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 Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
STELLAR-4
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
2 other identifiers
interventional
883
21 countries
281
Brief Summary
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2017
281 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
Study Start
First participant enrolled
January 30, 2017
CompletedFirst Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2019
CompletedResults Posted
Study results publicly available
May 7, 2020
CompletedMay 7, 2020
April 1, 2020
2.3 years
February 10, 2017
April 24, 2020
April 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH
Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
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 liver decompensation events, liver transplantation and all-cause mortality.
Week 240
Secondary Outcomes (5)
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 at Week 48
Week 48
Percentage of Participants Who Had NASH Resolution at Week 240
Week 240
Study Arms (3)
SEL 6 mg
EXPERIMENTALRandomized Phase: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
SEL 18 mg
EXPERIMENTALRandomized Phase: SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
Placebo
PLACEBO COMPARATORRandomized Phase: Placebo to match SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
Interventions
Eligibility Criteria
You may qualify if:
- Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
- Has the following laboratory parameters at the screening visit, as determined by the central laboratory:
- Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
- Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
- HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to be resulted)
- International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation
- Platelet count ≥ 100,000/μL
You may not qualify if:
- Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
- Child-Pugh (CP) score \> 7, as determined at screening, unless due to therapeutic anti-coagulation
- Model for End-stage Liver Disease (MELD) score \> 12, as determined at screening, unless due to therapeutic anti-coagulation
- Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology.
- History of liver transplantation
- Current or history of hepatocellular carcinoma (HCC)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (283)
Institute of Liver Health
Chandler, Arizona, 85224, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
Baptist Medical Center
Little Rock, Arkansas, 72204, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Southern California Research Center
Coronado, California, 92118, United States
Fresno Clinical Research Center
Fresno, California, 93720, United States
Scripps Clinical Research Services
La Jolla, California, 92037, United States
University of California, San Diego (Altman Clinical and Translational Research Center)
La Jolla, California, 92093, United States
Ruane Clinical Research Group
Los Angeles, California, 90036, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center
Los Angeles, California, 90073, United States
California Liver Research Institute
Pasadena, California, 91105, United States
Huntington Medical Research Institutes (HMRI) Liver Center
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
Research and Education, Inc.
San Diego, California, 92105, 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
eStudySite
San Francisco, California, 94115, United States
University of California, San Francisco-Liver Clinic
San Francisco, California, 94143, United States
Island View Gastroenterology Associates- Ventura
Ventura, California, 93003, United States
University of Colorado Denver and Hospital
Aurora, Colorado, 80045, United States
South Denver Gastroenterology, PC
Englewood, Colorado, 80113, United States
Integrity Clinical Research, LLC
Doral, Florida, 33166, United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, 32610, United States
Clinical Research of Homestead
Homestead, Florida, 33030, United States
Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136, United States
Florida Hospital Transplant Institute
Orlando, Florida, 32804, United States
IMIC Inc
Palmetto, Florida, 33157, United States
South Florida Center of Gastroenterology, PA
Wellington, Florida, 33414, United States
Cleveland Clinic Florida
Weston, Florida, 33331, 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
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Northwestern Memorial Hospital; Clinical Research Unit
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago Medical Center
Chicago, Illinois, 60615, United States
NorthShore University HealthSystem - Glenbrook ACC
Glenview, Illinois, 60026, United States
Indiana University Health - University Hospital
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
Iowa Digestive Disease Center, P.C.
Clive, Iowa, 50325, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Gastroenterology Associates of Hazard
Hazard, Kentucky, 41707, United States
University of Louisville Clinical Trials Unit
Louisville, Kentucky, 40202, United States
Delta Research Partners
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, 21742, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, 49519, United States
Mayo Clinic
Rochester, Minnesota, 55905, 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 Research Institute
Kansas City, Missouri, 64131, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Rutgers New Jersey Medical School- Doctors Office Center
Newark, New Jersey, 07102, United States
AccumetRx Clinical Research
Albuquerque, New Mexico, 87109, 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
NYU Langone Medical Center
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Carolinas HealthCare System Center for Liver Disease
Charlotte, North Carolina, 28204, 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
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
Statesville, North Carolina, 28677, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45249, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Penn State University, The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
Pittsburgh, Pennsylvania, 15213, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Medical University of South Carolina, University Hospital
Charleston, South Carolina, 29425, 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
Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research
Memphis, Tennessee, 38104, United States
Quality Medical Research PLLC
Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center - Digestive Disease Center
Nashville, Tennessee, 37232, 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
Kelsey-Seybold Clinic
Houston, Texas, 77025, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Liver Associates of Texas, P.A.
Houston, Texas, 77030, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
Smith Clinic
Houston, Texas, 77030, United States
Pinnacle Clinical Research
Live Oak, Texas, 78233, United States
DHAT Research Institute
Richardson, Texas, 75082, United States
American Research Corporation, The Texas Liver Institute
San Antonio, Texas, 78215, United States
Intermountain Liver Disease and Transplant Clinic
Murray, Utah, 84107, United States
University of Utah
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
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Newport News, Virginia, 23226, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, 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
University of Washington
Seattle, Washington, 98195, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
Austin Health
Heidelberg, Victoria, 3081, Australia
The Alfred Hospital, Alfred Health
Melbourne, Victoria, 3004, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, 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, 10070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires UCL Saint-Luc
Brussels, 1200, Belgium
Az Maria Middelares Ghent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
University of Calgary Liver Unit (Heritage Medical Research Clinic)
Calgary, Alberta, T2N 4Z6, Canada
GI Research
Edmonton, Alberta, T5H 4B9, Canada
University of Alberta
Edmonton, Alberta, T6G 2R3, Canada
LAIR Centre
Vancouver, British Columbia, V5Z 1HZ, Canada
Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
Vancouver, British Columbia, V5Z 1M9, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, V8T 5G4, Canada
University of Manitoba, Health Sciences Centre, John Buhler Research Centre
Winnipeg, Manitoba, R3E 3P4, Canada
South Shore Medical Arts
Bridgewater, Nova Scotia, B4V 3N2, Canada
William Osler Health System-Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
McMaster University Medical Centre
Hamilton, Ontario, L8S 4L8, Canada
London Health Sciences Centre - University Hospital
London, Ontario, N6A 5A5, Canada
Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Toronto Liver Centre
Toronto, Ontario, M6H 3M1, Canada
Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3JI, Canada
CHU Amiens Picardie
Amiens, 80054, France
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, 59037, France
CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
Limoges, 87042, France
Hopital de la Croix Rousse
Lyon, 69317, France
Hôpital Saint Joseph
Marseille, 13008, France
CHU de Montpellier, Hopital St Eloi
Montpellier, 34925, France
Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
Nice, 06200, France
Hopital Cochin
Paris, 75014, France
Groupe Hospitalier Universitaire La Pitie Salpetriere
Paris, 75651, France
Hopital Beaujon
Pessac, 33600, France
Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
Strasbourg, 67091, France
Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
Toulouse, 31059, France
Uniklinik RWTH Aachen, Medizinische Klinik III
Aachen, 52074, Germany
Universitatsklinikum Bonn (AoR)
Bonn, 53105, Germany
Universitatsklinikum Frankfurt der Goethe-Universitat
Frankfurt am Main, 60590, Germany
Universitatsklinikum Leipzig AoR
Leipzig, 04103, Germany
Johannes Gutenberg-Universitat
Mainz, 55131, Germany
Prince of Wales Hospital
Shatin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Department of Hepatology PGIMER Chandigarh
Chandigarh, 160012, India
Global Clinical Reseaech Services PVT LTD
Hyderabad, 500004, India
Institute of Post Graduate Medical Education and Research (IPGMER)
Kolkata, 700020, India
Dayanand Medical College & Hospital
Ludhiana, 141001, India
Kasturba Medical College Hospital
Mangalore, 575001, India
Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals
Mumbai, 400012, India
Midas Multispecialty Hospital
Nagpur, 440010, 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
Emek Medical Center
Afula, 18341, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
The Lady Davis Carmel Medical Center
Haifa, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, 64239, Israel
Rabin Medical Center
Petah Tikva, 49100, 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
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
Fukui-Ken Saiseikai Hospital
Fukui, 918-8503, Japan
Kyushu University Hospital
Fukuoka, 812-8582, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Hiroshima, 730-8619, Japan
Juntendo University Shizuoka Hospital
Izunokuni, 410-2295, Japan
Kanazawa University Hospital
Kanazawa, 920-8641, Japan
Nara Medical University Hospital
Kashihara, 634-8522, Japan
Toranomon Hospital Kajigaya
Kawasaki, 105-8470, 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
Aichi Medical University Hospital
Nagakute, 480-1195, Japan
Nara City Hospital
Nara, 630-8305, Japan
Kawasaki Medical School General Medical Center
Okayama, 700-8508, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Hirakata Kohsai Hospital
Osaka, 573-0153, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, 856-8562, Japan
Saga University Hospital
Saga, 849-8501, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, 600033, Japan
Tokyo Womens Medical University Hospital
Shinjuku, 162-8666, Japan
Saiseikai Suita Hospital
Suita, 564-0013, Japan
Osaka University Hospital
Suita, 565-0871, Japan
Ehime University Hospital
Tōno, 7910295, Japan
Mie University Hospital
Tsu, 514-8507, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Yokohama City University Hospital
Yokohama, 236-0004, Japan
Consultorio Médico
Mexico City, 6700, Mexico
Accelerium S. de R.L. de C.V.
Monterrey, 64000, Mexico
Auckland City Hospital
Auckland, 1023, New Zealand
Southern District Health Board - Dunedin Hospital
Dunedin, 9016, 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
ID Clinic Arkadiusz Pisula
Mysłowice, 41-400, Poland
Klinical Investigations Group, LLC
San Juan, 00921, Puerto Rico
VA Carribean Healthcare System
San Juan, 00921, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
National University Health System
Singapore, 169856, Singapore
Singapore General Hospital
Singapore, 169856, Singapore
Changi General Hospital Pte Ltd.
Singapore, 529889, 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
Inha University Hospital
Incheon, 22332, South Korea
Seoul National University Bundang Hospital
Seongnam, 463-707, South Korea
Seoul National University Hospital
Seoul, 03830, South Korea
Asan Medical Center
Seoul, 05505, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Gangnam Severance Hospital
Seoul, 135-720, South Korea
Korea University Guro Hospital
Seoul, 152-703, South Korea
Hospital Universitario Fundacion Alcorcon
Alcorcón, 08036, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital del Mar - Parc de Salut
Barcelona, 8003, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Puerto de Hierro Majadahonda
Majadahonda, 28220, Spain
CHOP_Complejo Hospitalario Universitario de Pntevedra
Pontevedra, 36071, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, 46026, Spain
Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
Bern, 3010, Switzerland
Istituto Cantanale di Patologia Locarno
Lugano, 6900, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80099, Taiwan
National Cheng Kung University Hospital
Tainan, 07428, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Chang Gung Medical Foundation-LinKou Branch
Taoyuan District, 333, Taiwan
NHS Greater Glasgow and Clyde
Glasgow, G51 4TF, United Kingdom
Barts Health NHS Trust
London, E1 1BB, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
St. George's Hospital
London, SW170QT, United Kingdom
Imperial College Healthcare NHS Trust
London, W2YN1, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, PL6 8DH, 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.
RESULTHarrison 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: 32147362RESULTLoomba 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: 33307033DERIVEDYounossi 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
January 30, 2017
Primary Completion
May 6, 2019
Study Completion
May 6, 2019
Last Updated
May 7, 2020
Results First Posted
May 7, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy