AzTrials
AzTrials

Nonalcoholic SteatohepatitisPhase 3STELLAR-3NCT03053050

Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

A Phase 3 study testing SEL in people with Nonalcoholic Steatohepatitis, run by Gilead Sciences at 298 sites in 27 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 progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis. 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
808 participants
Where
298 sitesin 27 countries
Study dates
13 Feb 2017to 19 Jun 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 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)

Who cannot join

  • Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
  • Child-Pugh (CP) score > 6, as determined at screening, unless due to therapeutic anti-coagulation
  • Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
  • Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and/ or centralized review of liver histology.
  • History of liver transplantation
  • Current or history of hepatocellular carcinoma (HCC)
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

298 sites in 27 countries.

298 sites in 27 countries

United States124 sites

  • Texas Clinical Research Institute, LLC

    Arlington, Texas, 76012

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Piedmont Transplant Institute

    Atlanta, Georgia, 30309

  • University of Colorado

    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, LLC

    Bastrop, Louisiana, 71021

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Northeast Clinical Research Center, LLC

    Bethlehem, Pennsylvania, 18017

  • 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

  • University of North Carolina at Chapel Hill / UNC School of Medicine

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29245

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Northwestern Memorial Hospital; Clinical Research Unit

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center

    Chicago, Illinois, 60615

  • eStudySite

    Chula Vista, California, 91911

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45249

  • UC Health/Holmes Hospital

    Cincinnati, Ohio, 45267

  • Southern California Liver Centers

    Coronado, California, 92673

  • United Gastroenterologists

    Costa Mesa, California, 92626

  • 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

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • Verity Research, Inc.

    Fairfax, Virginia, 22031

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

  • Cumberland Research Associates, LLC

    Fayetteville, North Carolina, 28304

  • Baylor Scott & White All Saints Medical Center

    Fort Worth, Texas, 76104

  • Fresno Clinical Research Center

    Fresno, California, 93720

  • UF Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • NorthShore University Healthsystem

    Glenview, Illinois, 60026

  • Triad Clinical Trials LLC

    Greensboro, North Carolina, 27410

  • Greenville Health System - Gastroenterology and Liver Center

    Greenville, South Carolina, 29605

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21472

  • Gastroenterology Associates of Hazard

    Hazard, Kentucky, 41707

  • Kelsey-Seybold Clinic

    Houston, Texas, 77025

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030

  • VAMC & Baylor College

    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

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • UF Health Jacksonville-Gastroenterology Emerson

    Jacksonville, Florida, 32207

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Kansas City Gastroenterology and Hepatology

    Kansas City, Missouri, 64131

  • University of California San Diego (UCSD)

    La Jolla, California, 92103

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Emeritas Research Group

    Lansdowne Town Center, Virginia, 20716

  • eStudySite

    Las Vegas, Nevada, 89109

  • Sunrise Medical Research, Inc

    Lauderdale Lakes, Florida, 33319

  • Baptist Medical Center

    Little Rock, Arkansas, 72204

  • Pinnacle Clinical Research, PLLC

    Live Oak, Texas, 78233

  • Ruane Clinical Research Group

    Los Angeles, California, 90036

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Northwell Health - Sandra Atlas Bass Center for Liver Diseases

    Manhasset, New York, 11030

  • Gastrointestinal Specialists of Georgia, PC

    Marietta, Georgia, 30060

  • Sunrise Research Institute

    Miami, Florida, 33130

  • Schiff Center for Liver Diseases/University of Miami

    Miami, Florida, 33136

  • Genoma Research Group, Inc

    Miami, Florida, 33165

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

  • University of Minnesota Medical Center - Fairview

    Minneapolis, Minnesota, 55455

  • Intermountain Liver Disease and Transplant Center

    Murray, Utah, 84107

  • Quality Medical Research PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center - Digestive Disease Center

    Nashville, Tennessee, 37212

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Tulane University Health Sciences Center

    New Orleans, Louisiana, 70112

  • Ocshner Medical Center

    New Orleans, Louisiana, 70121

  • Advanced Research Institute

    New Port Richey, Florida, 34653

  • Icahn School of Medicine at Mount Sinai Beth Israel

    New York, New York, 10003

  • 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, 23602

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72204

  • eStudySite

    Oceanside, California, 92056

  • Avail Clinical Research, LLC

    Orange City, Florida, 32763

  • California Liver Institute

    Pasadena, California, 91105

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

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Banner University Medical Center-Phoenix

    Phoenix, Arizona, 85006

  • 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

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • eStudySite

    Pittsburgh, Pennsylvania, 15251

  • University Gastroenterology

    Providence, Rhode Island, 02905

  • Inland Empire Liver Foundation

    Rialto, California, 92377

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

    Richmond, Virginia, 23226

  • 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, 55095

  • 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 Hospital

    Salt Lake City, Utah, 84132

  • American Research Corporation, The Texas Liver Institute

    San Antonio, Texas, 78215

  • 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

  • Mission Gastroenterology and Hepatology

    San Francisco, California, 94115

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143

  • Silicon Valley Research Institute

    San Jose, California, 95128

  • Guthrie Medical Group, PC

    Sayre, Pennsylvania, 18840

  • Virginia Mason

    Seattle, Washington, 98101

  • Swedish Organ Transplant and Liver Center

    Seattle, Washington, 98104

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Saint Louis University

    St Louis, Missouri, 63104

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

    Statesville, North Carolina, 28625

  • University of Arizona

    Tucson, Arizona, 85724

  • South Florida Center of Gastroenterology, PA

    Wellington, Florida, 33414

  • Digestive Health Specialists, PA

    Winston-Salem, North Carolina, 27103

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

    Wyoming, Michigan, 49519

  • Huron Gastroenterology Associates/Center for Digestive Care

    Ypsilanti, Michigan, 48197

  • Florida Medical Clinic, PA

    Zephyrhills, Florida, 33540

Other trials in United States

Japan37 sites

  • Chiba University Hospital

    Chiba, 260-8670

  • Fukui-Ken Saiseikai Hospital

    Fukui-shi, 918-8503

  • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

    Hiroshima, 730-8619

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Tokyo Medical University Ibaraki Medical Center

    Ibaraki, 300-0395

  • Juntendo University Shizuoka Hospital

    Izunokuni, 410-2295

  • Kagoshima University Medical And Dental Hospital

    Kagoshima, 890-8520

  • Kanazawa University Hospital

    Kanagawa, 920-8641

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Toranomon Hospital Kajigaya

    Kawasaki, 105-8470

  • Shinkokura Hospital

    Kitakyushu, 803-8505

  • 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

  • Japanese Red Cross Musashino Hospital

    Musashino, 180-8610

  • Aichi Medical University Hospital

    Nagakute, 480-1195

  • Heart Life Hospital

    Nakagami, 901-2492

  • Nara City Hospital

    Nara, 630-8305

  • Hyogo College of Medicine Hospital

    Nishinomiya, 663-8501

  • Kawasaki Medical School General Medical Center

    Okayama, 700-808

  • Okayama University Hospital

    Okayama, 700-8558

  • National Hospital Organization Nagasaki Medical Center

    Ōmura, 856-8562

  • National Hospital Organization Osaka National Hospital

    Osaka, 540-0006

  • Hirakata Kohsai Hospital

    Ōsaka, 573-0153

  • Saga University Hospital

    Saga, 849-8501

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

    Sapporo, 600-0033

  • Tohoku Rosai Hospital

    Sendai, 981-8563

  • National Center for Global Health and Medicine Hospital

    Shinjuku-ku, 162-8655

  • Saiseikai Suita Hospital

    Suita, 564-0013

  • Kagawa Prefectural Central Hospital

    Takamatsu, 760-8557

  • Ehime University Hospital

    Tōno, 7190295

  • Mie University Hospital

    Tsu, 514-8507

  • Yamagata University Hospital

    Yamagata, 990-9585

  • Yokohama City University Hospital

    Yokohama, 236-0004

Other trials in Japan

France15 sites

  • 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, 59000

  • CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

    Limoges, 87000

  • Hopital de la Croix Rousse

    Lyon, 69317

  • Hôpital Saint Joseph

    Marseille, 13008

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

    Nice, 06200

  • Hopital Cochin

    Paris, 75014

  • Hopital Beaujon

    Pessac, 33600

  • Centre Hospitalier Universitaire de Bordeaux

    Pessac, 33604

  • Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

    Strasbourg, 67091

  • Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

    Toulouse, 31059

  • Hopital Paul Brousse

    Villejuif, 94800

Other trials in France

Taiwan12 sites

  • Changhua Christian Hospital

    Chang-hua, 500

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital

    Chiayi City, 60002

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80099

  • E-DA Hospital

    Kaohsiung City, 82445

  • Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital

    Keelung, 20401

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospitalv

    Tainan, 7428

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memorial Hospital

    Taipei, 10449

  • Cathay General Hospital

    Taipei, 10630

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

Canada11 sites

  • William Osler Health System-Brampton Civic Hospital

    Brampton, Ontario

  • South Shore Medical Arts

    Bridgewater, Nova Scotia, B4V 3N2

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

    Calgary, Alberta, T2N 4Z6

  • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

    Edmonton, Alberta, T6G 2X8

  • South Shore Medical Arts

    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

  • LAIR Centre

    Vancouver, British Columbia, V5Z 1H2

  • Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • PerCuro Clinical Research Ltd.

    Victoria, British Columbia, V8T 5G4

Other trials in Canada

South Korea11 sites

  • Keimyung University Dongsan Medical Center

    Daegu, 41931

  • Kyungpook National University Hospital

    Daegu, 700-721

  • National Health Insurance Service- Ilsan Hospital

    Goyang-si, 10444

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Asan Medical Center

    Seoul, 05505

  • Chung-Ang University Hospital

    Seoul, 06973

  • Severance Hospital, Yonsei University Health System

    Seoul, 120-752

  • Gangnam Severance Hospital

    Seoul, 135-720

  • Korea University Guro Hospital

    Seoul, 152-703

  • SMG-SNU Boramae Medical Center

    Seoul, 37061

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 26426

Other trials in South Korea

Australia10 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Health, Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • 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

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

United Kingdom10 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Derby Teaching Hospitals NHS FT

    Derby, DE22 3NE

  • University Hospitals Birmingham NHS Foundation Trust

    Edgbaston, B15 2TH

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

  • Imperial College Healthcare NHS Trust

    London, W21NY

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE2 3HH

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    Norwich, NR4 7UY

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

  • Portsmouth Hospitals NHS Trust

    Portsmouth, PO6 3LY

  • Abertawe Bro Morgannwg University Health Board

    Swansea, SA2 8QA

Other trials in United Kingdom

Germany9 sites

  • Uniklinik RWTH Aachen, Medizinische Klinik III

    Aachen, 52074

  • Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)

    Berlin, 13353

  • Universitatsklinikum Bonn (AoR)

    Bonn, 53105

  • Universitatsklinikum Frankfurt der Goethe-Universitat

    Frankfurt, 60590

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Uniklinikum des Saarlandes- Klinik fur Innere Medizin II

    Homburg, 66421

  • Gastroenterologisch- Hepatologisches Zentrum Kiel

    Kiel, 24146

  • Eugastro Gmbh

    Leipzig, 04103

  • Johannes Gutenberg-Universitat

    Mainz, 55131

Other trials in Germany

Spain9 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Puerto de Hierro Majadahonda

    Majadahonda, 28220

  • CHOP_Complejo Hospitalrio Universitario de Pontevedra

    Pontevedra, 36071

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

India8 sites

  • Institute of Post Graduate Medical Education and Research / SSKM Hospital

    Kolkata, 700020

  • Kasturba Medical College (KMC) Hospital

    Mangalore, 575001

  • Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)

    Mumbai, 400012

  • Midas Multispecialty Hospital

    Nagpur, Maharashtra, 440010

  • Maharaja Agrasen Hospital

    New Delhi, 110026

  • 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

Brazil5 sites

  • Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP

    Botucatu, 18618-000

  • Hospital de Clínicas de Porto Alegre - HCPA/UFRGS

    Porto Alegre, CEP 90035-903

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

    Ribeirão Preto, 14048-900

  • Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

    São Paulo, 01246-903

  • Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)

    São Paulo, 04040-003

Other trials in Brazil

Israel5 sites

  • Rambam Health Care Campus

    Haifa, 30196

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Holy Family hospital

    Nazareth, 91008

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Singapore5 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169856

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital Pte Ltd.

    Singapore, 529889

  • Khoo Teck Puat Hospital

    Singapore, 768828

Other trials in Singapore

Belgium3 sites

  • CUB Hopital Erasme

    Brussels, 1070

  • UZ Brussel

    Brussels, 1090

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

Other trials in Belgium

Italy3 sites

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera Universitaria Pisana

    Pisa, 56124

  • IRCCS Ospedale Casa Sollievo Della Soferrenza

    San Giovanni Rotondo, 71013

Other trials in Italy

Mexico3 sites

  • Phylasis Clinicas Research S. de RL de CV.

    Cuautitlán, 54769

  • Consultorio Médico

    Mexico City, 6700

  • Investigaciones Medicas Cisneros SC

    Monterrey, 64000

Other trials in Mexico

Puerto Rico3 sites

  • Klinical Investigations Group, LLC

    San Juan, 00907

  • VA Caribbean Healthcare System

    San Juan, 00921

  • Fundacion de Investigacion de Diego

    San Juan, 00927

Other trials in Puerto Rico

Argentina2 sites

  • Hospital Italiano de Buenos Aires

    Buenos Aires, 450

  • Instituto Oulton

    Córdoba, X5000JJS

Other trials in Argentina

Austria2 sites

  • Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

    Graz, A-8036

  • Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Hong Kong2 sites

  • Alice Ho Miu Ling Nethersole Hospital

    Tai Po

  • Tuen Mun Hospital

    Tuenmen

Other trials in Hong Kong

Malaysia2 sites

  • Hospital Selayang

    Batu Caves, 68100

  • University of Malaya Medical Centre

    Kuala Lumpur, 50603

Other trials in Malaysia

Poland2 sites

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

    Bytom, 41-902

  • Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

    Lodz, 91-347

Other trials in Poland

Switzerland2 sites

  • Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie

    Bern, 3010

  • Istituto Cantonale di Patologia Locarno

    Lugano, 6900

Other trials in Switzerland

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht, 3508 GA

Other trials in Netherlands

New Zealand1 site

  • Auckland City Hospital

    Grafton, 1023

Other trials in New Zealand

Portugal1 site

  • Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E

    Vila Real, 5000

Other trials in Portugal

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

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.

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 NCT03053050
Study groupRoleWhat they receive
SEL 18 mgExperimentalRandomized 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.
Receives: Drug: SEL; Drug: Placebo to match SEL 6 mg
SEL 6 mgExperimentalRandomized 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.
Receives: Drug: SEL; Drug: Placebo to match SEL 18 mg
PlaceboPlacebo 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.
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 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.

    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 progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.

    Measured: Week 240

Secondary outcomes (6)

  1. Percentage of Participants Who Had Progression to Cirrhosis at Week 48

    Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from < 4 at baseline to 4 at Week 48.

    Measured: Week 48

  2. 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

  3. 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

  4. 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

  5. Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48

    NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.

    Measured: Week 48

  6. Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240

    NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.

    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 start13 Feb 2017
  3. Primary completion19 Jun 2019
  4. Study completion19 Jun 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
808 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03053050
Sponsor's protocol ID
GS-US-384-1943
Other IDs
2016-004374-18, 2016
Acronym
STELLAR-3
Status last verified
Jun 2020
First submitted
10 Feb 2017
Last updated
29 Jun 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

  • 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

  • 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

  • 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 298 sites in 27 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 6 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 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 298 sites in United States, Japan, France, Taiwan, Canada and 22 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 29 Jun 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 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 (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 NCT03053050, 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 29 Jun 2020.

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