Clinical Trial Details

Trial ID: L0212
Source ID: NCT03053050
Associated Drug: Selonsertib
Title: Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Acronym: STELLAR-3
Status: Terminated
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03053050/results
Conditions: Nonalcoholic Steatohepatitis
Interventions: Drug: SEL|Drug: Placebo to match SEL 6 mg|Drug: Placebo to match SEL 18 mg
Outcome Measures: Percentage of Participants Who Achieved a ??? 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48|Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event|Percentage of Participants Who Had Progression to Cirrhosis at Week 48|Percentage of Participants Who Had a ??? 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240|Percentage of Participants Who Had a ??? 1-Stage Improvement in Fibrosis at Week 48|Percentage of Participants Who Had a ??? 1-Stage Improvement in Fibrosis at Week 240|Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48|Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240
Sponsor/Collaborators: Gilead Sciences
Gender: All
Age: 18 Years to 70 Years ?? (Adult, Older Adult)
Phases: Phase 3
Enrollment: 808
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Care Provider)|Primary Purpose: Treatment
Start Date: February 13, 2017
Completion Date: June 19, 2019
Results First Posted: June 29, 2020
Last Update Posted: June 29, 2020
Locations: Institute of Liver Health, Chandler, Arizona, United States|Banner University Medical Center-Phoenix, Phoenix, Arizona, United States|St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States|Mayo Clinic, Phoenix, Arizona, United States|University of Arizona, Tucson, Arizona, United States|Baptist Medical Center, Little Rock, Arkansas, United States|Arkansas Gastroenterology, North Little Rock, Arkansas, United States|eStudySite, Chula Vista, California, United States|Southern California Liver Centers, Coronado, California, United States|United Gastroenterologists, Costa Mesa, California, United States|TriWest Research Associates, LLC, El Cajon, California, United States|Fresno Clinical Research Center, Fresno, California, United States|University of California San Diego (UCSD), La Jolla, California, United States|Ruane Clinical Research Group, Los Angeles, California, United States|Cedars Sinai Medical Center, Los Angeles, California, United States|VA Greater Los Angeles Healthcare System, Los Angeles, California, United States|eStudySite, Oceanside, California, United States|California Liver Institute, Pasadena, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|University of California, Davis Medical Center, Sacramento, California, United States|Medical Associates Research Group, San Diego, California, United States|Kaiser Permanente, San Diego, California, United States|California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant, San Francisco, California, United States|Mission Gastroenterology and Hepatology, San Francisco, California, United States|University of California San Francisco (UCSF), San Francisco, California, United States|Silicon Valley Research Institute, San Jose, California, United States|University of Colorado, Aurora, Colorado, United States|Yale University School of Medicine, New Haven, Connecticut, United States|Integrity Clinical Research, LLC, Doral, Florida, United States|UF Hepatology Research at CTRB, Gainesville, Florida, United States|UF Health Jacksonville-Gastroenterology Emerson, Jacksonville, Florida, United States|Florida Research Institute, Lakewood Ranch, Florida, United States|Sunrise Medical Research, Inc, Lauderdale Lakes, Florida, United States|Sunrise Research Institute, Miami, Florida, United States|Schiff Center for Liver Diseases/University of Miami, Miami, Florida, United States|Genoma Research Group, Inc, Miami, Florida, United States|Advanced Research Institute, New Port Richey, Florida, United States|Avail Clinical Research, LLC, Orange City, Florida, United States|South Florida Center of Gastroenterology, PA, Wellington, Florida, United States|Florida Medical Clinic, PA, Zephyrhills, Florida, United States|Digestive Healthcare of Georgia, Atlanta, Georgia, United States|Piedmont Transplant Institute, Atlanta, Georgia, United States|Gastrointestinal Specialists of Georgia, PC, Marietta, Georgia, United States|Northwestern Memorial Hospital; Clinical Research Unit, Chicago, Illinois, United States|The University of Chicago Medical Center, Chicago, Illinois, United States|NorthShore University Healthsystem, Glenview, Illinois, United States|Indiana University Health - University Hospital, Indianapolis, Indiana, United States|Indianapolis Gastroenterology Research Foundation, Indianapolis, Indiana, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|Gastroenterology Associates of Hazard, Hazard, Kentucky, United States|Delta Research Partners, LLC, Bastrop, Louisiana, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Ocshner Medical Center, New Orleans, Louisiana, United States|Louisiana Research Center, LLC, Shreveport, Louisiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Digestive Disease Associates, PA, Catonsville, Maryland, United States|Meritus Center for Clinical Research, Hagerstown, Maryland, United States|Henry Ford Health System, Detroit, Michigan, United States|Gastroenterology Associates of Western Michigan, P.L.C., Wyoming, Michigan, United States|Huron Gastroenterology Associates/Center for Digestive Care, Ypsilanti, Michigan, United States|University of Minnesota Medical Center - Fairview, Minneapolis, Minnesota, United States|Mayo Clinic, Rochester, Minnesota, United States|Southern Therapy and Advanced Research LLC (STAR), Ridgeland, Mississippi, United States|Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States|Kansas City Gastroenterology and Hepatology, Kansas City, Missouri, United States|Saint Louis University, Saint Louis, Missouri, United States|eStudySite, Las Vegas, Nevada, United States|Rutgers New Jersey Medical School- Doctors Office Center, Newark, New Jersey, United States|University of Buffalo, Clinical and Translational Research Center, Buffalo, New York, United States|Northwell Health - Sandra Atlas Bass Center for Liver Diseases, Manhasset, New York, United States|Icahn School of Medicine at Mount Sinai Beth Israel, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|University of North Carolina at Chapel Hill / UNC School of Medicine, Chapel Hill, North Carolina, United States|Duke University Medical Center - Duke South Clinics, Durham, North Carolina, United States|Cumberland Research Associates, LLC, Fayetteville, North Carolina, United States|Triad Clinical Trials LLC, Greensboro, North Carolina, United States|Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease, Huntersville, North Carolina, United States|PMG Research of Rocky Mount, LLC, Rocky Mount, North Carolina, United States|Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease, Statesville, North Carolina, United States|Digestive Health Specialists, PA, Winston-Salem, North Carolina, United States|Consultants for Clinical Research, Cincinnati, Ohio, United States|UC Health/Holmes Hospital, Cincinnati, Ohio, United States|Northeast Clinical Research Center, LLC, Bethlehem, Pennsylvania, United States|Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute, Pittsburgh, Pennsylvania, United States|VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania, United States|eStudySite, Pittsburgh, Pennsylvania, United States|Guthrie Medical Group, PC, Sayre, Pennsylvania, United States|University Gastroenterology, Providence, Rhode Island, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Greenville Health System - Gastroenterology and Liver Center, Greenville, South Carolina, United States|WR-ClinSearch, LLC, Chattanooga, Tennessee, United States|Gastro One, Germantown, Tennessee, United States|Quality Medical Research PLLC, Nashville, Tennessee, United States|Vanderbilt University Medical Center - Digestive Disease Center, Nashville, Tennessee, United States|Texas Clinical Research Institute, LLC, Arlington, Texas, United States|Pinnacle Clinical Research, PLLC, Austin, Texas, United States|Austin Center for Clinical Research, Austin, Texas, United States|The Liver Institute at Methodist Dallas Medical Center, Dallas, Texas, United States|Texas Digestive Disease Consultants, Dallas, Texas, United States|Baylor Scott & White All Saints Medical Center, Fort Worth, Texas, United States|Kelsey-Seybold Clinic, Houston, Texas, United States|Baylor College of Medicine - Advanced Liver Therapies, Houston, Texas, United States|VAMC & Baylor College, Houston, Texas, United States|Pinnacle Clinical Research, PLLC, Live Oak, Texas, United States|American Research Corporation, The Texas Liver Institute, San Antonio, Texas, United States|Intermountain Liver Disease and Transplant Center, Murray, Utah, United States|University of Utah Hospital, Salt Lake City, Utah, United States|The University of Vermont Medical Center, Burlington, Vermont, United States|University of Virginia Medical Center, Charlottesville, Virginia, United States|Verity Research, Inc., Fairfax, Virginia, United States|Inova Fairfax Medical Campus, Falls Church, Virginia, United States|Emeritas Research Group, Lansdowne Town Center, Virginia, United States|Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia, Newport News, Virginia, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia, Richmond, Virginia, United States|McGuire VA Medical Center, Richmond, Virginia, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Virginia Mason, Seattle, Washington, United States|Swedish Organ Transplant and Liver Center, Seattle, Washington, United States|Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, United States|Hospital Italiano de Buenos Aires, Buenos Aires, Argentina|Instituto Oulton, C??rdoba, Argentina|St. Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia|St. George's Hospital, Kogarah, New South Wales, Australia|Westmead Hospital, Westmead, New South Wales, Australia|Royal Brisbane & Women's Hospital, Herston, Queensland, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|Monash Health, Monash Medical Centre, Clayton, Victoria, Australia|St. Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia|Austin Hospital, Heidelberg, Victoria, Australia|The Alfred Hospital, Alfred Health, Melbourne, Victoria, Australia|Royal Perth Hospital, Perth, Western Australia, Australia|Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin, Graz, Austria|Allgemeines Krankenhaus Wien, Vienna, Austria|CUB Hopital Erasme, Brussels, Belgium|UZ Brussel, Brussel, Belgium|Universitaire Ziekenhuizen Leuven, Leuven, Belgium|Hospital das Cl??nicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP, Botucatu, Brazil|Hospital de Cl??nicas de Porto Alegre - HCPA/UFRGS, Porto Alegre, Brazil|Hospital das Cl??nicas da Faculdade de Medicina de Ribeir??o Preto - USP, Ribeir??o Preto, Brazil|Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo, S??o Paulo, Brazil|Universidade Federal de S??o Paulo / Unidade Ambulatorial de Pesquisa Cl??nica - I (UAPC-I), S??o Paulo, Brazil|University of Calgary Liver Unit (Heritage Medical Research Clinic), Calgary, Alberta, Canada|University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC), Edmonton, Alberta, Canada|LAIR Centre, Vancouver, British Columbia, Canada|Gordon and Leslie Diamond Health Care Centre, Vancouver, British Columbia, Canada|(G.I.R.I.) GI Research Institute, Vancouver, British Columbia, Canada|PerCuro Clinical Research Ltd., Victoria, British Columbia, Canada|South Shore Medical Arts, Bridgewater, Nova Scotia, Canada|William Osler Health System-Brampton Civic Hospital, Brampton, Ontario, Canada|South Shore Medical Arts, London, Ontario, Canada|Toronto Center for Liver Diseases (TCLD), Toronto General Hospital, Toronto, Ontario, Canada|Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC), Montr??al, Quebec, Canada|Centre Hospitalier Universitaire d'Angers, Angers, France|Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, France|Hopital Henri Mondor, Cr??teil, France|CHU de Grenoble- Hopital Michallon, Grenoble, France|Centre Hospitalier Regional Universitaire- Hopital Claude Huriez, Lille, France|CHU de Limoges- Hopital Dupuytren- Federation Hepatologie, Limoges, France|Hopital de la Croix Rousse, Lyon, France|H??pital Saint Joseph, Marseille, France|Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2, Nice, France|Hopital Cochin, Paris, France|Hopital Beaujon, Pessac, France|Centre Hospitalier Universitaire de Bordeaux, Pessac, France|Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil, Strasbourg, France|Centre Hospitalier Universitaire de Toulouse- Hopital Purpan, Toulouse, France|Hopital Paul Brousse, Villejuif, France|Uniklinik RWTH Aachen, Medizinische Klinik III, Aachen, Germany|Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp), Berlin, Germany|Universitatsklinikum Bonn (AoR), Bonn, Germany|Universitatsklinikum Frankfurt der Goethe-Universitat, Frankfurt, Germany|Medizinische Hochschule Hannover, Hanover, Germany|Uniklinikum des Saarlandes- Klinik fur Innere Medizin II, Homburg, Germany|Gastroenterologisch- Hepatologisches Zentrum Kiel, Kiel, Germany|Eugastro Gmbh, Leipzig, Germany|Johannes Gutenberg-Universitat, Mainz, Germany|Alice Ho Miu Ling Nethersole Hospital, Tai Po, Hong Kong|Tuen Mun Hospital, Tuen Mun, Hong Kong|Midas Multispecialty Hospital, Nagpur, Maharashtra, India|Institute of Post Graduate Medical Education and Research / SSKM Hospital, Kolkata, India|Kasturba Medical College (KMC) Hospital, Mangalore, India|Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.), Mumbai, India|Maharaja Agrasen Hospital, New Delhi, India|All India Institute of Medical Sciences, New Delhi, India|Fortis Flt. Lt. Rajan Dhall Hospital, New Delhi, India|Institute of Liver & Biliary Sciences, New Delhi, India|Rambam Health Care Campus, Haifa, Israel|The Lady Davis Carmel Medical Center, Haifa, Israel|Holy Family hospital, Nazaret, Israel|The Chaim Sheba Medical Center, Ramat Gan, Israel|Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy|Azienda Ospedaliera Universitaria Pisana, Pisa, Italy|IRCCS Ospedale Casa Sollievo Della Soferrenza, San Giovanni Rotondo, Italy|Chiba University Hospital, Chiba, Japan|Fukui-Ken Saiseikai Hospital, Fukui-shi, Japan|Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima, Japan|Hiroshima University Hospital, Hiroshima, Japan|Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan|Juntendo University Shizuoka Hospital, Izunokuni, Japan|Kagoshima University Medical And Dental Hospital, Kagoshima, Japan|Kanazawa University Hospital, Kanagawa, Japan|Nara Medical University Hospital, Kashihara, Japan|Toranomon Hospital Kajigaya, Kawasaki, Japan|Shinkokura Hospital, Kitakyushu, Japan|Kumamoto Shinto General Hospital, Kumamoto, Japan|Kurume University Hospital, Kurume, Japan|University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan|Shinshu University Hospital, Matsumoto, Japan|Toranomon Hospital, Minato, Japan|Miyazaki Medical Center Hospital, Miyazaki, Japan|Japanese Red Cross Musashino Hospital, Musashino, Japan|Aichi Medical University Hospital, Nagakute, Japan|Heart Life Hospital, Nakagami, Japan|Nara City Hospital, Nara, Japan|Hyogo College of Medicine Hospital, Nishinomiya, Japan|Kawasaki Medical School General Medical Center, Okayama, Japan|Okayama University Hospital, Okayama, Japan|National Hospital Organization Osaka National Hospital, Osaka, Japan|Saga University Hospital, Saga, Japan|Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital, Sapporo, Japan|Tohoku Rosai Hospital, Sendai, Japan|National Center for Global Health and Medicine Hospital, Shinjuku-ku, Japan|Saiseikai Suita Hospital, Suita, Japan|Kagawa Prefectural Central Hospital, Takamatsu, Japan|Mie University Hospital, Tsu, Japan|Ehime University Hospital, T??no, Japan|Yamagata University Hospital, Yamagata, Japan|Yokohama City University Hospital, Yokohama, Japan|National Hospital Organization Nagasaki Medical Center, ??mura, Japan|Hirakata Kohsai Hospital, ??saka, Japan|Keimyung University Dongsan Medical Center, Daegu, Korea, Republic of|Kyungpook National University Hospital, Daegu, Korea, Republic of|National Health Insurance Service- Ilsan Hospital, Goyang-si, Korea, Republic of|Hanyang University Seoul Hospital, Seoul, Korea, Republic of|Asan Medical Center, Seoul, Korea, Republic of|Chung-Ang University Hospital, Seoul, Korea, Republic of|Severance Hospital, Yonsei University Health System, Seoul, Korea, Republic of|Gangnam Severance Hospital, Seoul, Korea, Republic of|Korea University Guro Hospital, Seoul, Korea, Republic of|SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of|Yonsei University Wonju Severance Christian Hospital, W??nju, Korea, Republic of|Hospital Selayang, Batu Caves, Malaysia|University of Malaya Medical Centre, Kuala Lumpur, Malaysia|Phylasis Clinicas Research S. de RL de CV., Cuautitl??n, Mexico|Consultorio M??dico, Mexico City, Mexico|Investigaciones Medicas Cisneros SC, Monterrey, Mexico|University Medical Center Utrecht, Utrecht, Netherlands|Auckland City Hospital, Grafton, New Zealand|Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii, Bytom, Poland|Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, ????d??, Poland|Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E, Vila Real, Portugal|Klinical Investigations Group, LLC, San Juan, Puerto Rico|VA Caribbean Healthcare System, San Juan, Puerto Rico|Fundacion de Investigacion de Diego, San Juan, Puerto Rico|National University Hospital, Singapore, Singapore|Singapore General Hospital, Singapore, Singapore|Tan Tock Seng Hospital, Singapore, Singapore|Changi General Hospital Pte Ltd., Singapore, Singapore|Khoo Teck Puat Hospital, Singapore, Singapore|Hospital del Mar, Barcelona, Spain|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Hospital Clinic de Barcelona, Barcelona, Spain|Hospital Universitario La Paz, Madrid, Spain|Hospital Puerto de Hierro Majadahonda, Majadahonda, Spain|CHOP_Complejo Hospitalrio Universitario de Pontevedra, Pontevedra, Spain|Hospital Universitario Marques de Valdecilla, Santander, Spain|Hospital Universitario Virgen del Rocio, Sevilla, Spain|Hospital Universitari i Politecnic La Fe de Valencia, Valencia, Spain|Universit??tsklinik f??r Viszerale Chirurgie und Medizin, Inselspital, Hepatologie, Bern, Switzerland|Istituto Cantonale di Patologia Locarno, Lugano, Switzerland|Changhua Christian Hospital, Chang-hua, Taiwan|Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City, Taiwan|Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan|E-DA Hospital, Kaohsiung, Taiwan|Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan|Taichung Veterans General Hospital, Taichung, Taiwan|National Cheng Kung University Hospitalv, Tainan, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Mackay Memorial Hospital, Taipei, Taiwan|Cathay General Hospital, Taipei, Taiwan|Taipei Veterans General Hospital, Taipei, Taiwan|Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan|Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom|Derby Teaching Hospitals NHS FT, Derby, United Kingdom|University Hospitals Birmingham NHS Foundation Trust, Edgbaston, United Kingdom|King's College Hospital NHS Foundation Trust, London, United Kingdom|Imperial College Healthcare NHS Trust, London, United Kingdom|The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom|Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom|Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom|Abertawe Bro Morgannwg University Health Board, Swansea, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT03053050