Back to resultsSafety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis (STELLAR-3)
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
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis
Eligibility Criteria
Key Inclusion Criteria:
- Liver biopsy consistent with NASH and bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader
Has the following laboratory parameters at the screening visit:
- Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
- Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
- Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
- Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)
Key Exclusion Criteria:
- Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
- Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic anti-coagulation
- Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
- Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology.
- History of liver transplantation
- Current or history of hepatocellular carcinoma (HCC)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Institute of Liver Health
- Banner University Medical Center-Phoenix
- St. Joseph's Hospital and Medical Center
- Mayo Clinic
- University of Arizona
- Baptist Medical Center
- Arkansas Gastroenterology
- eStudySite
- Southern California Liver Centers
- United Gastroenterologists
- TriWest Research Associates, LLC
- Fresno Clinical Research Center
- University of California San Diego (UCSD)
- Ruane Clinical Research Group
- Cedars Sinai Medical Center
- VA Greater Los Angeles Healthcare System
- eStudySite
- California Liver Institute
- Inland Empire Liver Foundation
- University of California, Davis Medical Center
- Medical Associates Research Group
- Kaiser Permanente
- California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
- Mission Gastroenterology and Hepatology
- University of California San Francisco (UCSF)
- Silicon Valley Research Institute
- University of Colorado
- Yale University School of Medicine
- Integrity Clinical Research, LLC
- UF Hepatology Research at CTRB
- UF Health Jacksonville-Gastroenterology Emerson
- Florida Research Institute
- Sunrise Medical Research, Inc
- Sunrise Research Institute
- Schiff Center for Liver Diseases/University of Miami
- Genoma Research Group, Inc
- Advanced Research Institute
- Avail Clinical Research, LLC
- South Florida Center of Gastroenterology, PA
- Florida Medical Clinic, PA
- Digestive Healthcare of Georgia
- Piedmont Transplant Institute
- Gastrointestinal Specialists of Georgia, PC
- Northwestern Memorial Hospital; Clinical Research Unit
- The University of Chicago Medical Center
- NorthShore University Healthsystem
- Indiana University Health - University Hospital
- Indianapolis Gastroenterology Research Foundation
- University of Iowa Hospitals and Clinics
- University of Kansas Medical Center
- Gastroenterology Associates of Hazard
- Delta Research Partners, LLC
- 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
- Henry Ford Health System
- Gastroenterology Associates of Western Michigan, P.L.C.
- Huron Gastroenterology Associates/Center for Digestive Care
- University of Minnesota Medical Center - Fairview
- Mayo Clinic
- Southern Therapy and Advanced Research LLC (STAR)
- Saint Luke's Hospital of Kansas City
- Kansas City Gastroenterology and Hepatology
- Saint Louis University
- eStudySite
- Rutgers New Jersey Medical School- Doctors Office 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
- University of Rochester Medical Center
- University of North Carolina at Chapel Hill / UNC School of Medicine
- Duke University Medical Center - Duke South Clinics
- Cumberland Research Associates, LLC
- Triad Clinical Trials LLC
- Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
- PMG Research of Rocky Mount, LLC
- Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
- Digestive Health Specialists, PA
- Consultants for Clinical Research
- UC Health/Holmes Hospital
- Northeast Clinical Research Center, LLC
- Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
- Thomas Jefferson University
- UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
- VA Pittsburgh Healthcare System
- eStudySite
- Guthrie Medical Group, PC
- University Gastroenterology
- Medical University of South Carolina
- Greenville Health System - Gastroenterology and Liver Center
- WR-ClinSearch, LLC
- Gastro One
- 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
- Baylor Scott & White All Saints Medical Center
- Kelsey-Seybold Clinic
- Baylor College of Medicine - Advanced Liver Therapies
- VAMC & Baylor College
- Pinnacle Clinical Research, PLLC
- American Research Corporation, The Texas Liver Institute
- Intermountain Liver Disease and Transplant Center
- University of Utah Hospital
- The University of Vermont Medical Center
- University of Virginia Medical Center
- Verity Research, Inc.
- Inova Fairfax Medical Campus
- Emeritas Research Group
- Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
- Digestive and Liver Disease Specialists
- Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
- McGuire VA Medical Center
- Virginia Commonwealth University
- Virginia Mason
- Swedish Organ Transplant and Liver Center
- Froedtert Memorial Lutheran Hospital
- Hospital Italiano de Buenos Aires
- Instituto Oulton
- St. Vincent's Hospital Sydney
- St. George's Hospital
- Westmead Hospital
- Royal Brisbane & Women's Hospital
- Royal Adelaide Hospital
- Monash Health, Monash Medical Centre
- St. Vincent's Hospital Melbourne
- Austin Hospital
- The Alfred Hospital, Alfred Health
- Royal Perth Hospital
- Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
- Allgemeines Krankenhaus Wien
- CUB Hopital Erasme
- UZ Brussel
- Universitaire Ziekenhuizen Leuven
- Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
- Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
- Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo
- Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)
- University of Calgary Liver Unit (Heritage Medical Research Clinic)
- University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
- LAIR Centre
- Gordon and Leslie Diamond Health Care Centre
- (G.I.R.I.) GI Research Institute
- PerCuro Clinical Research Ltd.
- South Shore Medical Arts
- William Osler Health System-Brampton Civic Hospital
- South Shore Medical Arts
- Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
- Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
- 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
- Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
- Hopital Cochin
- Hopital Beaujon
- Centre Hospitalier Universitaire de Bordeaux
- Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
- Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
- Hopital Paul Brousse
- Uniklinik RWTH Aachen, Medizinische Klinik III
- Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
- Universitatsklinikum Bonn (AoR)
- Universitatsklinikum Frankfurt der Goethe-Universitat
- Medizinische Hochschule Hannover
- Uniklinikum des Saarlandes- Klinik fur Innere Medizin II
- Gastroenterologisch- Hepatologisches Zentrum Kiel
- Eugastro Gmbh
- Johannes Gutenberg-Universitat
- Alice Ho Miu Ling Nethersole Hospital
- Tuen Mun Hospital
- Midas Multispecialty Hospital
- Institute of Post Graduate Medical Education and Research / SSKM Hospital
- Kasturba Medical College (KMC) Hospital
- Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)
- Maharaja Agrasen Hospital
- All India Institute of Medical Sciences
- Fortis Flt. Lt. Rajan Dhall Hospital
- Institute of Liver & Biliary Sciences
- Rambam Health Care Campus
- The Lady Davis Carmel Medical Center
- Holy Family hospital
- The Chaim Sheba Medical Center
- Tel-Aviv Sourasky Medical Center
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Azienda Ospedaliera Universitaria Pisana
- IRCCS Ospedale Casa Sollievo Della Soferrenza
- Chiba University Hospital
- Fukui-Ken Saiseikai Hospital
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
- Hiroshima University Hospital
- Tokyo Medical University Ibaraki Medical Center
- Juntendo University Shizuoka Hospital
- Kagoshima University Medical And Dental Hospital
- Kanazawa University Hospital
- Nara Medical University Hospital
- Toranomon Hospital Kajigaya
- Shinkokura Hospital
- Kumamoto Shinto General Hospital
- Kurume University Hospital
- University Hospital, Kyoto Prefectural University of Medicine
- Shinshu University Hospital
- Toranomon Hospital
- Miyazaki Medical Center Hospital
- Japanese Red Cross Musashino Hospital
- Aichi Medical University Hospital
- Heart Life Hospital
- Nara City Hospital
- Hyogo College of Medicine Hospital
- Kawasaki Medical School General Medical Center
- Okayama University Hospital
- National Hospital Organization Osaka National Hospital
- Saga University Hospital
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
- Tohoku Rosai Hospital
- National Center for Global Health and Medicine Hospital
- Saiseikai Suita Hospital
- Kagawa Prefectural Central Hospital
- Mie University Hospital
- Ehime University Hospital
- Yamagata University Hospital
- Yokohama City University Hospital
- National Hospital Organization Nagasaki Medical Center
- Hirakata Kohsai Hospital
- Keimyung University Dongsan Medical Center
- Kyungpook National University Hospital
- National Health Insurance Service- Ilsan Hospital
- Hanyang University Seoul Hospital
- Asan Medical Center
- Chung-Ang University Hospital
- Severance Hospital, Yonsei University Health System
- Gangnam Severance Hospital
- Korea University Guro Hospital
- SMG-SNU Boramae Medical Center
- Yonsei University Wonju Severance Christian Hospital
- Hospital Selayang
- University of Malaya Medical Centre
- Phylasis Clinicas Research S. de RL de CV.
- Consultorio Médico
- Investigaciones Medicas Cisneros SC
- University Medical Center Utrecht
- Auckland City Hospital
- Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
- Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
- Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E
- Klinical Investigations Group, LLC
- VA Caribbean Healthcare System
- Fundacion de Investigacion de Diego
- National University Hospital
- Singapore General Hospital
- Tan Tock Seng Hospital
- Changi General Hospital Pte Ltd.
- Khoo Teck Puat Hospital
- Hospital del Mar
- Hospital Universitari Vall d'Hebron
- Hospital Clinic de Barcelona
- Hospital Universitario La Paz
- Hospital Puerto de Hierro Majadahonda
- CHOP_Complejo Hospitalrio Universitario de Pontevedra
- Hospital Universitario Marques de Valdecilla
- Hospital Universitario Virgen del Rocio
- Hospital Universitari i Politecnic La Fe de Valencia
- Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
- Istituto Cantonale di Patologia Locarno
- Changhua Christian Hospital
- Ditmanson Medical Foundation Chia-Yi Christian Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- E-DA Hospital
- Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital
- Taichung Veterans General Hospital
- National Cheng Kung University Hospitalv
- National Taiwan University Hospital
- Mackay Memorial Hospital
- Cathay General Hospital
- Taipei Veterans General Hospital
- Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
- Cambridge University Hospitals NHS Foundation Trust
- Derby Teaching Hospitals NHS FT
- University Hospitals Birmingham NHS Foundation Trust
- King's College Hospital NHS Foundation Trust
- Imperial College Healthcare NHS Trust
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Nottingham University 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 18 mg
SEL 6 mg
Placebo
Arm Description
Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48
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 progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.
Secondary Outcome Measures
Percentage of Participants Who Had Progression to Cirrhosis at Week 48
Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from < 4 at baseline to 4 at Week 48.
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 Without Worsening of Fibrosis at Week 48
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03053050
Brief Title
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Acronym
STELLAR-3
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 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
February 13, 2017 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
June 19, 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 progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.
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
808 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEL 18 mg
Arm Type
Experimental
Arm Description
Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks
Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Arm Title
SEL 6 mg
Arm Type
Experimental
Arm Description
Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks
OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks
OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
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 Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48
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 progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.
Time Frame
Week 240
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Had Progression to Cirrhosis at Week 48
Description
Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from < 4 at baseline to 4 at Week 48.
Time Frame
Week 48
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 Without Worsening of Fibrosis at Week 48
Description
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
Time Frame
Week 48
Title
Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240
Description
NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
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 bridging (F3 fibrosis) according to the NASH Clinical Research Network (CRN) classification in the opinion of the central reader
Has the following laboratory parameters at the screening visit:
Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
Hemoglobin A1c (HbA1c) ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
Total bilirubin ≤ 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)
Key Exclusion Criteria:
Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic anti-coagulation
Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology.
History of liver transplantation
Current or history of hepatocellular carcinoma (HCC)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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
Banner University Medical Center-Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
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
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
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
72204
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Southern California Liver Centers
City
Coronado
State/Province
California
ZIP/Postal Code
92673
Country
United States
Facility Name
United Gastroenterologists
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
TriWest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Fresno Clinical Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
University of California San Diego (UCSD)
City
La Jolla
State/Province
California
ZIP/Postal Code
92103
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
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
eStudySite
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
California Liver Institute
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
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
Mission Gastroenterology and Hepatology
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Silicon Valley Research Institute
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Integrity Clinical Research, LLC
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
UF Hepatology Research at CTRB
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
UF Health Jacksonville-Gastroenterology Emerson
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Sunrise Medical Research, Inc
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Sunrise Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33130
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
Genoma Research Group, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Avail Clinical Research, LLC
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
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
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
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
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60615
Country
United States
Facility Name
NorthShore University Healthsystem
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
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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
Delta Research Partners, LLC
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
21472
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
Huron Gastroenterology Associates/Center for Digestive Care
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
University of Minnesota Medical Center - Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55095
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 Gastroenterology and Hepatology
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
eStudySite
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
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
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
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina at Chapel Hill / UNC School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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
Triad Clinical Trials LLC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27410
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, d/b/a Carolinas Center for Liver Disease
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
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
UC Health/Holmes Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
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
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
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
eStudySite
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15251
Country
United States
Facility Name
Guthrie Medical Group, PC
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
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
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29245
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
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
37212
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
Baylor Scott & White All Saints Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
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
VAMC & Baylor College
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pinnacle Clinical Research, PLLC
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
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 Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Hospital
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
Verity Research, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Inova Fairfax Medical Campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Emeritas Research Group
City
Lansdowne Town Center
State/Province
Virginia
ZIP/Postal Code
20716
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
23602
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
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
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
450
Country
Argentina
Facility Name
Instituto Oulton
City
Córdoba
ZIP/Postal Code
X5000JJS
Country
Argentina
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
Monash Health, 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 Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
The Alfred Hospital, Alfred Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
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
CUB Hopital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
City
Botucatu
ZIP/Postal Code
18618-000
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
City
Porto Alegre
ZIP/Postal Code
CEP 90035-903
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
City
Ribeirão Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo
City
São Paulo
ZIP/Postal Code
01246-903
Country
Brazil
Facility Name
Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)
City
São Paulo
ZIP/Postal Code
04040-003
Country
Brazil
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
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
LAIR Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
Gordon and Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
(G.I.R.I.) GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
PerCuro Clinical Research Ltd.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G4
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
Country
Canada
Facility Name
South Shore Medical Arts
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
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
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
59000
Country
France
Facility Name
CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
City
Limoges
ZIP/Postal Code
87000
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
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
Hopital Beaujon
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Pessac
ZIP/Postal Code
33604
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
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Uniklinik RWTH Aachen, Medizinische Klinik III
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Bonn (AoR)
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Universitatsklinikum Frankfurt der Goethe-Universitat
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Uniklinikum des Saarlandes- Klinik fur Innere Medizin II
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Gastroenterologisch- Hepatologisches Zentrum Kiel
City
Kiel
ZIP/Postal Code
24146
Country
Germany
Facility Name
Eugastro Gmbh
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Johannes Gutenberg-Universitat
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
Tuen Mun
Country
Hong Kong
Facility Name
Midas Multispecialty Hospital
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Institute of Post Graduate Medical Education and Research / SSKM Hospital
City
Kolkata
ZIP/Postal Code
700020
Country
India
Facility Name
Kasturba Medical College (KMC) Hospital
City
Mangalore
ZIP/Postal Code
575001
Country
India
Facility Name
Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Maharaja Agrasen Hospital
City
New Delhi
ZIP/Postal Code
110026
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
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
30196
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Facility Name
Holy Family hospital
City
Nazaret
ZIP/Postal Code
91008
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
Azienda Ospedaliera Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Soferrenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8670
Country
Japan
Facility Name
Fukui-Ken Saiseikai Hospital
City
Fukui-shi
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Tokyo Medical University Ibaraki Medical Center
City
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Facility Name
Juntendo University Shizuoka Hospital
City
Izunokuni
ZIP/Postal Code
410-2295
Country
Japan
Facility Name
Kagoshima University Medical And Dental Hospital
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Kanazawa University Hospital
City
Kanagawa
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
Shinkokura Hospital
City
Kitakyushu
ZIP/Postal Code
803-8505
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
Japanese Red Cross Musashino Hospital
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Nagakute
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Heart Life Hospital
City
Nakagami
ZIP/Postal Code
901-2492
Country
Japan
Facility Name
Nara City Hospital
City
Nara
ZIP/Postal Code
630-8305
Country
Japan
Facility Name
Hyogo College of Medicine Hospital
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kawasaki Medical School General Medical Center
City
Okayama
ZIP/Postal Code
700-808
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
City
Sapporo
ZIP/Postal Code
600-0033
Country
Japan
Facility Name
Tohoku Rosai Hospital
City
Sendai
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
National Center for Global Health and Medicine Hospital
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Saiseikai Suita Hospital
City
Suita
ZIP/Postal Code
564-0013
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu
ZIP/Postal Code
760-8557
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
7190295
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
Hirakata Kohsai Hospital
City
Ōsaka
ZIP/Postal Code
573-0153
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
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
120-752
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
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
37061
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wŏnju
ZIP/Postal Code
26426
Country
Korea, Republic of
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
University of Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Phylasis Clinicas Research S. de RL de CV.
City
Cuautitlán
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Consultorio Médico
City
Mexico City
ZIP/Postal Code
6700
Country
Mexico
Facility Name
Investigaciones Medicas Cisneros SC
City
Monterrey
ZIP/Postal Code
64000
Country
Mexico
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1023
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
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
City
Łódź
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E
City
Vila Real
ZIP/Postal Code
5000
Country
Portugal
Facility Name
Klinical Investigations Group, LLC
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico
Facility Name
VA Caribbean 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 Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Changi General Hospital Pte Ltd.
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Khoo Teck Puat Hospital
City
Singapore
ZIP/Postal Code
768828
Country
Singapore
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
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 Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Puerto de Hierro Majadahonda
City
Majadahonda
ZIP/Postal Code
28220
Country
Spain
Facility Name
CHOP_Complejo Hospitalrio Universitario de Pontevedra
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
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 Cantonale di Patologia Locarno
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Changhua Christian Hospital
City
Chang-hua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Ditmanson Medical Foundation Chia-Yi Christian Hospital
City
Chiayi City
ZIP/Postal Code
60002
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80099
Country
Taiwan
Facility Name
E-DA Hospital
City
Kaohsiung
ZIP/Postal Code
82445
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital
City
Keelung
ZIP/Postal Code
20401
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
National Cheng Kung University Hospitalv
City
Tainan
ZIP/Postal Code
7428
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
10630
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Derby Teaching Hospitals NHS FT
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Edgbaston
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W21NY
Country
United Kingdom
Facility Name
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City
Newcastle upon Tyne
ZIP/Postal Code
NE2 3HH
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospitals NHS Foundation Trust
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG7 2UH
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
No
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
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
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
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 Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
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