AzTrials
AzTrials

Nonalcoholic SteatohepatitisPhase 3STELLAR-4NCT03053063

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

A Phase 3 study testing SEL in people with Nonalcoholic Steatohepatitis, run by Gilead Sciences at 283 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
SEL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
883 participants
Where
283 sitesin 22 countries
Study dates
30 Jan 2017to 6 May 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic anti-coagulation
  • Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
  • Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology.
  • History of liver transplantation
  • Current or history of hepatocellular carcinoma (HCC)
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

283 sites in 22 countries.

283 sites in 22 countries

United States128 sites

  • AccumetRx Clinical Research

    Albuquerque, New Mexico, 87109

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Piedmont Transplant Institute

    Atlanta, Georgia, 30309

  • University of Colorado Denver and Hospital

    Aurora, Colorado, 80045

  • Pinnacle Clinical Research, PLLC

    Austin, Texas, 78746

  • Austin Center for Clinical Research

    Austin, Texas, 78756

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Delta Research Partners

    Bastrop, Louisiana, 71021

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • University of Buffalo, Clinical and Translational Research Center

    Buffalo, New York, 14230

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Institute of Liver Health

    Chandler, Arizona, 85224

  • NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina, University Hospital

    Charleston, South Carolina, 29425

  • Carolinas HealthCare System Center for Liver Disease

    Charlotte, North Carolina, 28204

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Northwestern Memorial Hospital; Clinical Research Unit

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Chicago Medical Center

    Chicago, Illinois, 60615

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Iowa Digestive Disease Center, P.C.

    Clive, Iowa, 50325

  • Columbus Regional Research Institute

    Columbus, Georgia, 31904

  • Southern California Research Center

    Coronado, California, 92118

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Texas Digestive Disease Consultants

    Dallas, Texas, 75246

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Integrity Clinical Research, LLC

    Doral, Florida, 33166

  • Duke University Medical Center - Duke South Clinics

    Durham, North Carolina, 27710

  • South Denver Gastroenterology, PC

    Englewood, Colorado, 80113

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Cumberland Research Associates LLC

    Fayetteville, North Carolina, 28304

  • Fresno Clinical Research Center

    Fresno, California, 93720

  • University of Florida Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • NorthShore University HealthSystem - Glenbrook ACC

    Glenview, Illinois, 60026

  • Greenville Health System Gastroenterology and Liver Center

    Greenville, South Carolina, 29605

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky, 41707

  • Penn State University, The Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Clinical Research of Homestead

    Homestead, Florida, 33030

  • Kelsey-Seybold Clinic

    Houston, Texas, 77025

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Liver Associates of Texas, P.A.

    Houston, Texas, 77030

  • Research Specialists of Texas

    Houston, Texas, 77030

  • Smith Clinic

    Houston, Texas, 77030

  • Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease

    Huntersville, North Carolina, 28078

  • Indiana University Health - University Hospital

    Indianapolis, Indiana, 46202

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Scripps Clinical Research Services

    La Jolla, California, 92037

  • University of California, San Diego (Altman Clinical and Translational Research Center)

    La Jolla, California, 92093

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Baptist Medical Center

    Little Rock, Arkansas, 72204

  • Pinnacle Clinical Research

    Live Oak, Texas, 78233

  • Ruane Clinical Research Group

    Los Angeles, California, 90036

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center

    Los Angeles, California, 90073

  • University of Louisville Clinical Trials Unit

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • Northwell Health - Sandra Atlas Bass Center for Liver Diseases

    Manhasset, New York, 11030

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research

    Memphis, Tennessee, 38104

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136

  • Intermountain Liver Disease and Transplant Clinic

    Murray, Utah, 84107

  • Quality Medical Research PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center - Digestive Disease Center

    Nashville, Tennessee, 37232

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ocshner Medical Center

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai Beth Israel

    New York, New York, 10003

  • NYU Langone Medical Center

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Rutgers New Jersey Medical School- Doctors Office Center

    Newark, New Jersey, 07102

  • Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

    Newport News, Virginia, 23226

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Florida Hospital Transplant Institute

    Orlando, Florida, 32804

  • IMIC Inc

    Palmetto, Florida, 33157

  • California Liver Research Institute

    Pasadena, California, 91105

  • Huntington Medical Research Institutes (HMRI) Liver Center

    Pasadena, California, 91105

  • Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute

    Pittsburgh, Pennsylvania, 15213

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • DHAT Research Institute

    Richardson, Texas, 75082

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Southern Therapy and Advanced Research LLC (STAR)

    Ridgeland, Mississippi, 39157

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • PMG Research of Rocky Mount, LLC

    Rocky Mount, North Carolina, 27804

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • University of Utah

    Salt Lake City, Utah, 84132

  • American Research Corporation, The Texas Liver Institute

    San Antonio, Texas, 78215

  • Research and Education, Inc.

    San Diego, California, 92105

  • Medical Associates Research Group

    San Diego, California, 92123

  • Kaiser Permanente

    San Diego, California, 92514

  • California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant

    San Francisco, California, 94115

  • eStudySite

    San Francisco, California, 94115

  • University of California, San Francisco-Liver Clinic

    San Francisco, California, 94143

  • Virginia Mason

    Seattle, Washington, 98101

  • Swedish Organ Transplant and Liver Center

    Seattle, Washington, 98104

  • University of Washington

    Seattle, Washington, 98195

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Saint Louis University

    St Louis, Missouri, 63104

  • Piedmont Healthcare

    Statesville, North Carolina, 28677

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Island View Gastroenterology Associates- Ventura

    Ventura, California, 93003

  • South Florida Center of Gastroenterology, PA

    Wellington, Florida, 33414

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan, 49519

  • Florida Medical Clinic, PA

    Zephyrhills, Florida, 33540

Other trials in United States

Japan29 sites

  • Fukui-Ken Saiseikai Hospital

    Fukui, 918-8503

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619

  • Juntendo University Shizuoka Hospital

    Izunokuni, 410-2295

  • Kanazawa University Hospital

    Kanazawa, 920-8641

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Toranomon Hospital Kajigaya

    Kawasaki, 105-8470

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655

  • Kurume University Hospital

    Kurume, 830-0011

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Shinshu University Hospital

    Matsumoto, 390-8621

  • Toranomon Hospital

    Minato, 105-8470

  • Miyazaki Medical Center Hospital

    Miyazaki, 880-0003

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Nara City Hospital

    Nara, 630-8305

  • Kawasaki Medical School General Medical Center

    Okayama, 700-8508

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, 856-8562

  • Hirakata Kohsai Hospital

    Osaka, 573-0153

  • Saga University Hospital

    Saga, 849-8501

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

    Sapporo, 600033

  • Tokyo Womens Medical University Hospital

    Shinjuku, 162-8666

  • Saiseikai Suita Hospital

    Suita, 564-0013

  • Osaka University Hospital

    Suita, 565-0871

  • Ehime University Hospital

    Tōno, 7910295

  • Mie University Hospital

    Tsu, 514-8507

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Hospital

    Yokohama, 236-0004

Other trials in Japan

France16 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49033

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, 63003

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Grenoble- Hopital Michallon

    Grenoble, 38043

  • Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

    Lille, 59037

  • CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

    Limoges, 87042

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Hôpital Saint Joseph

    Marseille, 13008

  • CHU de Montpellier, Hopital St Eloi

    Montpellier, 34925

  • Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2

    Nice, 06200

  • Hopital Cochin

    Paris, 75014

  • Groupe Hospitalier Universitaire La Pitie Salpetriere

    Paris, 75651

  • Hopital Beaujon

    Pessac, 33600

  • Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

    Strasbourg, 67091

  • Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

    Toulouse, 31059

Other trials in France

Canada15 sites

  • William Osler Health System-Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • South Shore Medical Arts

    Bridgewater, Nova Scotia, B4V 3N2

  • University of Calgary Liver Unit (Heritage Medical Research Clinic)

    Calgary, Alberta, T2N 4Z6

  • GI Research

    Edmonton, Alberta, T5H 4B9

  • University of Alberta

    Edmonton, Alberta, T6G 2R3

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • McMaster University Medical Centre

    Hamilton, Ontario, L8S 4L8

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3JI

  • Toronto Center for Liver Diseases (TCLD), Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Liver Centre

    Toronto, Ontario, M6H 3M1

  • LAIR Centre

    Vancouver, British Columbia, V5Z 1HZ

  • Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

    Vancouver, British Columbia, V5Z 1M9

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, V8T 5G4

  • University of Manitoba, Health Sciences Centre, John Buhler Research Centre

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Health

    Heidelberg, Victoria, 3081

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

  • St. George's Hospital

    Kogarah, New South Wales, 2217

  • The Alfred Hospital, Alfred Health

    Melbourne, Victoria, 3004

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Spain11 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, 08036

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital del Mar - Parc de Salut

    Barcelona, 8003

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario Puerto de Hierro Majadahonda

    Majadahonda, 28220

  • CHOP_Complejo Hospitalario Universitario de Pntevedra

    Pontevedra, 36071

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

India10 sites

  • Department of Hepatology PGIMER Chandigarh

    Chandigarh, 160012

  • Global Clinical Reseaech Services PVT LTD

    Hyderabad, 500004

  • Institute of Post Graduate Medical Education and Research (IPGMER)

    Kolkata, 700020

  • Dayanand Medical College & Hospital

    Ludhiana, 141001

  • Kasturba Medical College Hospital

    Mangalore, 575001

  • Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals

    Mumbai, 400012

  • Midas Multispecialty Hospital

    Nagpur, 440010

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Fortis Flt. Lt. Rajan Dhall Hospital

    New Delhi, 110070

  • Institute of Liver & Biliary Sciences

    New Delhi, 110070

Other trials in India

South Korea10 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Kyungpook National University Hospital

    Daegu, 700-721

  • National Health Insurance Service- Ilsan Hospital

    Goyang-si, 10444

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam, 463-707

  • Seoul National University Hospital

    Seoul, 03830

  • Asan Medical Center

    Seoul, 05505

  • SMG-SNU Boramae Medical Center

    Seoul, 07061

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Korea University Guro Hospital

    Seoul, 152-703

Other trials in South Korea

United Kingdom9 sites

  • NHS Greater Glasgow and Clyde

    Glasgow, G51 4TF

  • Barts Health NHS Trust

    London, E1 1BB

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

  • St. George's Hospital

    London, SW170QT

  • Imperial College Healthcare NHS Trust

    London, W2YN1

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Plymouth Hospitals NHS Trust

    Plymouth, PL6 8DH

  • Portsmouth Hospitals NHS Trust

    Portsmouth, PO6 3LY

  • Abertawe Bro Morgannwg University Health Board

    Swansea, SA2 8QA

Other trials in United Kingdom

Israel7 sites

  • Emek Medical Center

    Afula, 18341

  • Rambam Health Care Campus

    Haifa, 31096

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, 64239

  • Rabin Medical Center

    Petah Tikva, 49100

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Belgium5 sites

  • CUB Hopital Erasme

    Brussels, 10070

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires UCL Saint-Luc

    Brussels, 1200

  • Az Maria Middelares Ghent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Germany5 sites

  • Uniklinik RWTH Aachen, Medizinische Klinik III

    Aachen, 52074

  • Universitatsklinikum Bonn (AoR)

    Bonn, 53105

  • Universitatsklinikum Frankfurt der Goethe-Universitat

    Frankfurt am Main, 60590

  • Universitatsklinikum Leipzig AoR

    Leipzig, 04103

  • Johannes Gutenberg-Universitat

    Mainz, 55131

Other trials in Germany

Taiwan4 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80099

  • National Cheng Kung University Hospital

    Tainan, 07428

  • National Taiwan University Hospital

    Taipei, 10002

  • Chang Gung Medical Foundation-LinKou Branch

    Taoyuan, 333

Other trials in Taiwan

Poland3 sites

  • Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii

    Bytom, 41-902

  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

    Lodz, 91-347

  • ID Clinic Arkadiusz Pisula

    Mysłowice, 41-400

Other trials in Poland

Puerto Rico3 sites

  • Klinical Investigations Group, LLC

    San Juan, 00921

  • VA Carribean Healthcare System

    San Juan, 00921

  • Fundacion de Investigacion de Diego

    San Juan, 00927

Other trials in Puerto Rico

Singapore3 sites

  • National University Health System

    Singapore, 169856

  • Singapore General Hospital

    Singapore, 169856

  • Changi General Hospital Pte Ltd.

    Singapore, 529889

Other trials in Singapore

Austria2 sites

  • Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

    Graz, A-8036

  • Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Hong Kong2 sites

  • Prince of Wales Hospital

    Shatin

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po

Other trials in Hong Kong

Italy2 sites

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Mexico2 sites

  • Consultorio Médico

    Mexico City, 6700

  • Accelerium S. de R.L. de C.V.

    Monterrey, 64000

Other trials in Mexico

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1023

  • Southern District Health Board - Dunedin Hospital

    Dunedin, 9016

Other trials in New Zealand

Switzerland2 sites

  • Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie

    Bern, 3010

  • Istituto Cantanale di Patologia Locarno

    Lugano, 6900

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

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.

Being tested
SEL, Placebo to match SEL 6 mg, Placebo to match SEL 18 mg
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SELDrug

    Also called selonsertib, GS-4997

    Tablets administered orally once daily

  • Placebo to match SEL 6 mgDrug

    Tablets administered orally once daily

  • Placebo to match SEL 18 mgDrug

    Tablets administered orally once daily

Study groups in NCT03053063
Study groupRoleWhat they receive
SEL 6 mgExperimentalRandomized 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.
Receives: Drug: SEL; Drug: Placebo to match SEL 18 mg
SEL 18 mgExperimentalRandomized 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.
Receives: Drug: SEL; Drug: Placebo to match SEL 6 mg
PlaceboPlacebo 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.
Receives: Drug: Placebo to match SEL 6 mg; Drug: Placebo to match SEL 18 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 48

  2. 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.

    Measured: Week 240

Secondary outcomes (5)

  1. 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.

    Measured: Week 240

  2. 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).

    Measured: Week 48

  3. 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).

    Measured: Week 240

  4. Percentage of Participants Who Had NASH Resolution at Week 48

    NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.

    Measured: Week 48

  5. Percentage of Participants Who Had NASH Resolution at Week 240

    NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning reduced to 0 from a value ≥ 1 at baseline; both criteria were necessary conditions.As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1.

    Measured: Week 240

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2017
  2. Study start30 Jan 2017
  3. Primary completion6 May 2019
  4. Study completion6 May 2019

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
883 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053063
Sponsor's protocol ID
GS-US-384-1944
Other IDs
2016-004148-13, 2016
Acronym
STELLAR-4
Status last verified
Apr 2020
First submitted
10 Feb 2017
Last updated
7 May 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 31271665

  • 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.

  • 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.

    PubMed 30779990

  • 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.

  • 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.

  • 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.

  • 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.

  • 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; 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.

    PubMed 32147362

  • Loomba 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.

    PubMed 36750244

  • 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.

    PubMed 33307033

  • 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.

    PubMed 30639779

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SEL in people with Nonalcoholic Steatohepatitis, run by Gilead Sciences at 283 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 283 sites in United States, Japan, France, Canada, Australia and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03053063, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.

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