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

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SEL
Placebo to match SEL 6 mg
Placebo to match SEL 18 mg
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute of Liver Health
  • St. Joseph's Hospital and Medical Center
  • Mayo Clinic
  • Baptist Medical Center
  • Arkansas Gastroenterology
  • Southern California Research Center
  • Fresno Clinical Research Center
  • Scripps Clinical Research Services
  • University of California, San Diego (Altman Clinical and Translational Research Center)
  • Ruane Clinical Research Group
  • Cedars-Sinai Medical Center
  • Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center
  • California Liver Research Institute
  • Huntington Medical Research Institutes (HMRI) Liver Center
  • Inland Empire Liver Foundation
  • University of California, Davis Medical Center
  • Research and Education, Inc.
  • Medical Associates Research Group
  • Kaiser Permanente
  • California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
  • eStudySite
  • University of California, San Francisco-Liver Clinic
  • Island View Gastroenterology Associates- Ventura
  • University of Colorado Denver and Hospital
  • South Denver Gastroenterology, PC
  • Integrity Clinical Research, LLC
  • University of Florida Hepatology Research at CTRB
  • Clinical Research of Homestead
  • Nature Coast Clinical Research
  • Florida Research Institute
  • Schiff Center for Liver Diseases/University of Miami
  • Florida Hospital Transplant Institute
  • IMIC Inc
  • South Florida Center of Gastroenterology, PA
  • Cleveland Clinic Florida
  • Florida Medical Clinic, PA
  • Digestive Healthcare of Georgia
  • Piedmont Transplant Institute
  • Columbus Regional Research Institute
  • Gastroenterology Associates of Central Georgia, LLC
  • Gastrointestinal Specialists of Georgia, PC
  • Northwestern Memorial Hospital; Clinical Research Unit
  • Rush University Medical Center
  • The University of Chicago Medical Center
  • NorthShore University HealthSystem - Glenbrook ACC
  • Indiana University Health - University Hospital
  • Indianapolis Gastroenterology Research Foundation
  • Iowa Digestive Disease Center, P.C.
  • University of Kansas Medical Center
  • Gastroenterology Associates of Hazard
  • University of Louisville Clinical Trials Unit
  • Delta Research Partners
  • Tulane University Health Sciences Center
  • Ocshner Medical Center
  • Louisiana Research Center, LLC
  • Mercy Medical Center
  • Walter Reed National Military Medical Center
  • Digestive Disease Associates, PA
  • Meritus Center for Clinical Research
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts Medical School
  • Henry Ford Health System
  • Gastroenterology Associates of Western Michigan, P.L.C.
  • Mayo Clinic
  • Southern Therapy and Advanced Research LLC (STAR)
  • Saint Luke's Hospital of Kansas City
  • Kansas City Research Institute
  • Saint Louis University
  • Rutgers New Jersey Medical School- Doctors Office Center
  • AccumetRx Clinical Research
  • Montefiore Medical Center
  • University of Buffalo, Clinical and Translational Research Center
  • Northwell Health - Sandra Atlas Bass Center for Liver Diseases
  • Icahn School of Medicine at Mount Sinai Beth Israel
  • NYU Langone Medical Center
  • Weill Cornell Medical College
  • Icahn School of Medicine at Mount Sinai
  • University of Rochester Medical Center
  • NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill
  • Carolinas HealthCare System Center for Liver Disease
  • Duke University Medical Center - Duke South Clinics
  • Cumberland Research Associates LLC
  • Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
  • PMG Research of Rocky Mount, LLC
  • Piedmont Healthcare
  • Digestive Health Specialists, PA
  • Consultants for Clinical Research
  • University of Cincinnati
  • University Hospitals Cleveland Medical Center
  • Penn State University, The Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
  • Thomas Jefferson University Hospital
  • UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
  • University Gastroenterology
  • Medical University of South Carolina, University Hospital
  • Greenville Health System Gastroenterology and Liver Center
  • WR-ClinSearch, LLC
  • Gastro One
  • Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research
  • Quality Medical Research PLLC
  • Vanderbilt University Medical Center - Digestive Disease Center
  • Texas Clinical Research Institute, LLC
  • Pinnacle Clinical Research, PLLC
  • Austin Center for Clinical Research
  • The Liver Institute at Methodist Dallas Medical Center
  • Texas Digestive Disease Consultants
  • Kelsey-Seybold Clinic
  • Baylor College of Medicine - Advanced Liver Therapies
  • Houston Methodist Hospital
  • Liver Associates of Texas, P.A.
  • Research Specialists of Texas
  • Smith Clinic
  • Pinnacle Clinical Research
  • DHAT Research Institute
  • American Research Corporation, The Texas Liver Institute
  • Intermountain Liver Disease and Transplant Clinic
  • University of Utah
  • The University of Vermont Medical Center
  • University of Virginia Medical Center
  • Inova Fairfax Medical Campus
  • Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
  • Digestive and Liver Disease Specialists
  • McGuire VA Medical Center
  • Virginia Commonwealth University
  • Virginia Mason
  • Swedish Organ Transplant and Liver Center
  • University of Washington
  • Royal Prince Alfred Hospital
  • St. Vincent's Hospital Sydney
  • St. George's Hospital
  • Westmead Hospital
  • Royal Brisbane & Women's Hospital
  • Royal Adelaide Hospital
  • Lyell McEwin Hospital
  • Monash Medical Centre
  • St. Vincent's Hospital Melbourne
  • Austin Health
  • The Alfred Hospital, Alfred Health
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
  • Allgemeines Krankenhaus Wien
  • UZ Brussel
  • Cliniques Universitaires UCL Saint-Luc
  • CUB Hopital Erasme
  • Az Maria Middelares Ghent
  • UZ Leuven
  • University of Calgary Liver Unit (Heritage Medical Research Clinic)
  • GI Research
  • University of Alberta
  • LAIR Centre
  • Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
  • PerCuro Clinical Research Ltd.
  • University of Manitoba, Health Sciences Centre, John Buhler Research Centre
  • South Shore Medical Arts
  • William Osler Health System-Brampton Civic Hospital
  • St. Joseph's Healthcare Hamilton
  • McMaster University Medical Centre
  • London Health Sciences Centre - University Hospital
  • Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
  • Toronto Liver Centre
  • Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
  • CHU Amiens Picardie
  • Centre Hospitalier Universitaire d'Angers
  • Centre Hospitalier Universitaire Estaing
  • Hopital Henri Mondor
  • CHU de Grenoble- Hopital Michallon
  • Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
  • CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
  • Hopital de la Croix Rousse
  • Hôpital Saint Joseph
  • CHU de Montpellier, Hopital St Eloi
  • Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
  • Hopital Cochin
  • Groupe Hospitalier Universitaire La Pitie Salpetriere
  • Hopital Beaujon
  • Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
  • Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
  • Uniklinik RWTH Aachen, Medizinische Klinik III
  • Universitatsklinikum Bonn (AoR)
  • Universitatsklinikum Frankfurt der Goethe-Universitat
  • Universitatsklinikum Leipzig AoR
  • Johannes Gutenberg-Universitat
  • Prince of Wales Hospital
  • Alice Ho Miu Ling Nethersole Hospital
  • Department of Hepatology PGIMER Chandigarh
  • Global Clinical Reseaech Services PVT LTD
  • Institute of Post Graduate Medical Education and Research (IPGMER)
  • Dayanand Medical College & Hospital
  • Kasturba Medical College Hospital
  • Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals
  • Midas Multispecialty Hospital
  • All India Institute of Medical Sciences
  • Fortis Flt. Lt. Rajan Dhall Hospital
  • Institute of Liver & Biliary Sciences
  • Emek Medical Center
  • Rambam Health Care Campus
  • The Lady Davis Carmel Medical Center
  • Shaare Zedek Medical Center
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Tel-Aviv Sourasky Medical Center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • IRCCS Istituto Clinico Humanitas
  • Fukui-Ken Saiseikai Hospital
  • Kyushu University Hospital
  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
  • Juntendo University Shizuoka Hospital
  • Kanazawa University Hospital
  • Nara Medical University Hospital
  • Toranomon Hospital Kajigaya
  • Kumamoto Shinto General Hospital
  • Kurume University Hospital
  • University Hospital, Kyoto Prefectural University of Medicine
  • Shinshu University Hospital
  • Toranomon Hospital
  • Miyazaki Medical Center Hospital
  • Aichi Medical University Hospital
  • Nara City Hospital
  • Kawasaki Medical School General Medical Center
  • Okayama University Hospital
  • Hirakata Kohsai Hospital
  • Saga University Hospital
  • Hokkaido University Hospital
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  • Tokyo Womens Medical University Hospital
  • Saiseikai Suita Hospital
  • Osaka University Hospital
  • Mie University Hospital
  • Ehime University Hospital
  • Yamagata University Hospital
  • Yokohama City University Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • National Health Insurance Service- Ilsan Hospital
  • Inha University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Asan Medical Center
  • SMG-SNU Boramae Medical Center
  • Gangnam Severance Hospital
  • Korea University Guro Hospital
  • Consultorio Médico
  • Accelerium S. de R.L. de C.V.
  • Auckland City Hospital
  • Southern District Health Board - Dunedin Hospital
  • Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
  • ID Clinic Arkadiusz Pisula
  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
  • Klinical Investigations Group, LLC
  • VA Carribean Healthcare System
  • Fundacion de Investigacion de Diego
  • National University Health System
  • Singapore General Hospital
  • Changi General Hospital Pte Ltd.
  • Hospital Universitario Fundacion Alcorcon
  • Hospital Universitari Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital del Mar - Parc de Salut
  • Hospital Universitario La Paz
  • Hospital Universitario Puerto de Hierro Majadahonda
  • CHOP_Complejo Hospitalario Universitario de Pntevedra
  • Hospital Universitario Marques de Valdecilla
  • Hospital Universitario Virgen del Rocio
  • Consorcio Hospital General Universitario de Valencia
  • Hospital Universitari i Politecnic La Fe de Valencia
  • Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
  • Istituto Cantanale di Patologia Locarno
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital
  • Chang Gung Medical Foundation-LinKou Branch
  • NHS Greater Glasgow and Clyde
  • Barts Health NHS Trust
  • King's College Hospital NHS Foundation Trust
  • St. George's Hospital
  • Imperial College Healthcare NHS Trust
  • Nottingham University Hospitals NHS Trust
  • Plymouth Hospitals NHS Trust
  • Portsmouth Hospitals NHS Trust
  • Abertawe Bro Morgannwg University Health Board

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

SEL 6 mg

SEL 18 mg

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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.
Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event
EFS was assessed by the time to the first clinical event, including liver decompensation events, liver transplantation and all-cause mortality.

Secondary Outcome Measures

Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at 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.
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at 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).
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at 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).
Percentage of Participants Who Had NASH Resolution at 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.
Percentage of Participants Who Had NASH Resolution at 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.

Full Information

First Posted
February 10, 2017
Last Updated
April 24, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03053063
Brief Title
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Acronym
STELLAR-4
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to lack of efficacy based on the results of the Week 48 analysis as prespecified in the clinical study protocol.
Study Start Date
January 30, 2017 (Actual)
Primary Completion Date
May 6, 2019 (Actual)
Study Completion Date
May 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
883 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEL 6 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
SEL 18 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SEL
Other Intervention Name(s)
selonsertib, GS-4997
Intervention Description
Tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match SEL 6 mg
Intervention Description
Tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match SEL 18 mg
Intervention Description
Tablets administered orally once daily
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Week 48
Title
Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event
Description
EFS was assessed by the time to the first clinical event, including liver decompensation events, liver transplantation and all-cause mortality.
Time Frame
Week 240
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240
Description
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.
Time Frame
Week 240
Title
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48
Description
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).
Time Frame
Week 48
Title
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240
Description
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).
Time Frame
Week 240
Title
Percentage of Participants Who Had NASH Resolution at Week 48
Description
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.
Time Frame
Week 48
Title
Percentage of Participants Who Had NASH Resolution at Week 240
Description
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.
Time Frame
Week 240

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Citations:
PubMed Identifier
31271665
Citation
Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.
Results Reference
result
Citation
Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.
Results Reference
result
PubMed Identifier
30779990
Citation
Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.
Results Reference
result
Citation
Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.
Results Reference
result
Citation
Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.
Results Reference
result
Citation
Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.
Results Reference
result
Citation
Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.
Results Reference
result
PubMed Identifier
32147362
Citation
Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3 and STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.
Results Reference
result
PubMed Identifier
33307033
Citation
Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.
Results Reference
derived
PubMed Identifier
30639779
Citation
Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.
Results Reference
derived

Learn more about this trial

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

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