Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (STELLAR-4)

April 24, 2020 updated by: Gilead Sciences

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

883

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • 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
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne
      • Heidelberg, Victoria, Australia, 3081
        • Austin Health
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital, Alfred Health
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • 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
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Ucl Saint-Luc
      • Bruxelles, Belgium, 10070
        • CUB Hôpital Erasme
      • Ghent, Belgium, 9000
        • Az Maria Middelares Ghent
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary Liver Unit (Heritage Medical Research Clinic)
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta
      • Edmonton, Alberta, Canada, T5H 4B9
        • GI Research
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1HZ
        • Lair Centre
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
      • Victoria, British Columbia, Canada, V8T 5G4
        • PerCuro Clinical Research Ltd.
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • University of Manitoba, Health Sciences Centre, John Buhler Research Centre
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • South Shore Medical Arts
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System-Brampton Civic Hospital
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Hamilton, Ontario, Canada, L8S 4L8
        • McMaster University Medical Centre
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
      • 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
      • Amiens, France, 80054
        • CHU Amiens Picardie
      • Angers, France, 49033
        • Centre Hospitalier Universitaire d'Angers
      • Clermont-Ferrand, France, 63003
        • Centre Hospitalier Universitaire Estaing
      • Créteil, France, 94010
        • Hopital Henri Mondor
      • Grenoble, France, 38043
        • CHU de Grenoble- Hopital Michallon
      • Lille, France, 59037
        • Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
      • Limoges, France, 87042
        • CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
      • Lyon, France, 69317
        • Hôpital de la Croix Rousse
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Montpellier, France, 34925
        • CHU De Montpellier, Hôpital St Eloi
      • Nice, France, 06200
        • Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75651
        • Groupe Hospitalier Universitaire La Pitie Salpetriere
      • Pessac, France, 33600
        • Hopital Beaujon
      • Strasbourg, France, 67091
        • Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH Aachen, Medizinische Klinik III
      • Bonn, Germany, 53105
        • Universitätsklinikum Bonn (AöR)
      • Frankfurt am main, Germany, 60590
        • Universitatsklinikum Frankfurt der Goethe-Universitat
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig AöR
      • Mainz, Germany, 55131
        • Johannes Gutenberg-Universität
  • Hong Kong
      • Sha Tin, Hong Kong
        • Prince of Wales Hospital
      • Tai Po, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
  • India
      • Chandigarh, India, 160012
        • Department of Hepatology PGIMER Chandigarh
      • Hyderabad, India, 500004
        • Global Clinical Reseaech Services PVT LTD
      • Kolkata, India, 700020
        • Institute of Post Graduate Medical Education and Research (IPGMER)
      • Ludhiana, India, 141001
        • Dayanand Medical College & Hospital
      • Mangalore, India, 575001
        • Kasturba Medical College Hospital
      • Mumbai, India, 400012
        • Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals
      • Nagpur, India, 440010
        • Midas Multispecialty Hospital
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110070
        • Fortis Flt. Lt. Rajan Dhall Hospital
      • New Delhi, India, 110070
        • Institute of Liver & Biliary Sciences
  • Israel
      • Afula, Israel, 18341
        • Emek Medical Center
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel Medical Center
      • Jerusalem, Israel, 64239
        • Shaare Zedek Medical Center
      • Petaẖ Tiqwa, Israel, 49100
        • Rabin Medical Center
      • 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
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
  • Japan
      • Fukui, Japan, 918-8503
        • Fukui-ken Saiseikai Hospital
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
      • Izunokuni, Japan, 410-2295
        • Juntendo University Shizuoka Hospital
      • Kanazawa, Japan, 920-8641
        • Kanazawa University Hospital
      • Kashihara, Japan, 634-8522
        • Nara Medical University Hospital
      • Kawasaki, Japan, 105-8470
        • Toranomon Hospital Kajigaya
      • 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
      • Nagakute, Japan, 480-1195
        • Aichi Medical University Hospital
      • Nara, Japan, 630-8305
        • Nara City Hospital
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Okayama, Japan, 700-8508
        • Kawasaki Medical School General Medical Center
      • Osaka, Japan, 573-0153
        • Hirakata kohsai Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Sapporo, Japan, 060-8648
        • Hokkaido University Hospital
      • Sapporo, Japan, 600033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
      • Shinjuku, Japan, 162-8666
        • Tokyo Womens Medical University Hospital
      • Suita, Japan, 565-0871
        • Osaka University Hospital
      • Suita, Japan, 564-0013
        • Saiseikai Suita Hospital
      • Tsu, Japan, 514-8507
        • Mie University Hospital
      • Tōno, Japan, 7910295
        • 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
  • 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
      • Incheon, Korea, Republic of, 22332
        • Inha University Hospital
      • Seongnam, Korea, Republic of, 463-707
        • Seoul National University Bundang 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, 07061
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 03830
        • Seoul National University Hospital
  • Mexico
      • Mexico City, Mexico, 6700
        • Consultorio Medico
      • Monterrey, Mexico, 64000
        • Accelerium S. de R.L. de C.V.
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
      • Dunedin, New Zealand, 9016
        • Southern District Health Board - Dunedin Hospital
  • Poland
      • Bytom, Poland, 41-902
        • Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
      • Mysłowice, Poland, 41-400
        • ID Clinic Arkadiusz Pisula
      • Łódź, Poland, 91-347
        • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
      • San Juan, Puerto Rico, 00921
        • Klinical Investigations Group, LLC
      • San Juan, Puerto Rico, 00921
        • VA Carribean Healthcare System
  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital Pte Ltd.
      • Singapore, Singapore, 169856
        • Singapore General Hospital
      • Singapore, Singapore, 169856
        • National University Health System
  • Spain
      • Alcorcón, Spain, 08036
        • Hospital Universitario Fundacion Alcorcon
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 8003
        • Hospital del Mar - Parc de Salut
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Majadahonda, Spain, 28220
        • Hospital Universitario Puerto de Hierro Majadahonda
      • Pontevedra, Spain, 36071
        • CHOP_Complejo Hospitalario Universitario de Pntevedra
      • 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
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
  • Switzerland
      • Bern, Switzerland, 3010
        • Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
      • Lugano, Switzerland, 6900
        • Istituto Cantanale di Patologia Locarno
  • Taiwan
      • Kaohsiung, Taiwan, 80099
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Tainan, Taiwan, 07428
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • NHS Greater Glasgow and Clyde
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust
      • London, United Kingdom, SW170QT
        • St. George's Hospital
      • London, United Kingdom, W2YN1
        • Imperial College Healthcare NHS Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Plymouth, United Kingdom, PL6 8DH
        • Plymouth 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
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Baptist Medical Center
      • North Little Rock, Arkansas, United States, 72117
        • Arkansas Gastroenterology
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Fresno, California, United States, 93720
        • Fresno Clinical Research Center
      • La Jolla, California, United States, 92037
        • Scripps Clinical Research Services
      • La Jolla, California, United States, 92093
        • University of California, San Diego (Altman Clinical and Translational Research Center)
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90036
        • Ruane Clinical Research Group
      • Los Angeles, California, United States, 90073
        • Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • Pasadena, California, United States, 91105
        • Huntington Medical Research Institutes (HMRI) Liver Center
      • 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, 92105
        • Research and Education, Inc.
      • San Diego, California, United States, 92123
        • Medical Associates Research Group
      • San Diego, California, United States, 92514
        • Kaiser Permanente
      • 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
        • eStudySite
      • San Francisco, California, United States, 94143
        • University of California, San Francisco-Liver Clinic
      • Ventura, California, United States, 93003
        • Island View Gastroenterology Associates- Ventura
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver and Hospital
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology, PC
    • Florida
      • Doral, Florida, United States, 33166
        • Integrity Clinical Research, LLC
      • Gainesville, Florida, United States, 32610
        • University of Florida Hepatology Research at CTRB
      • Homestead, Florida, United States, 33030
        • Clinical Research of Homestead
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Lakewood Ranch, Florida, United States, 34211
        • Florida Research Institute
      • Miami, Florida, United States, 33136
        • Schiff Center for Liver Diseases/University of Miami
      • Orlando, Florida, United States, 32804
        • Florida Hospital Transplant Institute
      • Palmetto, Florida, United States, 33157
        • IMIC Inc
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology, PA
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
      • 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
      • Columbus, Georgia, United States, 31904
        • Columbus Regional Research Institute
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates Of Central Georgia, LLC
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • 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 - Glenbrook ACC
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health - University Hospital
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center, P.C.
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Hazard, Kentucky, United States, 41707
        • Gastroenterology Associates Of Hazard
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Clinical Trials Unit
    • Louisiana
      • Bastrop, Louisiana, United States, 71021
        • Delta Research Partners
      • 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, 21742
        • Meritus Center for Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Medical School
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • 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 Research Institute
      • Saint Louis, Missouri, United States, 63104
        • Saint Louis University
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Rutgers New Jersey Medical School- Doctors Office Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • AccumetRx Clinical Research
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • 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, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • 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
        • NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Carolinas HealthCare System Center for Liver Disease
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center - Duke South Clinics
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates 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, 28677
        • Piedmont Healthcare
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45249
        • Consultants for Clinical Research
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Cleveland Medical Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University, The Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina, University Hospital
      • 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
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research PLLC
      • Nashville, Tennessee, United States, 37232
        • 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
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • 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
        • Research Specialists of Texas
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas, P.A.
      • Houston, Texas, United States, 77030
        • Smith Clinic
      • Live Oak, Texas, United States, 78233
        • Pinnacle Clinical Research
      • Richardson, Texas, United States, 75082
        • DHAT Research Institute
      • San Antonio, Texas, United States, 78215
        • American Research Corporation, The Texas Liver Institute
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Liver Disease and Transplant Clinic
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Vermont
      • Burlington, Vermont, United States, 05401
        • The University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Newport News, Virginia, United States, 23226
        • 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
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason
      • Seattle, Washington, United States, 98104
        • Swedish Organ Transplant and Liver Center

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 cirrhosis (F4 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, as determined by the central laboratory:

    • 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
    • HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to be resulted)
    • International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation
    • Platelet count ≥ 100,000/μL

Key Exclusion Criteria:

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 7, 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-antitrypsin 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEL 6 mg

Randomized Phase: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks.

Open-Label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily 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
Experimental: SEL 18 mg

Randomized Phase: SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks.

Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily 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
Placebo Comparator: Placebo

Randomized Phase: Placebo to match SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks.

Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily 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 Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH
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 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 NASH Resolution 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 reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions. 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. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.
Week 48
Percentage of Participants Who Had NASH Resolution 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 reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions.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. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.
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)

January 30, 2017

Primary Completion (Actual)

May 6, 2019

Study Completion (Actual)

May 6, 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)

May 7, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-384-1944
  • 2016-004148-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

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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