Study 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.
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
STELLAR-3
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
2 other identifiers
interventional
808
26 countries
296
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2017
296 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2017
CompletedStudy Start
First participant enrolled
February 13, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2019
CompletedResults Posted
Study results publicly available
June 29, 2020
CompletedJune 29, 2020
June 1, 2020
2.3 years
February 10, 2017
June 10, 2020
June 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Week 48
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.
Week 240
Secondary Outcomes (6)
Percentage of Participants Who Had Progression to Cirrhosis at Week 48
Week 48
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240
Week 240
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48
Week 48
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240
Week 240
Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48
Week 48
- +1 more secondary outcomes
Study Arms (3)
SEL 18 mg
EXPERIMENTALRandomized 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.
SEL 6 mg
EXPERIMENTALRandomized 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.
Placebo
PLACEBO COMPARATORRandomized 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (298)
Institute of Liver Health
Chandler, Arizona, 85224, United States
Banner University Medical Center-Phoenix
Phoenix, Arizona, 85006, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of Arizona
Tucson, Arizona, 85724, United States
Baptist Medical Center
Little Rock, Arkansas, 72204, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72204, United States
eStudySite
Chula Vista, California, 91911, United States
Southern California Liver Centers
Coronado, California, 92673, United States
United Gastroenterologists
Costa Mesa, California, 92626, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
Fresno Clinical Research Center
Fresno, California, 93720, United States
University of California San Diego (UCSD)
La Jolla, California, 92103, United States
Ruane Clinical Research Group
Los Angeles, California, 90036, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
eStudySite
Oceanside, California, 92056, United States
California Liver Institute
Pasadena, California, 91105, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
University of California, Davis Medical Center
Sacramento, California, 95817, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, 92514, United States
California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
San Francisco, California, 94115, United States
Mission Gastroenterology and Hepatology
San Francisco, California, 94115, United States
University of California San Francisco (UCSF)
San Francisco, California, 94143, United States
Silicon Valley Research Institute
San Jose, California, 95128, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
Integrity Clinical Research, LLC
Doral, Florida, 33166, United States
UF Hepatology Research at CTRB
Gainesville, Florida, 32610, United States
UF Health Jacksonville-Gastroenterology Emerson
Jacksonville, Florida, 32207, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Sunrise Medical Research, Inc
Lauderdale Lakes, Florida, 33319, United States
Sunrise Research Institute
Miami, Florida, 33130, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136, United States
Genoma Research Group, Inc
Miami, Florida, 33165, United States
Advanced Research Institute
New Port Richey, Florida, 34653, United States
Avail Clinical Research, LLC
Orange City, Florida, 32763, United States
South Florida Center of Gastroenterology, PA
Wellington, Florida, 33414, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33540, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Piedmont Transplant Institute
Atlanta, Georgia, 30309, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Northwestern Memorial Hospital; Clinical Research Unit
Chicago, Illinois, 60611, United States
The University of Chicago Medical Center
Chicago, Illinois, 60615, United States
NorthShore University Healthsystem
Glenview, Illinois, 60026, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Gastroenterology Associates of Hazard
Hazard, Kentucky, 41707, United States
Delta Research Partners, LLC
Bastrop, Louisiana, 71021, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Ocshner Medical Center
New Orleans, Louisiana, 70121, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Digestive Disease Associates, PA
Catonsville, Maryland, 21228, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21472, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519, United States
Huron Gastroenterology Associates/Center for Digestive Care
Ypsilanti, Michigan, 48197, United States
University of Minnesota Medical Center - Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55095, United States
Southern Therapy and Advanced Research LLC (STAR)
Ridgeland, Mississippi, 39157, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Saint Louis University
St Louis, Missouri, 63104, United States
eStudySite
Las Vegas, Nevada, 89109, United States
Rutgers New Jersey Medical School- Doctors Office Center
Newark, New Jersey, 07102, United States
University of Buffalo, Clinical and Translational Research Center
Buffalo, New York, 14230, United States
Northwell Health - Sandra Atlas Bass Center for Liver Diseases
Manhasset, New York, 11030, United States
Icahn School of Medicine at Mount Sinai Beth Israel
New York, New York, 10003, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill / UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center - Duke South Clinics
Durham, North Carolina, 27710, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
Triad Clinical Trials LLC
Greensboro, North Carolina, 27410, United States
Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
Huntersville, North Carolina, 28078, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, 27804, United States
Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
Statesville, North Carolina, 28625, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45249, United States
UC Health/Holmes Hospital
Cincinnati, Ohio, 45267, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017, United States
Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
Pittsburgh, Pennsylvania, 15213, United States
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
eStudySite
Pittsburgh, Pennsylvania, 15251, United States
Guthrie Medical Group, PC
Sayre, Pennsylvania, 18840, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29245, United States
Greenville Health System - Gastroenterology and Liver Center
Greenville, South Carolina, 29605, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Gastro One
Germantown, Tennessee, 38138, United States
Quality Medical Research PLLC
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center - Digestive Disease Center
Nashville, Tennessee, 37212, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Pinnacle Clinical Research, PLLC
Austin, Texas, 78746, United States
Austin Center for Clinical Research
Austin, Texas, 78756, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Texas Digestive Disease Consultants
Dallas, Texas, 75246, United States
Baylor Scott & White All Saints Medical Center
Fort Worth, Texas, 76104, United States
Kelsey-Seybold Clinic
Houston, Texas, 77025, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030, United States
VAMC & Baylor College
Houston, Texas, 77030, United States
Pinnacle Clinical Research, PLLC
Live Oak, Texas, 78233, United States
American Research Corporation, The Texas Liver Institute
San Antonio, Texas, 78215, United States
Intermountain Liver Disease and Transplant Center
Murray, Utah, 84107, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
The University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Verity Research, Inc.
Fairfax, Virginia, 22031, United States
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Emeritas Research Group
Lansdowne Town Center, Virginia, 20716, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Newport News, Virginia, 23602, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Richmond, Virginia, 23226, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Virginia Mason
Seattle, Washington, 98101, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
Hospital Italiano de Buenos Aires
Buenos Aires, 450, Argentina
Instituto Oulton
Córdoba, X5000JJS, Argentina
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
St. George's Hospital
Kogarah, New South Wales, 2217, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Health, Monash Medical Centre
Clayton, Victoria, 3168, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
The Alfred Hospital, Alfred Health
Melbourne, Victoria, 3004, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
Graz, A-8036, Austria
Allgemeines Krankenhaus Wien
Vienna, 1090, Austria
CUB Hopital Erasme
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP
Botucatu, 18618-000, Brazil
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Porto Alegre, CEP 90035-903, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, 14048-900, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo
São Paulo, 01246-903, Brazil
Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)
São Paulo, 04040-003, Brazil
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)
Edmonton, Alberta, T6G 2X8, Canada
LAIR Centre
Vancouver, British Columbia, V5Z 1H2, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8T 5G4, Canada
South Shore Medical Arts
Bridgewater, Nova Scotia, B4V 3N2, Canada
William Osler Health System-Brampton Civic Hospital
Brampton, Ontario, Canada
South Shore Medical Arts
London, Ontario, N6A 5A5, Canada
Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3JI, Canada
Centre Hospitalier Universitaire d'Angers
Angers, 49033, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, 63003, France
Hopital Henri Mondor
Créteil, 94010, France
CHU de Grenoble- Hopital Michallon
Grenoble, 38043, France
Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
Lille, 59000, France
CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
Limoges, 87000, France
Hopital de la Croix Rousse
Lyon, 69317, France
Hôpital Saint Joseph
Marseille, 13008, France
Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
Nice, 06200, France
Hopital Cochin
Paris, 75014, France
Hopital Beaujon
Pessac, 33600, France
Centre Hospitalier Universitaire de Bordeaux
Pessac, 33604, France
Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
Strasbourg, 67091, France
Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
Toulouse, 31059, France
Hopital Paul Brousse
Villejuif, 94800, France
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, 52074, Germany
Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)
Berlin, 13353, Germany
Universitatsklinikum Bonn (AoR)
Bonn, 53105, Germany
Universitatsklinikum Frankfurt der Goethe-Universitat
Frankfurt, 60590, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Uniklinikum des Saarlandes- Klinik fur Innere Medizin II
Homburg, 66421, Germany
Gastroenterologisch- Hepatologisches Zentrum Kiel
Kiel, 24146, Germany
Eugastro Gmbh
Leipzig, 04103, Germany
Johannes Gutenberg-Universitat
Mainz, 55131, Germany
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Tuen Mun Hospital
Tuenmen, Hong Kong
Midas Multispecialty Hospital
Nagpur, Maharashtra, 440010, India
Institute of Post Graduate Medical Education and Research / SSKM Hospital
Kolkata, 700020, India
Kasturba Medical College (KMC) Hospital
Mangalore, 575001, India
Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)
Mumbai, 400012, India
Maharaja Agrasen Hospital
New Delhi, 110026, India
All India Institute of Medical Sciences
New Delhi, 110029, India
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, 110070, India
Institute of Liver & Biliary Sciences
New Delhi, 110070, India
Rambam Health Care Campus
Haifa, 30196, Israel
The Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Holy Family hospital
Nazareth, 91008, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa, 56124, Italy
IRCCS Ospedale Casa Sollievo Della Soferrenza
San Giovanni Rotondo, 71013, Italy
Chiba University Hospital
Chiba, 260-8670, Japan
Fukui-Ken Saiseikai Hospital
Fukui-shi, 918-8503, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
Hiroshima University Hospital
Hiroshima, 734-8551, Japan
Tokyo Medical University Ibaraki Medical Center
Ibaraki, 300-0395, Japan
Juntendo University Shizuoka Hospital
Izunokuni, 410-2295, Japan
Kagoshima University Medical And Dental Hospital
Kagoshima, 890-8520, Japan
Kanazawa University Hospital
Kanagawa, 920-8641, Japan
Nara Medical University Hospital
Kashihara, 634-8522, Japan
Toranomon Hospital Kajigaya
Kawasaki, 105-8470, Japan
Shinkokura Hospital
Kitakyushu, 803-8505, Japan
Kumamoto Shinto General Hospital
Kumamoto, 862-8655, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Shinshu University Hospital
Matsumoto, 390-8621, Japan
Toranomon Hospital
Minato, 105-8470, Japan
Miyazaki Medical Center Hospital
Miyazaki, 880-0003, Japan
Japanese Red Cross Musashino Hospital
Musashino, 180-8610, Japan
Aichi Medical University Hospital
Nagakute, 480-1195, Japan
Heart Life Hospital
Nakagami, 901-2492, Japan
Nara City Hospital
Nara, 630-8305, Japan
Hyogo College of Medicine Hospital
Nishinomiya, 663-8501, Japan
Kawasaki Medical School General Medical Center
Okayama, 700-808, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, 856-8562, Japan
Hirakata Kohsai Hospital
Ōsaka, 573-0153, Japan
Saga University Hospital
Saga, 849-8501, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 600-0033, Japan
Tohoku Rosai Hospital
Sendai, 981-8563, Japan
National Center for Global Health and Medicine Hospital
Shinjuku-ku, 162-8655, Japan
Saiseikai Suita Hospital
Suita, 564-0013, Japan
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557, Japan
Ehime University Hospital
Tōno, 7190295, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Yokohama City University Hospital
Yokohama, 236-0004, Japan
Hospital Selayang
Batu Caves, 68100, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, 50603, Malaysia
Phylasis Clinicas Research S. de RL de CV.
Cuautitlán, 54769, Mexico
Consultorio Médico
Mexico City, 6700, Mexico
Investigaciones Medicas Cisneros SC
Monterrey, 64000, Mexico
University Medical Center Utrecht
Utrecht, 3508 GA, Netherlands
Auckland City Hospital
Grafton, 1023, New Zealand
Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
Bytom, 41-902, Poland
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
Lodz, 91-347, Poland
Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E
Vila Real, 5000, Portugal
Klinical Investigations Group, LLC
San Juan, 00907, Puerto Rico
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169856, Singapore
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Changi General Hospital Pte Ltd.
Singapore, 529889, Singapore
Khoo Teck Puat Hospital
Singapore, 768828, Singapore
Keimyung University Dongsan Medical Center
Daegu, 41931, South Korea
Kyungpook National University Hospital
Daegu, 700-721, South Korea
National Health Insurance Service- Ilsan Hospital
Goyang-si, 10444, South Korea
Hanyang University Seoul Hospital
Seoul, 04763, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 120-752, South Korea
Gangnam Severance Hospital
Seoul, 135-720, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
SMG-SNU Boramae Medical Center
Seoul, 37061, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 26426, South Korea
Hospital del Mar
Barcelona, 08003, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Puerto de Hierro Majadahonda
Majadahonda, 28220, Spain
CHOP_Complejo Hospitalrio Universitario de Pontevedra
Pontevedra, 36071, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
Bern, 3010, Switzerland
Istituto Cantonale di Patologia Locarno
Lugano, 6900, Switzerland
Changhua Christian Hospital
Chang-hua, 500, Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Chiayi City, 60002, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80099, Taiwan
E-DA Hospital
Kaohsiung City, 82445, Taiwan
Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital
Keelung, 20401, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospitalv
Tainan, 7428, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Cathay General Hospital
Taipei, 10630, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital
Taoyuan District, 33305, Taiwan
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Derby Teaching Hospitals NHS FT
Derby, DE22 3NE, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Edgbaston, B15 2TH, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Imperial College Healthcare NHS Trust
London, W21NY, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE2 3HH, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, NR4 7UY, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, PO6 3LY, United Kingdom
Abertawe Bro Morgannwg University Health Board
Swansea, SA2 8QA, United Kingdom
Related Publications (11)
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.
PMID: 31271665RESULTAlkhouri 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.
RESULTYounossi 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.
PMID: 30779990RESULTAnstee 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.
RESULTYounossi 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.
RESULTYounossi 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.
RESULTYounossi 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.
RESULTLoomba R, Huang DQ, Sanyal AJ, Anstee QM, Trauner M, Lawitz EJ, Ding D, Ma L, Jia C, Billin A, Huss RS, Chung C, Goodman Z, Wong VW, Okanoue T, Romero-Gomez M, Abdelmalek MF, Muir A, Afdhal N, Bosch J, Harrison S, Younossi ZM, Myers RP. Liver stiffness thresholds to predict disease progression and clinical outcomes in bridging fibrosis and cirrhosis. Gut. 2023 Mar;72(3):581-589. doi: 10.1136/gutjnl-2022-327777. Epub 2022 Sep 9.
PMID: 36750244DERIVEDYounossi 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.
PMID: 33307033DERIVEDHarrison 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; 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.
PMID: 32147362DERIVEDYounossi 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.
PMID: 30639779DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Based on the results of the Week 48 analysis, the study was terminated early for lack of efficacy as prespecified in the clinical study protocol.
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 14, 2017
Study Start
February 13, 2017
Primary Completion
June 19, 2019
Study Completion
June 19, 2019
Last Updated
June 29, 2020
Results First Posted
June 29, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share