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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03053063
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Drug: SEL Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 883 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019


Arm Intervention/treatment
Experimental: SEL 6 mg
SEL 6 mg plus placebo for up to 240 weeks
Drug: SEL
Tablets administered orally once daily
Other Names:
  • selonsertib
  • GS-4997

Drug: Placebo
Tablets administered orally once daily

Experimental: SEL 18 mg
SEL 18 mg plus placebo for up to 240 weeks
Drug: SEL
Tablets administered orally once daily
Other Names:
  • selonsertib
  • GS-4997

Drug: Placebo
Tablets administered orally once daily

Placebo Comparator: Placebo
Placebo for up to 240 weeks
Drug: Placebo
Tablets administered orally once daily




Primary Outcome Measures :
  1. Proportion of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the NASH Clinical Research Network (CRN) Classification Without Worsening of NASH [ Time Frame: Week 48 ]
  2. Event-Free Survival (EFS) at Week 240 as Assessed by Time to the First Clinical Event [ Time Frame: Week 240 ]

Secondary Outcome Measures :
  1. Proportion of Participants Who have a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240 [ Time Frame: Week 240 ]
  2. Proportion of Participants Who Have a ≥ 1-Stage Improvement in Fibrosis at Week 48 [ Time Frame: Week 48 ]
  3. Proportion of Participants Who Have a ≥ 1-Stage Improvement in Fibrosis at Week 240 [ Time Frame: Week 240 ]
  4. Proportion of Participants Who Have NASH Resolution at Week 48 [ Time Frame: Week 48 ]
  5. Proportion of Participants Who Have NASH Resolution at Week 240 [ Time Frame: Week 240 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 μmol if HbA1c is unable to be resulted)

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-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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053063


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Locations
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United States, Arizona
Institute of Liver Health
Chandler, Arizona, United States, 85224
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Arkansas
Baptist Medical Center
Little Rock, Arkansas, United States, 72204
Arkansas Gastroenterology
North Little Rock, Arkansas, United States, 72117
United States, California
Southern California Research Center
Coronado, California, United States, 92118
Fresno Clinical Research Center
Fresno, California, United States, 93720
Scripps Clinical Research Services
La Jolla, California, United States, 92037
University of California, San Diego (Altman Clinical and Translational Research Center)
La Jolla, California, United States, 92093
Ruane Clinical Research Group
Los Angeles, California, United States, 90036
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center
Los Angeles, California, United States, 90073
California Liver Research Institute
Pasadena, California, United States, 91105
Huntington Medical Research Institutes (HMRI) Liver Center
Pasadena, California, United States, 91105
Inland Empire Liver Foundation
Rialto, California, United States, 92377
University of California, Davis Medical Center
Sacramento, California, United States, 95817
Research and Education, Inc.
San Diego, California, United States, 92105
Medical Associates Research Group
San Diego, California, United States, 92123
Kaiser Permanente
San Diego, California, United States, 92514
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, 94115
University of California, San Francisco-Liver Clinic
San Francisco, California, United States, 94143
Island View Gastroenterology Associates- Ventura
Ventura, California, United States, 93003
United States, Colorado
University of Colorado Denver and Hospital
Aurora, Colorado, United States, 80045
South Denver Gastroenterology, PC
Englewood, Colorado, United States, 80113
United States, Florida
Integrity Clinical Research, LLC
Doral, Florida, United States, 33166
University of Florida Hepatology Research at CTRB
Gainesville, Florida, United States, 32610
Clinical Research of Homestead
Homestead, Florida, United States, 33030
Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Florida Research Institute
Lakewood Ranch, Florida, United States, 34211
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States, 33136
Florida Hospital Transplant Institute
Orlando, Florida, United States, 32804
IMIC Inc
Palmetto, Florida, United States, 33157
South Florida Center of Gastroenterology, PA
Wellington, Florida, United States, 33414
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Florida Medical Clinic, PA
Zephyrhills, Florida, United States, 33540
United States, Georgia
Digestive Healthcare of Georgia
Atlanta, Georgia, United States, 30309
Piedmont Transplant Institute
Atlanta, Georgia, United States, 30309
Columbus Regional Research Institute
Columbus, Georgia, United States, 31904
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern Memorial Hospital; Clinical Research Unit
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University of Chicago Medical Center
Chicago, Illinois, United States, 60615
NorthShore University HealthSystem - Glenbrook ACC
Glenview, Illinois, United States, 60026
United States, Indiana
Indiana University Health - University Hospital
Indianapolis, Indiana, United States, 46202
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States, 46237
United States, Iowa
Iowa Digestive Disease Center, P.C.
Clive, Iowa, United States, 50325
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Kentucky
Gastroenterology Associates of Hazard
Hazard, Kentucky, United States, 41707
University of Louisville Clinical Trials Unit
Louisville, Kentucky, United States, 40202
United States, Louisiana
Delta Research Partners
Bastrop, Louisiana, United States, 71021
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ocshner Medical Center
New Orleans, Louisiana, United States, 70121
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Digestive Disease Associates, PA
Catonsville, Maryland, United States, 21228
Meritus Center for Clinical Research
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States, 49519
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
Southern Therapy and Advanced Research LLC (STAR)
Ridgeland, Mississippi, United States, 39157
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Saint Louis University
Saint Louis, Missouri, United States, 63104
United States, New Jersey
Rutgers New Jersey Medical School- Doctors Office Center
Newark, New Jersey, United States, 07102
United States, New Mexico
AccumetRx Clinical Research
Albuquerque, New Mexico, United States, 87109
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
University of Buffalo, Clinical and Translational Research Center
Buffalo, New York, United States, 14230
Northwell Health - Sandra Atlas Bass Center for Liver Diseases
Manhasset, New York, United States, 11030
Icahn School of Medicine at Mount Sinai Beth Israel
New York, New York, United States, 10003
NYU Langone Medical Center
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10021
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Carolinas HealthCare System Center for Liver Disease
Charlotte, North Carolina, United States, 28204
Duke University Medical Center - Duke South Clinics
Durham, North Carolina, United States, 27710
Cumberland Research Associates LLC
Fayetteville, North Carolina, United States, 28304
Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
Huntersville, North Carolina, United States, 28078
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States, 27804
Piedmont Healthcare
Statesville, North Carolina, United States, 28677
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45249
University of Cincinnati
Cincinnati, Ohio, United States, 45267
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Penn State University, The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
United States, South Carolina
Medical University of South Carolina, University Hospital
Charleston, South Carolina, United States, 29425
Greenville Health System Gastroenterology and Liver Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
Gastro One
Germantown, Tennessee, United States, 38138
Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research
Memphis, Tennessee, United States, 38104
Quality Medical Research PLLC
Nashville, Tennessee, United States, 37211
Vanderbilt University Medical Center - Digestive Disease Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Pinnacle Clinical Research, PLLC
Austin, Texas, United States, 78746
Austin Center for Clinical Research
Austin, Texas, United States, 78756
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Texas Digestive Disease Consultants
Dallas, Texas, United States, 75246
Kelsey-Seybold Clinic
Houston, Texas, United States, 77025
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States, 77030
Houston Methodist Hospital
Houston, Texas, United States, 77030
Liver Associates of Texas, P.A.
Houston, Texas, United States, 77030
Research Specialists of Texas
Houston, Texas, United States, 77030
Smith Clinic
Houston, Texas, United States, 77030
Pinnacle Clinical Research
Live Oak, Texas, United States, 78233
DHAT Research Institute
Richardson, Texas, United States, 75082
American Research Corporation, The Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Utah
Intermountain Liver Disease and Transplant Clinic
Murray, Utah, United States, 84107
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Vermont
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Newport News, Virginia, United States, 23226
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Virginia Mason
Seattle, Washington, United States, 98101
Swedish Organ Transplant and Liver Center
Seattle, Washington, United States, 98104
University of Washington
Seattle, Washington, United States, 98195
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
St. George's Hospital
Kogarah, New South Wales, Australia, 2217
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Austin Health
Heidelberg, Victoria, Australia, 3081
The Alfred Hospital, Alfred Health
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Austria
Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
Graz, Austria, A-8036
Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
Belgium
UZ Brussel
Brussels, Belgium, 1090
Cliniques Universitaires UCL Saint-Luc
Brussels, Belgium, 1200
CUB Hopital Erasme
Bruxelles, Belgium, 10070
Az Maria Middelares Ghent
Ghent, Belgium, 9000
UZ Leuven
Leuven, Belgium, 3000
Canada, Alberta
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary, Alberta, Canada, T2N 4Z6
GI Research
Edmonton, Alberta, Canada, T5H 4B9
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
Canada, British Columbia
LAIR Centre
Vancouver, British Columbia, Canada, V5Z 1HZ
Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
Vancouver, British Columbia, Canada, V5Z 1M9
PerCuro Clinical Research Ltd.
Victoria, British Columbia, Canada, V8T 5G4
Canada, Manitoba
University of Manitoba, Health Sciences Centre, John Buhler Research Centre
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Nova Scotia
South Shore Medical Arts
Bridgewater, Nova Scotia, Canada, B4V 3N2
Canada, Ontario
William Osler Health System-Brampton Civic Hospital
Brampton, Ontario, Canada, L6R 3J7
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8S 4L8
London Health Sciences Centre - University Hospital
London, Ontario, Canada, N6A 5A5
Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
Canada, Quebec
Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
Montréal, Quebec, Canada, H4A 3JI
France
CHU Amiens Picardie
Amiens, France, 80054
Centre Hospitalier Universitaire d'Angers
Angers, France, 49033
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, France, 63003
Hopital Henri Mondor
Créteil, France, 94010
CHU de Grenoble- Hopital Michallon
Grenoble, France, 38043
Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
Lille, France, 59037
CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
Limoges, France, 87042
Hopital de la Croix Rousse
Lyon, France, 69317
Hôpital Saint Joseph
Marseille, France, 13008
CHU de Montpellier, Hopital St Eloi
Montpellier, France, 34925
Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
Nice, France, 06200
Hopital Cochin
Paris, France, 75014
Groupe Hospitalier Universitaire La Pitie Salpetriere
Paris, France, 75651
Hopital Beaujon
Pessac, France, 33600
Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
Strasbourg, France, 67091
Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
Toulouse, France, 31059
Germany
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, Germany, 52074
Universitatsklinikum Bonn (AoR)
Bonn, Germany, 53105
Universitatsklinikum Frankfurt der Goethe-Universitat
Frankfurt am main, Germany, 60590
Universitatsklinikum Leipzig AoR
Leipzig, Germany, 04103
Johannes Gutenberg-Universitat
Mainz, Germany, 55131
Hong Kong
Prince of Wales Hospital
Sha Tin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
India
Department of Hepatology PGIMER Chandigarh
Chandigarh, India, 160012
Global Clinical Reseaech Services PVT LTD
Hyderabad, India, 500004
Institute of Post Graduate Medical Education and Research (IPGMER)
Kolkata, India, 700020
Dayanand Medical College & Hospital
Ludhiana, India, 141001
Kasturba Medical College Hospital
Mangalore, India, 575001
Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals
Mumbai, India, 400012
Midas Multispecialty Hospital
Nagpur, India, 440010
All India Institute of Medical Sciences
New Delhi, India, 110029
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, India, 110070
Institute of Liver & Biliary Sciences
New Delhi, India, 110070
Israel
Emek Medical Center
Afula, Israel, 18341
Rambam Health Care Campus
Haifa, Israel, 31096
The Lady Davis Carmel Medical Center
Haifa, Israel, 3436212
Shaare Zedek Medical Center
Jerusalem, Israel, 64239
Rabin Medical Center
Petaẖ Tiqwa, Israel, 49100
The Chaim Sheba Medical Center
Ramat Gan, Israel, 52621
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
Japan
Fukui-Ken Saiseikai Hospital
Fukui, Japan, 918-8503
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, Japan, 730-8619
Juntendo University Shizuoka Hospital
Izunokuni, Japan, 410-2295
Kanazawa University Hospital
Kanazawa, Japan, 920-8641
Nara Medical University Hospital
Kashihara, Japan, 634-8522
Toranomon Hospital Kajigaya
Kawasaki, Japan, 105-8470
Kumamoto Shinto General Hospital
Kumamoto, Japan, 862-8655
Kurume University Hospital
Kurume, Japan, 830-0011
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Shinshu University Hospital
Matsumoto, Japan, 390-8621
Toranomon Hospital
Minato, Japan, 105-8470
Miyazaki Medical Center Hospital
Miyazaki, Japan, 880-0003
Aichi Medical University Hospital
Nagakute, Japan, 480-1195
Nara City Hospital
Nara, Japan, 630-8305
Kawasaki Medical School General Medical Center
Okayama, Japan, 700-8508
Okayama University Hospital
Okayama, Japan, 700-8558
Hirakata Kohsai Hospital
Osaka, Japan, 573-0153
Saga University Hospital
Saga, Japan, 849-8501
Hokkaido University Hospital
Sapporo, Japan, 060-8648
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, Japan, 600033
Tokyo Womens Medical University Hospital
Shinjuku, Japan, 162-8666
Saiseikai Suita Hospital
Suita, Japan, 564-0013
Osaka University Hospital
Suita, Japan, 565-0871
Mie University Hospital
Tsu, Japan, 514-8507
Ehime University Hospital
Tōno, Japan, 7910295
Yamagata University Hospital
Yamagata, Japan, 990-9585
Yokohama City University Hospital
Yokohama, Japan, 236-0004
National Hospital Organization Nagasaki Medical Center
Ōmura, Japan, 856-8562
Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of, 41931
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
National Health Insurance Service- Ilsan Hospital
Goyang-si, Korea, Republic of, 10444
Inha University Hospital
Incheon, Korea, Republic of, 22332
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Korea, Republic of, 03830
Asan Medical Center
Seoul, Korea, Republic of, 05505
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 07061
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Mexico
Consultorio Médico
Mexico City, Mexico, 6700
Accelerium S. de R.L. de C.V.
Monterrey, Mexico, 64000
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1023
Southern District Health Board - Dunedin Hospital
Dunedin, New Zealand, 9016
Poland
Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
Bytom, Poland, 41-902
ID Clinic Arkadiusz Pisula
Mysłowice, Poland, 41-400
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
Łódź, Poland, 91-347
Puerto Rico
Klinical Investigations Group, LLC
San Juan, Puerto Rico, 00921
VA Carribean Healthcare System
San Juan, Puerto Rico, 00921
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Singapore
National University Health System
Singapore, Singapore, 169856
Singapore General Hospital
Singapore, Singapore, 169856
Changi General Hospital Pte Ltd.
Singapore, Singapore, 529889
Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Spain, 08036
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital del Mar - Parc de Salut
Barcelona, Spain, 8003
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Puerto de Hierro Majadahonda
Majadahonda, Spain, 28220
CHOP_Complejo Hospitalario Universitario de Pntevedra
Pontevedra, Spain, 36071
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Consorcio Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain, 46026
Switzerland
Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
Bern, Switzerland, 3010
Istituto Cantanale di Patologia Locarno
Lugano, Switzerland, 6900
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 80099
National Cheng Kung University Hospital
Tainan, Taiwan, 07428
National Taiwan University Hospital
Taipei, Taiwan, 10002
Chang Gung Medical Foundation-LinKou Branch
Taoyuan, Taiwan, 333
United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G51 4TF
Barts Health NHS Trust
London, United Kingdom, E1 1BB
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
St. George's Hospital
London, United Kingdom, SW170QT
Imperial College Healthcare NHS Trust
London, United Kingdom, W2YN1
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Plymouth Hospitals NHS Trust
Plymouth, United Kingdom, PL6 8DH
Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom, PO6 3LY
Abertawe Bro Morgannwg University Health Board
Swansea, United Kingdom, SA2 8QA
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03053063     History of Changes
Other Study ID Numbers: GS-US-384-1944
2016-004148-13 ( EudraCT Number )
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases