Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (STELLAR-3)

June 10, 2020 updated by: Gilead Sciences

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

808

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 450
        • Hospital Italiano de Buenos Aires
      • Córdoba, Argentina, X5000JJS
        • Instituto Oulton
  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney
      • Kogarah, New South Wales, Australia, 2217
        • St. George's Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane & Women's Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Health, Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital, Alfred Health
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Austria
      • Graz, Austria, A-8036
        • Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
      • Vienna, Austria, 1090
        • Allgemeines Krankenhaus Wien
  • Belgium
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1070
        • CUB Hôpital Erasme
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
  • Brazil
      • Botucatu, Brazil, 18618-000
        • Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
      • Porto Alegre, Brazil, CEP 90035-903
        • Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
      • Ribeirão Preto, Brazil, 14048-900
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
      • São Paulo, Brazil, 01246-903
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
      • São Paulo, Brazil, 04040-003
        • Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary Liver Unit (Heritage Medical Research Clinic)
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon and Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
      • Vancouver, British Columbia, Canada, V5Z 1H2
        • Lair Centre
      • Victoria, British Columbia, Canada, V8T 5G4
        • PerCuro Clinical Research Ltd.
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • South Shore Medical Arts
    • Ontario
      • Brampton, Ontario, Canada
        • William Osler Health System-Brampton Civic Hospital
      • London, Ontario, Canada, N6A 5A5
        • South Shore Medical Arts
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
    • Quebec
      • Montréal, Quebec, Canada, H4A 3JI
        • Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
  • France
      • Angers, France, 49033
        • Centre Hospitalier Universitaire d'Angers
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Universitaire Estaing
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • Grenoble, France, 38043
        • CHU de Grenoble- Hopital Michallon
      • Lille, France, 59000
        • Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
      • Limoges, France, 87000
        • CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
      • Lyon, France, 69317
        • Hopital de la croix rousse
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Nice, France, 06200
        • Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
      • Paris, France, 75014
        • Hôpital Cochin
      • Pessac, France, 33604
        • Centre Hospitalier Universitaire de Bordeaux
      • Pessac, France, 33600
        • Hôpital Beaujon
      • Strasbourg, France, 67091
        • Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
      • Villejuif, France, 94800
        • Hôpital Paul Brousse
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen, Medizinische Klinik III
      • Berlin, Germany, 13353
        • Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn (AöR)
      • Frankfurt, Germany, 60590
        • Universitatsklinikum Frankfurt der Goethe-Universitat
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Homburg, Germany, 66421
        • Uniklinikum des Saarlandes- Klinik fur Innere Medizin II
      • Kiel, Germany, 24146
        • Gastroenterologisch- Hepatologisches Zentrum Kiel
      • Leipzig, Germany, 04103
        • Eugastro GmbH
      • Mainz, Germany, 55131
        • Johannes Gutenberg-Universität
  • Hong Kong
      • Tai Po, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
      • Tuen Mun, Hong Kong
        • Tuen Mun Hospital
  • India
      • Kolkata, India, 700020
        • Institute of Post Graduate Medical Education and Research / SSKM Hospital
      • Mangalore, India, 575001
        • Kasturba Medical College (KMC) Hospital
      • Mumbai, India, 400012
        • Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110026
        • Maharaja Agrasen Hospital
      • New Delhi, India, 110070
        • Fortis Flt. Lt. Rajan Dhall Hospital
      • New Delhi, India, 110070
        • Institute of Liver & Biliary Sciences
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Midas Multispecialty Hospital
  • Israel
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel Medical Center
      • Haifa, Israel, 30196
        • Rambam Health Care Campus
      • Nazaret, Israel, 91008
        • Holy Family Hospital
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • Italy
      • Milan, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Pisa, Italy, 56124
        • Azienda Ospedaliera Universitaria Pisana
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS Ospedale Casa Sollievo Della Soferrenza
  • Japan
      • Chiba, Japan, 260-8670
        • Chiba University Hospital
      • Fukui-shi, Japan, 918-8503
        • Fukui-ken Saiseikai Hospital
      • Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Ibaraki, Japan, 300-0395
        • Tokyo Medical University Ibaraki Medical Center
      • Izunokuni, Japan, 410-2295
        • Juntendo University Shizuoka Hospital
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Medical and Dental Hospital
      • Kanagawa, Japan, 920-8641
        • Kanazawa University Hospital
      • Kashihara, Japan, 634-8522
        • Nara Medical University Hospital
      • Kawasaki, Japan, 105-8470
        • Toranomon Hospital Kajigaya
      • Kitakyushu, Japan, 803-8505
        • Shinkokura Hospital
      • Kumamoto, Japan, 862-8655
        • Kumamoto Shinto General Hospital
      • Kurume, Japan, 830-0011
        • Kurume University Hospital
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Matsumoto, Japan, 390-8621
        • Shinshu University Hospital
      • Minato, Japan, 105-8470
        • Toranomon Hospital
      • Miyazaki, Japan, 880-0003
        • Miyazaki Medical Center Hospital
      • Musashino, Japan, 180-8610
        • Japanese Red Cross Musashino Hospital
      • Nagakute, Japan, 480-1195
        • Aichi Medical University Hospital
      • Nakagami, Japan, 901-2492
        • Heart Life Hospital
      • Nara, Japan, 630-8305
        • Nara City Hospital
      • Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Okayama, Japan, 700-808
        • Kawasaki Medical School General Medical Center
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Sapporo, Japan, 600-0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
      • Sendai, Japan, 981-8563
        • Tohoku Rosai Hospital
      • Shinjuku-ku, Japan, 162-8655
        • National Center for Global Health and Medicine Hospital
      • Suita, Japan, 564-0013
        • Saiseikai Suita Hospital
      • Takamatsu, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Tsu, Japan, 514-8507
        • Mie University Hospital
      • Tōno, Japan, 7190295
        • Ehime University Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
      • Yokohama, Japan, 236-0004
        • Yokohama City University Hospital
      • Ōmura, Japan, 856-8562
        • National Hospital Organization Nagasaki Medical Center
      • Ōsaka, Japan, 573-0153
        • Hirakata kohsai Hospital
  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of, 41931
        • Keimyung University Dongsan Medical Center
      • Goyang-si, Korea, Republic of, 10444
        • National Health Insurance Service- Ilsan Hospital
      • Seoul, Korea, Republic of, 135-720
        • Gangnam Severance Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 06973
        • Chung-Ang University Hospital
      • Seoul, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of, 120-752
        • Severance Hospital, Yonsei University Health System
      • Seoul, Korea, Republic of, 37061
        • SMG-SNU Boramae Medical Center
      • Wŏnju, Korea, Republic of, 26426
        • Yonsei University Wonju Severance Christian Hospital
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Hospital Selayang
      • Kuala Lumpur, Malaysia, 50603
        • University of Malaya Medical Centre
  • Mexico
      • Cuautitlán, Mexico, 54769
        • Phylasis Clinicas Research S. de RL de CV.
      • Mexico City, Mexico, 6700
        • Consultorio Medico
      • Monterrey, Mexico, 64000
        • Investigaciones Medicas Cisneros SC
  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • University Medical Center Utrecht
  • New Zealand
      • Grafton, New Zealand, 1023
        • Auckland City Hospital
  • Poland
      • Bytom, Poland, 41-902
        • Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
      • Łódź, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
  • Portugal
      • Vila Real, Portugal, 5000
        • Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
      • San Juan, Puerto Rico, 00921
        • VA Caribbean Healthcare System
      • San Juan, Puerto Rico, 00907
        • Klinical Investigations Group, LLC
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital Pte Ltd.
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 169856
        • Singapore General Hospital
      • Singapore, Singapore, 768828
        • Khoo Teck Puat Hospital
  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Majadahonda, Spain, 28220
        • Hospital Puerto de Hierro Majadahonda
      • Pontevedra, Spain, 36071
        • CHOP_Complejo Hospitalrio Universitario de Pontevedra
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Switzerland
      • Bern, Switzerland, 3010
        • Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
      • Lugano, Switzerland, 6900
        • Istituto Cantonale di Patologia Locarno
  • Taiwan
      • Chang-hua, Taiwan, 500
        • Changhua Christian Hospital
      • Chiayi City, Taiwan, 60002
        • Ditmanson Medical Foundation Chia-Yi Christian Hospital
      • Kaohsiung, Taiwan, 82445
        • E-DA Hospital
      • Kaohsiung, Taiwan, 80099
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Keelung, Taiwan, 20401
        • Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 7428
        • National Cheng Kung University Hospitalv
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 10630
        • Cathay General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taoyuan, Taiwan, 33305
        • Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Derby, United Kingdom, DE22 3NE
        • Derby Teaching Hospitals NHS FT
      • Edgbaston, United Kingdom, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom, W21NY
        • Imperial College Healthcare NHS Trust
      • Newcastle upon Tyne, United Kingdom, NE2 3HH
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals NHS Trust
      • Swansea, United Kingdom, SA2 8QA
        • Abertawe Bro Morgannwg University Health Board
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Institute of Liver Health
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center-Phoenix
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Baptist Medical Center
      • North Little Rock, Arkansas, United States, 72204
        • Arkansas Gastroenterology
    • California
      • Chula Vista, California, United States, 91911
        • eStudySite
      • Coronado, California, United States, 92673
        • Southern California Liver Centers
      • Costa Mesa, California, United States, 92626
        • United Gastroenterologists
      • El Cajon, California, United States, 92020
        • TriWest Research Associates, LLC
      • Fresno, California, United States, 93720
        • Fresno Clinical Research Center
      • La Jolla, California, United States, 92103
        • University of California San Diego (UCSD)
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, United States, 90073
        • VA Greater Los Angeles Healthcare System
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research Group
      • Oceanside, California, United States, 92056
        • eStudySite
      • Pasadena, California, United States, 91105
        • California Liver Institute
      • Rialto, California, United States, 92377
        • Inland Empire Liver Foundation
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92514
        • Kaiser Permanente
      • San Francisco, California, United States, 94143
        • University of California San Francisco (UCSF)
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
      • San Francisco, California, United States, 94115
        • Mission Gastroenterology and Hepatology
      • San Jose, California, United States, 95128
        • Silicon Valley Research Institute
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • Doral, Florida, United States, 33166
        • Integrity Clinical Research, LLC
      • Gainesville, Florida, United States, 32610
        • UF Hepatology Research at CTRB
      • Jacksonville, Florida, United States, 32207
        • UF Health Jacksonville-Gastroenterology Emerson
      • Lakewood Ranch, Florida, United States, 34211
        • Florida Research Institute
      • Lauderdale Lakes, Florida, United States, 33319
        • Sunrise Medical Research, Inc
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases/University of Miami
      • Miami, Florida, United States, 33165
        • Genoma Research Group, Inc
      • Miami, Florida, United States, 33130
        • Sunrise Research Institute
      • New Port Richey, Florida, United States, 34653
        • Advanced Research Institute
      • Orange City, Florida, United States, 32763
        • Avail Clinical Research, LLC
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology, PA
      • Zephyrhills, Florida, United States, 33540
        • Florida Medical Clinic, PA
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Transplant Institute
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital; Clinical Research Unit
      • Chicago, Illinois, United States, 60615
        • The University of Chicago Medical Center
      • Glenview, Illinois, United States, 60026
        • Northshore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health - University Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University Of Kansas Medical Center
    • Kentucky
      • Hazard, Kentucky, United States, 41707
        • Gastroenterology Associates Of Hazard
    • Louisiana
      • Bastrop, Louisiana, United States, 71021
        • Delta Research Partners, LLC
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Health Sciences Center
      • New Orleans, Louisiana, United States, 70121
        • Ocshner Medical Center
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center
      • Catonsville, Maryland, United States, 21228
        • Digestive Disease Associates, PA
      • Hagerstown, Maryland, United States, 21472
        • Meritus Center for Clinical Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates/Center for Digestive Care
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center - Fairview
      • Rochester, Minnesota, United States, 55095
        • Mayo Clinic
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • Southern Therapy and Advanced Research LLC (STAR)
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, United States, 64131
        • Kansas City Gastroenterology and Hepatology
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • eStudySite
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Rutgers New Jersey Medical School- Doctors Office Center
    • New York
      • Buffalo, New York, United States, 14230
        • University of Buffalo, Clinical and Translational Research Center
      • Manhasset, New York, United States, 11030
        • Northwell Health - Sandra Atlas Bass Center for Liver Diseases
      • New York, New York, United States, 10003
        • Icahn School of Medicine at Mount Sinai Beth Israel
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill / UNC School of Medicine
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center - Duke South Clinics
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates, LLC
      • Greensboro, North Carolina, United States, 27410
        • Triad Clinical Trials LLC
      • Huntersville, North Carolina, United States, 28078
        • Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount, LLC
      • Statesville, North Carolina, United States, 28625
        • Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Consultants for Clinical Research
      • Cincinnati, Ohio, United States, 45267
        • UC Health/Holmes Hospital
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Northeast Clinical Research Center, LLC
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
      • Pittsburgh, Pennsylvania, United States, 15251
        • eStudySite
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group, PC
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • South Carolina
      • Charleston, South Carolina, United States, 29245
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System - Gastroenterology and Liver Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-Clinsearch, LLC
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research PLLC
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center - Digestive Disease Center
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • Austin, Texas, United States, 78756
        • Austin Center for Clinical Research
      • Austin, Texas, United States, 78746
        • Pinnacle Clinical Research, PLLC
      • Dallas, Texas, United States, 75203
        • The Liver Institute at Methodist Dallas Medical Center
      • Dallas, Texas, United States, 75246
        • Texas Digestive Disease Consultants
      • Fort Worth, Texas, United States, 76104
        • Baylor Scott & White All Saints Medical Center
      • Houston, Texas, United States, 77025
        • Kelsey-Seybold Clinic
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Advanced Liver Therapies
      • Houston, Texas, United States, 77030
        • VAMC & Baylor College
      • Live Oak, Texas, United States, 78233
        • Pinnacle Clinical Research, PLLC
      • San Antonio, Texas, United States, 78215
        • American Research Corporation, The Texas Liver Institute
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Liver Disease and Transplant Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • The University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Fairfax, Virginia, United States, 22031
        • Verity Research, Inc.
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Lansdowne Town Center, Virginia, United States, 20716
        • Emeritas Research Group
      • Newport News, Virginia, United States, 23602
        • Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center
      • Richmond, Virginia, United States, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason
      • Seattle, Washington, United States, 98104
        • Swedish Organ Transplant and Liver Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Memorial Lutheran Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader

  • Has the following laboratory parameters at the screening visit:

    • Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
    • Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
    • Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
    • Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic anti-coagulation
  • Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
  • Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology.
  • History of liver transplantation
  • Current or history of hepatocellular carcinoma (HCC)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SEL 18 mg

Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks

Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Drug: SEL
Tablets administered orally once daily
Other Names:
  • selonsertib
  • GS-4997
Drug: Placebo to match SEL 6 mg
Tablets administered orally once daily
EXPERIMENTAL: SEL 6 mg

Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks

OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Drug: SEL
Tablets administered orally once daily
Other Names:
  • selonsertib
  • GS-4997
Drug: Placebo to match SEL 18 mg
Tablets administered orally once daily
PLACEBO_COMPARATOR: Placebo

Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks

OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Drug: Placebo to match SEL 18 mg
Tablets administered orally once daily
Drug: Placebo to match SEL 6 mg
Tablets administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Week 48
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
Week 48
Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event
Time Frame: Week 240
EFS was assessed by the time to the first clinical event, including progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.
Week 240

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240
Time Frame: Week 240
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
Week 240
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48
Time Frame: Week 48
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Week 48
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240
Time Frame: Week 240
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
Week 240
Percentage of Participants Who Had Progression to Cirrhosis at Week 48
Time Frame: Week 48
Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from < 4 at baseline to 4 at Week 48.
Week 48
Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48
Time Frame: Week 48
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
Week 48
Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240
Time Frame: Week 240
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
Week 240

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 13, 2017

Primary Completion (ACTUAL)

June 19, 2019

Study Completion (ACTUAL)

June 19, 2019

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (ACTUAL)

February 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-384-1943
  • 2016-004374-18 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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