coronado, California, Forenede Stater, 92673
- Southern California Liver Centers
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Costa Mesa, California, Forenede Stater, 92626
- United Gastroenterologists
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El Cajon, California, Forenede Stater, 92020
- TriWest Research Associates, LLC
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Fresno, California, Forenede Stater, 93720
- Fresno Clinical Research Center
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La Jolla, California, Forenede Stater, 92103
- University of California San Diego (UCSD)
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Los Angeles, California, Forenede Stater, 90048
- Cedars Sinai Medical Center
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Los Angeles, California, Forenede Stater, 90073
- VA Greater Los Angeles Healthcare System
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Los Angeles, California, Forenede Stater, 90036
- Ruane Clinical Research Group
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Oceanside, California, Forenede Stater, 92056
- eStudySite
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Pasadena, California, Forenede Stater, 91105
- California Liver Institute
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Rialto, California, Forenede Stater, 92377
- Inland Empire Liver Foundation
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Sacramento, California, Forenede Stater, 95817
- University of California, Davis Medical Center
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San Diego, California, Forenede Stater, 92123
- Medical Associates Research Group
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San Diego, California, Forenede Stater, 92514
- Kaiser Permanente
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San Francisco, California, Forenede Stater, 94143
- University of California San Francisco (UCSF)
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San Francisco, California, Forenede Stater, 94115
- California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
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San Francisco, California, Forenede Stater, 94115
- Mission Gastroenterology and Hepatology
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San Jose, California, Forenede Stater, 95128
- Silicon Valley Research Institute
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University School of Medicine
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Florida
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Doral, Florida, Forenede Stater, 33166
- Integrity Clinical Research, LLC
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Gainesville, Florida, Forenede Stater, 32610
- UF Hepatology Research at CTRB
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Jacksonville, Florida, Forenede Stater, 32207
- UF Health Jacksonville-Gastroenterology Emerson
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Lakewood Ranch, Florida, Forenede Stater, 34211
- Florida Research Institute
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Lauderdale Lakes, Florida, Forenede Stater, 33319
- Sunrise Medical Research, Inc
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Miami, Florida, Forenede Stater, 33136
- Schiff Center for Liver Diseases/University of Miami
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Miami, Florida, Forenede Stater, 33165
- Genoma Research Group, Inc
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Miami, Florida, Forenede Stater, 33130
- Sunrise Research Institute
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New Port Richey, Florida, Forenede Stater, 34653
- Advanced Research Institute
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Orange City, Florida, Forenede Stater, 32763
- Avail Clinical Research, LLC
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Wellington, Florida, Forenede Stater, 33414
- South Florida Center of Gastroenterology, PA
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Zephyrhills, Florida, Forenede Stater, 33540
- Florida Medical Clinic, PA
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Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Digestive Healthcare of Georgia
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Atlanta, Georgia, Forenede Stater, 30309
- Piedmont Transplant Institute
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Marietta, Georgia, Forenede Stater, 30060
- Gastrointestinal Specialists of Georgia, PC
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern Memorial Hospital; Clinical Research Unit
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Chicago, Illinois, Forenede Stater, 60615
- The University of Chicago Medical Center
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Glenview, Illinois, Forenede Stater, 60026
- NorthShore University Healthsystem
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46237
- Indianapolis Gastroenterology Research Foundation
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Health - University Hospital
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center
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Kentucky
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Hazard, Kentucky, Forenede Stater, 41707
- Gastroenterology Associates Of Hazard
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Louisiana
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Bastrop, Louisiana, Forenede Stater, 71021
- Delta Research Partners, LLC
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New Orleans, Louisiana, Forenede Stater, 70112
- Tulane University Health Sciences Center
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New Orleans, Louisiana, Forenede Stater, 70121
- Ocshner Medical Center
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Shreveport, Louisiana, Forenede Stater, 71105
- Louisiana Research Center, LLC
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Maryland
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Baltimore, Maryland, Forenede Stater, 21202
- Mercy Medical Center
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Bethesda, Maryland, Forenede Stater, 20889
- Walter Reed National Military Medical Center
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Catonsville, Maryland, Forenede Stater, 21228
- Digestive Disease Associates, PA
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Hagerstown, Maryland, Forenede Stater, 21472
- Meritus Center for Clinical Research
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Health System
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Wyoming, Michigan, Forenede Stater, 49519
- Gastroenterology Associates of Western Michigan, P.L.C.
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Ypsilanti, Michigan, Forenede Stater, 48197
- Huron Gastroenterology Associates/Center for Digestive Care
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- University of Minnesota Medical Center - Fairview
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Rochester, Minnesota, Forenede Stater, 55095
- Mayo Clinic
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Mississippi
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Ridgeland, Mississippi, Forenede Stater, 39157
- Southern Therapy and Advanced Research LLC (STAR)
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Missouri
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Kansas City, Missouri, Forenede Stater, 64111
- Saint Luke's Hospital of Kansas City
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Kansas City, Missouri, Forenede Stater, 64131
- Kansas City Gastroenterology and Hepatology
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Saint Louis, Missouri, Forenede Stater, 63104
- Saint Louis University
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- eStudySite
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New Jersey
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Newark, New Jersey, Forenede Stater, 07102
- Rutgers New Jersey Medical School- Doctors Office Center
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New York
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Buffalo, New York, Forenede Stater, 14230
- University of Buffalo, Clinical and Translational Research Center
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Manhasset, New York, Forenede Stater, 11030
- Northwell Health - Sandra Atlas Bass Center for Liver Diseases
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New York, New York, Forenede Stater, 10003
- Icahn School of Medicine at Mount Sinai Beth Israel
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina at Chapel Hill / UNC School of Medicine
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center - Duke South Clinics
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Fayetteville, North Carolina, Forenede Stater, 28304
- Cumberland Research Associates, LLC
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Greensboro, North Carolina, Forenede Stater, 27410
- Triad Clinical Trials LLC
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Huntersville, North Carolina, Forenede Stater, 28078
- Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
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Rocky Mount, North Carolina, Forenede Stater, 27804
- PMG Research of Rocky Mount, LLC
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Statesville, North Carolina, Forenede Stater, 28625
- Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Digestive Health Specialists, PA
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45249
- Consultants for Clinical Research
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Cincinnati, Ohio, Forenede Stater, 45267
- UC Health/Holmes Hospital
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Pennsylvania
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Bethlehem, Pennsylvania, Forenede Stater, 18017
- Northeast Clinical Research Center, LLC
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, Forenede Stater, 15240
- VA Pittsburgh Healthcare System
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
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Pittsburgh, Pennsylvania, Forenede Stater, 15251
- eStudySite
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Sayre, Pennsylvania, Forenede Stater, 18840
- Guthrie Medical Group, PC
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02905
- University Gastroenterology
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29245
- Medical University of South Carolina
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Greenville, South Carolina, Forenede Stater, 29605
- Greenville Health System - Gastroenterology and Liver Center
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37421
- WR-ClinSearch, LLC
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Germantown, Tennessee, Forenede Stater, 38138
- Gastro One
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Nashville, Tennessee, Forenede Stater, 37211
- Quality Medical Research PLLC
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Nashville, Tennessee, Forenede Stater, 37212
- Vanderbilt University Medical Center - Digestive Disease Center
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Texas
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Arlington, Texas, Forenede Stater, 76012
- Texas Clinical Research Institute, LLC
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Austin, Texas, Forenede Stater, 78756
- Austin Center for Clinical Research
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Austin, Texas, Forenede Stater, 78746
- Pinnacle Clinical Research, PLLC
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Dallas, Texas, Forenede Stater, 75203
- The Liver Institute at Methodist Dallas Medical Center
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Dallas, Texas, Forenede Stater, 75246
- Texas Digestive Disease Consultants
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Fort Worth, Texas, Forenede Stater, 76104
- Baylor Scott & White All Saints Medical Center
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Houston, Texas, Forenede Stater, 77025
- Kelsey-Seybold Clinic
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Houston, Texas, Forenede Stater, 77030
- Baylor College of Medicine - Advanced Liver Therapies
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Houston, Texas, Forenede Stater, 77030
- VAMC & Baylor College
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Live Oak, Texas, Forenede Stater, 78233
- Pinnacle Clinical Research, PLLC
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San Antonio, Texas, Forenede Stater, 78215
- American Research Corporation, The Texas Liver Institute
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Utah
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Murray, Utah, Forenede Stater, 84107
- Intermountain Liver Disease and Transplant Center
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Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah Hospital
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Vermont
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Burlington, Vermont, Forenede Stater, 05401
- The University of Vermont Medical Center
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia Medical Center
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Fairfax, Virginia, Forenede Stater, 22031
- Verity Research, Inc.
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Falls Church, Virginia, Forenede Stater, 22042
- Inova Fairfax Medical Campus
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Lansdowne Town Center, Virginia, Forenede Stater, 20716
- Emeritas Research Group
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Newport News, Virginia, Forenede Stater, 23602
- Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
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Norfolk, Virginia, Forenede Stater, 23502
- Digestive and Liver Disease Specialists
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Richmond, Virginia, Forenede Stater, 23298
- Virginia Commonwealth University
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Richmond, Virginia, Forenede Stater, 23249
- McGuire VA Medical Center
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Richmond, Virginia, Forenede Stater, 23226
- Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
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Washington
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Seattle, Washington, Forenede Stater, 98101
- Virginia Mason
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Seattle, Washington, Forenede Stater, 98104
- Swedish Organ Transplant and Liver Center
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Froedtert Memorial Lutheran Hospital
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Angers, Frankrig, 49033
- Centre Hospitalier Universitaire D'Angers
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Clermont-Ferrand, Frankrig, 63003
- Centre Hospitalier Universitaire Estaing
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Créteil, Frankrig, 94010
- Hôpital Henri Mondor
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Grenoble, Frankrig, 38043
- CHU de Grenoble- Hopital Michallon
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Lille, Frankrig, 59000
- Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
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Limoges, Frankrig, 87000
- CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
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Lyon, Frankrig, 69317
- Hôpital de la Croix Rousse
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Marseille, Frankrig, 13008
- Hopital Saint Joseph
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Nice, Frankrig, 06200
- Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
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Paris, Frankrig, 75014
- Hôpital Cochin
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Pessac, Frankrig, 33604
- Centre hospitalier universitaire de Bordeaux
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Pessac, Frankrig, 33600
- Hôpital Beaujon
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Strasbourg, Frankrig, 67091
- Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
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Toulouse, Frankrig, 31059
- Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
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Villejuif, Frankrig, 94800
- Hôpital Paul Brousse
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-
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Utrecht, Holland, 3508 GA
- University Medical Center Utrecht
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-
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Tai Po, Hong Kong
- Alice Ho Miu Ling Nethersole Hospital
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Tuen Mun, Hong Kong
- Tuen Mun Hospital
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-
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Kolkata, Indien, 700020
- Institute of Post Graduate Medical Education and Research / SSKM Hospital
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Mangalore, Indien, 575001
- Kasturba Medical College (KMC) Hospital
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Mumbai, Indien, 400012
- Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)
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New Delhi, Indien, 110029
- All India Institute of Medical Sciences
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New Delhi, Indien, 110026
- Maharaja Agrasen Hospital
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New Delhi, Indien, 110070
- Fortis Flt. Lt. Rajan Dhall Hospital
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New Delhi, Indien, 110070
- Institute of Liver & Biliary Sciences
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Maharashtra
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Nagpur, Maharashtra, Indien, 440010
- Midas Multispecialty Hospital
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-
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-
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Haifa, Israel, 3436212
- The Lady Davis Carmel Medical Center
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Haifa, Israel, 30196
- Rambam Health Care Campus
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Nazaret, Israel, 91008
- Holy Family Hospital
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Ramat Gan, Israel, 52621
- The Chaim Sheba Medical Center
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Tel Aviv, Israel, 64239
- Tel-Aviv Sourasky Medical Center
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-
-
-
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Milan, Italien, 20122
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
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Pisa, Italien, 56124
- Azienda Ospedaliera Universitaria Pisana
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San Giovanni Rotondo, Italien, 71013
- IRCCS Ospedale Casa Sollievo Della Soferrenza
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-
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-
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Chiba, Japan, 260-8670
- Chiba University Hospital
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Fukui-shi, Japan, 918-8503
- Fukui-ken Saiseikai Hospital
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Hiroshima, Japan, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Ibaraki, Japan, 300-0395
- Tokyo Medical University Ibaraki Medical Center
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Izunokuni, Japan, 410-2295
- Juntendo University Shizuoka Hospital
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Kagoshima, Japan, 890-8520
- Kagoshima University Medical and Dental Hospital
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Kanagawa, Japan, 920-8641
- Kanazawa University Hospital
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Kashihara, Japan, 634-8522
- Nara Medical University Hospital
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Kawasaki, Japan, 105-8470
- Toranomon Hospital Kajigaya
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Kitakyushu, Japan, 803-8505
- Shinkokura Hospital
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Kumamoto, Japan, 862-8655
- Kumamoto Shinto General Hospital
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Kurume, Japan, 830-0011
- Kurume University Hospital
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Kyoto, Japan, 602-8566
- University Hospital, Kyoto Prefectural University of Medicine
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Matsumoto, Japan, 390-8621
- Shinshu University Hospital
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Minato, Japan, 105-8470
- Toranomon Hospital
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Miyazaki, Japan, 880-0003
- Miyazaki Medical Center Hospital
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Musashino, Japan, 180-8610
- Japanese Red Cross Musashino Hospital
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Nagakute, Japan, 480-1195
- Aichi Medical University Hospital
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Nakagami, Japan, 901-2492
- Heart Life Hospital
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Nara, Japan, 630-8305
- Nara City Hospital
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Nishinomiya, Japan, 663-8501
- Hyogo College of Medicine Hospital
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Okayama, Japan, 700-808
- Kawasaki Medical School General Medical Center
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Osaka, Japan, 540-0006
- National Hospital Organization Osaka National Hospital
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Saga, Japan, 849-8501
- Saga University Hospital
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Sapporo, Japan, 600-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
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Sendai, Japan, 981-8563
- Tohoku Rosai Hospital
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Shinjuku-ku, Japan, 162-8655
- National Center for Global Health and Medicine Hospital
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Suita, Japan, 564-0013
- Saiseikai Suita Hospital
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Takamatsu, Japan, 760-8557
- Kagawa Prefectural Central Hospital
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Tsu, Japan, 514-8507
- Mie University Hospital
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Tōno, Japan, 7190295
- Ehime University Hospital
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Yamagata, Japan, 990-9585
- Yamagata University Hospital
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Yokohama, Japan, 236-0004
- Yokohama City University Hospital
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Ōmura, Japan, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Ōsaka, Japan, 573-0153
- Hirakata kohsai Hospital
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-
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Daegu, Korea, Republikken, 700-721
- Kyungpook National University Hospital
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Daegu, Korea, Republikken, 41931
- Keimyung University Dongsan Medical Center
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Goyang-si, Korea, Republikken, 10444
- National Health Insurance Service- Ilsan Hospital
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Seoul, Korea, Republikken, 135-720
- Gangnam Severance Hospital
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Seoul, Korea, Republikken, 152-703
- Korea University Guro Hospital
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Seoul, Korea, Republikken, 05505
- Asan Medical Center
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Seoul, Korea, Republikken, 06973
- Chung-Ang University Hospital
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Seoul, Korea, Republikken, 04763
- Hanyang University Seoul Hospital
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Seoul, Korea, Republikken, 120-752
- Severance Hospital, Yonsei University Health System
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Seoul, Korea, Republikken, 37061
- SMG-SNU Boramae Medical Center
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Wŏnju, Korea, Republikken, 26426
- Yonsei University Wonju Severance Christian Hospital
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Batu Caves, Malaysia, 68100
- Hospital Selayang
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Kuala Lumpur, Malaysia, 50603
- University of Malaya Medical Centre
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Cuautitlán, Mexico, 54769
- Phylasis Clinicas Research S. de RL de CV.
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Mexico City, Mexico, 6700
- Consultorio Medico
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Monterrey, Mexico, 64000
- Investigaciones Medicas Cisneros SC
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Grafton, New Zealand, 1023
- Auckland City Hospital
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Bytom, Polen, 41-902
- Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
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Łódź, Polen, 91-347
- Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
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Vila Real, Portugal, 5000
- Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E
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-
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San Juan, Puerto Rico, 00927
- Fundacion De Investigacion de Diego
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San Juan, Puerto Rico, 00921
- VA Caribbean Healthcare System
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San Juan, Puerto Rico, 00907
- Klinical Investigations Group, LLC
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-
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Bern, Schweiz, 3010
- Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
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Lugano, Schweiz, 6900
- Istituto Cantonale di Patologia Locarno
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Singapore, Singapore, 529889
- Changi General Hospital Pte Ltd.
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Singapore, Singapore, 119074
- National University Hospital
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Singapore, Singapore, 308433
- Tan Tock Seng Hospital
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Singapore, Singapore, 169856
- Singapore General Hospital
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Singapore, Singapore, 768828
- Khoo Teck Puat Hospital
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Barcelona, Spanien, 08003
- Hospital del Mar
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Barcelona, Spanien, 08036
- Hospital Clinic de Barcelona
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Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron
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Madrid, Spanien, 28046
- Hospital Universitario La Paz
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Majadahonda, Spanien, 28220
- Hospital Puerto de Hierro Majadahonda
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Pontevedra, Spanien, 36071
- CHOP_Complejo Hospitalrio Universitario de Pontevedra
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Santander, Spanien, 39008
- Hospital Universitario Marques de Valdecilla
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Sevilla, Spanien, 41013
- Hospital Universitario Virgen Del Rocio
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Valencia, Spanien, 46026
- Hospital Universitari i Politecnic La Fe de Valencia
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Chang-hua, Taiwan, 500
- Changhua Christian Hospital
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Chiayi City, Taiwan, 60002
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
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Kaohsiung, Taiwan, 82445
- E-Da Hospital
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Kaohsiung, Taiwan, 80099
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Keelung, Taiwan, 20401
- Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Tainan, Taiwan, 7428
- National Cheng Kung University Hospitalv
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 10630
- Cathay General Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10449
- Mackay Memorial Hospital
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Taoyuan, Taiwan, 33305
- Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
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Aachen, Tyskland, 52074
- Uniklinik RWTH Aachen, Medizinische Klinik III
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Berlin, Tyskland, 13353
- Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
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Bonn, Tyskland, 53105
- Universitätsklinikum Bonn (AöR)
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Frankfurt, Tyskland, 60590
- Universitatsklinikum Frankfurt der Goethe-Universitat
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Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
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Homburg, Tyskland, 66421
- Uniklinikum des Saarlandes- Klinik fur Innere Medizin II
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Kiel, Tyskland, 24146
- Gastroenterologisch- Hepatologisches Zentrum Kiel
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Leipzig, Tyskland, 04103
- Eugastro Gmbh
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Mainz, Tyskland, 55131
- Johannes Gutenberg-Universität
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Graz, Østrig, A-8036
- Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
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Vienna, Østrig, 1090
- Allgemeines Krankenhaus Wien
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (VOKSEN, OLDER_ADULT)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Nøgleinklusionskriterier:
- Leverbiopsi i overensstemmelse med NASH og brodannelse (F3 fibrose) i henhold til NASH Clinical Research Network (CRN) klassifikationen efter den centrale læsers mening
Har følgende laboratorieparametre ved screeningsbesøget:
- Alaninaminotransferase (ALT) ≤ 8 x øvre normalgrænse (ULN)
- Kreatininclearance (CLcr) ≥ 30 milliliter/minut (mL/min), som beregnet ved Cockcroft-Gault-ligningen
- Hæmoglobin A1c (HbA1c) ≤ 9,5 % (eller serumfructosamin ≤ 381 μmol, hvis HbA1c ikke kan opnås)
- Total bilirubin ≤ 1,3 x ULN (medmindre en alternativ ætiologi såsom Gilberts syndrom eller hæmolytisk anæmi er til stede)
Nøgleekskluderingskriterier:
- Tidligere anamnese med dekompenseret leversygdom inklusive klinisk ascites, hepatisk encefalopati (HE) eller varicealblødning
- Child-Pugh (CP) score > 6, som bestemt ved screening, medmindre det skyldes terapeutisk anti-koagulation
- Model for End-stage Lever Disease (MELD) score > 12, som bestemt ved screening, medmindre det skyldes terapeutisk anti-koagulation
- Andre årsager til leversygdom, herunder, men ikke begrænset til, alkoholisk leversygdom, hepatitis B, hepatitis C, autoimmune lidelser, lægemiddelinduceret hepatotoksicitet, Wilsons sygdom, jernoverbelastning og alfa-1-antitryspin-mangel, baseret på sygehistorie og/ eller centraliseret gennemgang af leverhistologi.
- Historie om levertransplantation
- Nuværende eller historie med hepatocellulært karcinom (HCC)
Bemærk: Andre protokoldefinerede inklusions-/eksklusionskriterier kan være gældende.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: DOBBELT
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
EKSPERIMENTEL: SEL 18 mg
Randomiseret fase: Selonsertib (SEL) 18 mg tablet + placebo for at matche SEL 6 mg tablet i 240 uger Open-Label (OL) fase: Deltagere, der oplever en leverklinisk hændelse eller har biopsi bekræftet progression til skrumpelever i den randomiserede fase, før de afslutter uge 240-besøget, vil blive tilbudt muligheden for at rulle over i en OL-fase for at modtage OL SEL 18 mg for en samlet behandlingsvarighed på 240 uger inklusive den randomiserede fase. |
Tabletter indgivet oralt én gang dagligt
Andre navne:
Tabletter indgivet oralt én gang dagligt
|
|
EKSPERIMENTEL: SEL 6 mg
Randomiseret fase: SEL 6 mg tablet + placebo for at matche SEL 18 mg tablet i 240 uger OL-fase: Deltagere, der oplever en hepatisk klinisk hændelse eller har biopsi bekræftet progression til skrumpelever i den randomiserede fase, inden de afslutter uge 240-besøget, vil blive tilbudt muligheden for at rulle over i en OL-fase for at modtage OL SEL 18 mg for en samlet behandlingsvarighed på 240 uger inklusive den randomiserede fase. |
Tabletter indgivet oralt én gang dagligt
Andre navne:
Tabletter indgivet oralt én gang dagligt
|
|
PLACEBO_COMPARATOR: Placebo
Randomiseret fase: Placebo for at matche SEL 6 mg tablet + placebo for at matche SEL 18 mg tablet i 240 uger OL-fase: Deltagere, der oplever en hepatisk klinisk hændelse eller har biopsi bekræftet progression til skrumpelever i den randomiserede fase, inden de afslutter uge 240-besøget, vil blive tilbudt muligheden for at rulle over i en OL-fase for at modtage OL SEL 18 mg for en samlet behandlingsvarighed på 240 uger inklusive den randomiserede fase. |
Tabletter indgivet oralt én gang dagligt
Tabletter indgivet oralt én gang dagligt
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere, der opnåede en ≥ 1-trins forbedring i fibrose i henhold til klassificeringen af Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) uden forværring af NASH i uge 48
Tidsramme: Uge 48
|
Fibroseforbedring blev defineret som ≥ 1-trins fald fra baseline i fibrose i henhold til NASH CRN-klassifikationen.
NASH CRN-fibrosestadier varierer fra 0 til 4, med højere score, der indikerer større fibrose (0=Ingen, 4=Cirrhose).
Forværring af NASH blev defineret som ≥ 1 point stigning fra baseline i hepatocellulær ballondannelse eller lobulær inflammation i henhold til kriterierne for ikke-alkoholisk fedtleversygdom (NAFLD) Activity Score (NAS).
Som defineret af NAS varierer hepatocellulær ballondannelse fra 0-2, og lobulær inflammation varierer fra 0-3, med højere score, der indikerer mere alvorlig hepatocellulær ballondannelse eller lobulær inflammation.
|
Uge 48
|
|
Hændelsesfri overlevelse (EFS) i uge 240 som vurderet efter tid til første kliniske hændelse
Tidsramme: Uge 240
|
EFS blev vurderet ved tiden til den første kliniske hændelse, inklusive progression til cirrhose på leverbiopsi, leverdekompensation, levertransplantation og dødelighed af alle årsager.
|
Uge 240
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere, der havde en ≥ 1-trins forbedring i fibrose uden forværring af NASH i uge 240
Tidsramme: Uge 240
|
Fibroseforbedring blev defineret som ≥ 1-trins fald fra baseline i fibrose i henhold til NASH CRN-klassifikationen.
NASH CRN-fibrosestadier varierer fra 0 til 4, med højere score, der indikerer større fibrose (0=Ingen, 4=Cirrhose).
Forværring af NASH blev defineret som ≥ 1 point stigning fra baseline i hepatocellulær ballondannelse eller lobulær inflammation i henhold til NAS-kriterierne.
Som defineret af NAS varierer hepatocellulær ballondannelse fra 0-2, og lobulær inflammation varierer fra 0-3, med højere score, der indikerer mere alvorlig hepatocellulær ballondannelse eller lobulær inflammation.
|
Uge 240
|
|
Procentdel af deltagere, der havde en ≥ 1-trins forbedring i fibrose i uge 48
Tidsramme: Uge 48
|
Fibroseforbedring blev defineret som ≥ 1-trins fald fra baseline i fibrose i henhold til NASH CRN-klassifikationen.
NASH CRN-fibrosestadier varierer fra 0 til 4, med højere score, der indikerer større fibrose (0=Ingen, 4=Cirrhose).
|
Uge 48
|
|
Procentdel af deltagere, der havde en ≥ 1-trins forbedring i fibrose i uge 240
Tidsramme: Uge 240
|
Fibroseforbedring blev defineret som ≥ 1-trins fald fra baseline i fibrose i henhold til NASH CRN-klassifikationen.
NASH CRN-fibrosestadier varierer fra 0 til 4, med højere score, der indikerer større fibrose (0=Ingen, 4=Cirrhose).
|
Uge 240
|
|
Procentdel af deltagere, der havde progression til skrumpelever i uge 48
Tidsramme: Uge 48
|
Progression til cirrhose blev defineret som en ændring i NASH CRN-fibrosestadiet fra < 4 ved baseline til 4 i uge 48.
|
Uge 48
|
|
Procentdel af deltagere, der havde NASH-resolution uden forværring af fibrose i uge 48
Tidsramme: Uge 48
|
NASH-opløsning blev defineret som lobulær inflammation på 0 eller 1 fra ≥ 1 ved baseline og hepatocellulær ballondannelse på 1 fra en værdi ≥ 1 ved baseline; begge kriterier var nødvendige betingelser.
Evaluerbare deltagere havde baseline lobulær inflammation og hepatocellulær ballondannelse ≥ 1. Forværring af fibrose blev defineret ved en stigning i fibrosestadiet fra 3 til 4 som defineret af NASH CRN.
|
Uge 48
|
|
Procentdel af deltagere, der havde NASH-resolution uden forværring af fibrose i uge 240
Tidsramme: Uge 240
|
NASH-opløsning blev defineret som lobulær inflammation på 0 eller 1 fra ≥ 1 ved baseline og hepatocellulær ballondannelse på 1 fra en værdi ≥ 1 ved baseline; begge kriterier var nødvendige betingelser.
Evaluerbare deltagere havde baseline lobulær inflammation og hepatocellulær ballondannelse ≥ 1. Forværring af fibrose blev defineret ved en stigning i fibrosestadiet fra 3 til 4 som defineret af NASH CRN.
|
Uge 240
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.
- Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.
- Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.
- Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.
- Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.
- Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.
- Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.
- Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.
- Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3 and STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.
- Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (FAKTISKE)
13. februar 2017
Primær færdiggørelse (FAKTISKE)
19. juni 2019
Studieafslutning (FAKTISKE)
19. juni 2019
Datoer for studieregistrering
Først indsendt
10. februar 2017
Først indsendt, der opfyldte QC-kriterier
10. februar 2017
Først opslået (FAKTISKE)
14. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (FAKTISKE)
29. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juni 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GS-US-384-1943
- 2016-004374-18 (EUDRACT_NUMBER)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .