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

PHASE3TerminatedINTERVENTIONAL
Enrollment

808

Participants

Timeline

Start Date

February 13, 2017

Primary Completion Date

June 19, 2019

Study Completion Date

June 19, 2019

Conditions
Nonalcoholic Steatohepatitis
Interventions
DRUG

SEL

Tablets administered orally once daily

DRUG

Placebo to match SEL 6 mg

Tablets administered orally once daily

DRUG

Placebo to match SEL 18 mg

Tablets administered orally once daily

Trial Locations (298)

450

Hospital Italiano de Buenos Aires, Buenos Aires

500

Changhua Christian Hospital, Chang-hua

1023

Auckland City Hospital, Grafton

1070

CUB Hopital Erasme, Brussels

1090

Allgemeines Krankenhaus Wien, Vienna

UZ Brussel, Brussels

2010

St. Vincent's Hospital Sydney, Darlinghurst

2145

Westmead Hospital, Westmead

2217

St. George's Hospital, Kogarah

3000

Universitaire Ziekenhuizen Leuven, Leuven

3004

The Alfred Hospital, Alfred Health, Melbourne

3010

Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie, Bern

3065

St. Vincent's Hospital Melbourne, Fitzroy

3084

Austin Hospital, Heidelberg

3168

Monash Health, Monash Medical Centre, Clayton

4029

Royal Brisbane & Women's Hospital, Herston

5000

Royal Adelaide Hospital, Adelaide

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

6000

Royal Perth Hospital, Perth

6700

Consultorio Médico, Mexico City

6900

Istituto Cantonale di Patologia Locarno, Lugano

7428

National Cheng Kung University Hospitalv, Tainan City

10002

National Taiwan University Hospital, Taipei

10003

Icahn School of Medicine at Mount Sinai Beth Israel, New York

10444

National Health Insurance Service- Ilsan Hospital, Goyang-si

10449

Mackay Memorial Hospital, Taipei

10630

Cathay General Hospital, Taipei

11030

Northwell Health - Sandra Atlas Bass Center for Liver Diseases, Manhasset

11217

Taipei Veterans General Hospital, Taipei

13008

Hôpital Saint Joseph, Marseille

13353

Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp), Berlin

14230

University of Buffalo, Clinical and Translational Research Center, Buffalo

14642

University of Rochester Medical Center, Rochester

15213

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

15240

VA Pittsburgh Healthcare System, Pittsburgh

15251

eStudySite, Pittsburgh

18017

Northeast Clinical Research Center, LLC, Bethlehem

18840

Guthrie Medical Group, PC, Sayre

19104

Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20401

Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital, Keelung

20716

Emeritas Research Group, Lansdowne Town Center

20889

Walter Reed National Military Medical Center, Bethesda

21202

Mercy Medical Center, Baltimore

21228

Digestive Disease Associates, PA, Catonsville

21472

Meritus Center for Clinical Research, Hagerstown

22031

Verity Research, Inc., Fairfax

22042

Inova Fairfax Medical Campus, Falls Church

22908

University of Virginia Medical Center, Charlottesville

23226

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

23249

McGuire VA Medical Center, Richmond

23298

Virginia Commonwealth University, Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

23602

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

24146

Gastroenterologisch- Hepatologisches Zentrum Kiel, Kiel

26426

Yonsei University Wonju Severance Christian Hospital, Wŏnju

27103

Digestive Health Specialists, PA, Winston-Salem

27410

Triad Clinical Trials LLC, Greensboro

27599

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

27710

Duke University Medical Center - Duke South Clinics, Durham

27804

PMG Research of Rocky Mount, LLC, Rocky Mount

28046

Hospital Universitario La Paz, Madrid

28078

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

28220

Hospital Puerto de Hierro Majadahonda, Majadahonda

28304

Cumberland Research Associates, LLC, Fayetteville

28625

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

29245

Medical University of South Carolina, Charleston

29605

Greenville Health System - Gastroenterology and Liver Center, Greenville

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30196

Rambam Health Care Campus, Haifa

30309

Digestive Healthcare of Georgia, Atlanta

Piedmont Transplant Institute, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

31059

Centre Hospitalier Universitaire de Toulouse- Hopital Purpan, Toulouse

32207

UF Health Jacksonville-Gastroenterology Emerson, Jacksonville

32610

UF Hepatology Research at CTRB, Gainesville

32763

Avail Clinical Research, LLC, Orange City

33130

Sunrise Research Institute, Miami

33136

Schiff Center for Liver Diseases/University of Miami, Miami

33165

Genoma Research Group, Inc, Miami

33166

Integrity Clinical Research, LLC, Doral

33305

Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital, Taoyuan District

33319

Sunrise Medical Research, Inc, Lauderdale Lakes

33414

South Florida Center of Gastroenterology, PA, Wellington

33540

Florida Medical Clinic, PA, Zephyrhills

33600

Hopital Beaujon, Pessac

33604

Centre Hospitalier Universitaire de Bordeaux, Pessac

34211

Florida Research Institute, Lakewood Rch

34653

Advanced Research Institute, New Port Richey

36071

CHOP_Complejo Hospitalrio Universitario de Pontevedra, Pontevedra

37061

SMG-SNU Boramae Medical Center, Seoul

37211

Quality Medical Research PLLC, Nashville

37212

Vanderbilt University Medical Center - Digestive Disease Center, Nashville

37421

WR-ClinSearch, LLC, Chattanooga

38043

CHU de Grenoble- Hopital Michallon, Grenoble

38138

Gastro One, Germantown

39008

Hospital Universitario Marques de Valdecilla, Santander

39157

Southern Therapy and Advanced Research LLC (STAR), Ridgeland

40705

Taichung Veterans General Hospital, Taichung

41013

Hospital Universitario Virgen del Rocio, Seville

41707

Gastroenterology Associates of Hazard, Hazard

41931

Keimyung University Dongsan Medical Center, Daegu

45249

Consultants for Clinical Research, Cincinnati

45267

UC Health/Holmes Hospital, Cincinnati

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

46202

Indiana University Health - University Hospital, Indianapolis

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

48197

Huron Gastroenterology Associates/Center for Digestive Care, Ypsilanti

48202

Henry Ford Health System, Detroit

49033

Centre Hospitalier Universitaire d'Angers, Angers

49519

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

50603

University of Malaya Medical Centre, Kuala Lumpur

52074

Uniklinik RWTH Aachen, Medizinische Klinik III, Aachen

52242

University of Iowa Hospitals and Clinics, Iowa City

52621

The Chaim Sheba Medical Center, Ramat Gan

53105

Universitatsklinikum Bonn (AoR), Bonn

53226

Froedtert Memorial Lutheran Hospital, Milwaukee

54769

Phylasis Clinicas Research S. de RL de CV., Cuautitlán

55095

Mayo Clinic, Rochester

55131

Johannes Gutenberg-Universitat, Mainz

55455

University of Minnesota Medical Center - Fairview, Minneapolis

56124

Azienda Ospedaliera Universitaria Pisana, Pisa

59000

Centre Hospitalier Regional Universitaire- Hopital Claude Huriez, Lille

60002

Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chiayi City

60026

NorthShore University Healthsystem, Glenview

60590

Universitatsklinikum Frankfurt der Goethe-Universitat, Frankfurt

60611

Northwestern Memorial Hospital; Clinical Research Unit, Chicago

60615

The University of Chicago Medical Center, Chicago

63003

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand

63104

Saint Louis University, St Louis

64000

Investigaciones Medicas Cisneros SC, Monterrey

64111

Saint Luke's Hospital of Kansas City, Kansas City

64131

Kansas City Gastroenterology and Hepatology, Kansas City

64239

Tel-Aviv Sourasky Medical Center, Tel Aviv

66160

University of Kansas Medical Center, Kansas City

66421

Uniklinikum des Saarlandes- Klinik fur Innere Medizin II, Homburg

67091

Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil, Strasbourg

68100

Hospital Selayang, Batu Caves

69317

Hopital de la Croix Rousse, Lyon

70112

Tulane University Health Sciences Center, New Orleans

70121

Ocshner Medical Center, New Orleans

71013

IRCCS Ospedale Casa Sollievo Della Soferrenza, San Giovanni Rotondo

71021

Delta Research Partners, LLC, Bastrop

71105

Louisiana Research Center, LLC, Shreveport

72204

Baptist Medical Center, Little Rock

Arkansas Gastroenterology, North Little Rock

75014

Hopital Cochin, Paris

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75246

Texas Digestive Disease Consultants, Dallas

76012

Texas Clinical Research Institute, LLC, Arlington

76104

Baylor Scott & White All Saints Medical Center, Fort Worth

77025

Kelsey-Seybold Clinic, Houston

77030

Baylor College of Medicine - Advanced Liver Therapies, Houston

VAMC & Baylor College, Houston

78215

American Research Corporation, The Texas Liver Institute, San Antonio

78233

Pinnacle Clinical Research, PLLC, Live Oak

78746

Pinnacle Clinical Research, PLLC, Austin

78756

Austin Center for Clinical Research, Austin

80045

University of Colorado, Aurora

80099

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

82445

E-DA Hospital, Kaohsiung City

84107

Intermountain Liver Disease and Transplant Center, Murray

84132

University of Utah Hospital, Salt Lake City

85006

Banner University Medical Center-Phoenix, Phoenix

85013

St. Joseph's Hospital and Medical Center, Phoenix

85054

Mayo Clinic, Phoenix

85224

Institute of Liver Health, Chandler

85724

University of Arizona, Tucson

87000

CHU de Limoges- Hopital Dupuytren- Federation Hepatologie, Limoges

89109

eStudySite, Las Vegas

90036

Ruane Clinical Research Group, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90073

VA Greater Los Angeles Healthcare System, Los Angeles

91008

Holy Family hospital, Nazareth

91105

California Liver Institute, Pasadena

91911

eStudySite, Chula Vista

92020

TriWest Research Associates, LLC, El Cajon

92056

eStudySite, Oceanside

92103

University of California San Diego (UCSD), La Jolla

92123

Medical Associates Research Group, San Diego

92377

Inland Empire Liver Foundation, Rialto

92514

Kaiser Permanente, San Diego

92626

United Gastroenterologists, Costa Mesa

92673

Southern California Liver Centers, Coronado

93720

Fresno Clinical Research Center, Fresno

94010

Hopital Henri Mondor, Créteil

94115

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

Mission Gastroenterology and Hepatology, San Francisco

94143

University of California San Francisco (UCSF), San Francisco

94800

Hopital Paul Brousse, Villejuif

95128

Silicon Valley Research Institute, San Jose

95817

University of California, Davis Medical Center, Sacramento

98101

Virginia Mason, Seattle

98104

Swedish Organ Transplant and Liver Center, Seattle

110026

Maharaja Agrasen Hospital, New Delhi

110029

All India Institute of Medical Sciences, New Delhi

110070

Fortis Flt. Lt. Rajan Dhall Hospital, New Delhi

Institute of Liver & Biliary Sciences, New Delhi

119074

National University Hospital, Singapore

169856

Singapore General Hospital, Singapore

308433

Tan Tock Seng Hospital, Singapore

400012

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

440010

Midas Multispecialty Hospital, Nagpur

529889

Changi General Hospital Pte Ltd., Singapore

575001

Kasturba Medical College (KMC) Hospital, Mangalore

700020

Institute of Post Graduate Medical Education and Research / SSKM Hospital, Kolkata

768828

Khoo Teck Puat Hospital, Singapore

3436212

The Lady Davis Carmel Medical Center, Haifa

7190295

Ehime University Hospital, Tōno

06510

Yale University School of Medicine, New Haven

07102

Rutgers New Jersey Medical School- Doctors Office Center, Newark

02905

University Gastroenterology, Providence

05401

The University of Vermont Medical Center, Burlington

X5000JJS

Instituto Oulton, Córdoba

A-8036

Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin, Graz

18618-000

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

CEP 90035-903

Hospital de Clínicas de Porto Alegre - HCPA/UFRGS, Porto Alegre

14048-900

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

01246-903

Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo, São Paulo

04040-003

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

T2N 4Z6

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

T6G 2X8

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

V5Z 1H2

LAIR Centre, Vancouver

V5Z 1M9

Gordon and Leslie Diamond Health Care Centre, Vancouver

V6Z 2K5

(G.I.R.I.) GI Research Institute, Vancouver

V8T 5G4

PerCuro Clinical Research Ltd., Victoria

B4V 3N2

South Shore Medical Arts, Bridgewater

Unknown

William Osler Health System-Brampton Civic Hospital, Brampton

Alice Ho Miu Ling Nethersole Hospital, Tai Po

Tuen Mun Hospital, Tuenmen

N6A 5A5

South Shore Medical Arts, London

M5G 2C4

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

H4A 3JI

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

06200

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

04103

Eugastro Gmbh, Leipzig

260-8670

Chiba University Hospital, Chiba

918-8503

Fukui-Ken Saiseikai Hospital, Fukui-shi

730-8619

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima

734-8551

Hiroshima University Hospital, Hiroshima

300-0395

Tokyo Medical University Ibaraki Medical Center, Ibaraki

410-2295

Juntendo University Shizuoka Hospital, Izunokuni

890-8520

Kagoshima University Medical And Dental Hospital, Kagoshima

920-8641

Kanazawa University Hospital, Kanagawa

634-8522

Nara Medical University Hospital, Kashihara

105-8470

Toranomon Hospital Kajigaya, Kawasaki

Toranomon Hospital, Minato

803-8505

Shinkokura Hospital, Kitakyushu

862-8655

Kumamoto Shinto General Hospital, Kumamoto

830-0011

Kurume University Hospital, Kurume

602-8566

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

390-8621

Shinshu University Hospital, Matsumoto

880-0003

Miyazaki Medical Center Hospital, Miyazaki

180-8610

Japanese Red Cross Musashino Hospital, Musashino

480-1195

Aichi Medical University Hospital, Nagakute

901-2492

Heart Life Hospital, Nakagami

630-8305

Nara City Hospital, Nara

663-8501

Hyogo College of Medicine Hospital, Nishinomiya

700-808

Kawasaki Medical School General Medical Center, Okayama

700-8558

Okayama University Hospital, Okayama

540-0006

National Hospital Organization Osaka National Hospital, Osaka

856-8562

National Hospital Organization Nagasaki Medical Center, Ōmura

573-0153

Hirakata Kohsai Hospital, Ōsaka

849-8501

Saga University Hospital, Saga

600-0033

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

981-8563

Tohoku Rosai Hospital, Sendai

162-8655

National Center for Global Health and Medicine Hospital, Shinjuku-ku

564-0013

Saiseikai Suita Hospital, Suita

760-8557

Kagawa Prefectural Central Hospital, Takamatsu

514-8507

Mie University Hospital, Tsu

990-9585

Yamagata University Hospital, Yamagata

236-0004

Yokohama City University Hospital, Yokohama

3508 GA

University Medical Center Utrecht, Utrecht

41-902

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

91-347

Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Lodz

00907

Klinical Investigations Group, LLC, San Juan

00921

VA Caribbean Healthcare System, San Juan

00927

Fundacion de Investigacion de Diego, San Juan

700-721

Kyungpook National University Hospital, Daegu

04763

Hanyang University Seoul Hospital, Seoul

05505

Asan Medical Center, Seoul

06973

Chung-Ang University Hospital, Seoul

120-752

Severance Hospital, Yonsei University Health System, Seoul

135-720

Gangnam Severance Hospital, Seoul

152-703

Korea University Guro Hospital, Seoul

08003

Hospital del Mar, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

DE22 3NE

Derby Teaching Hospitals NHS FT, Derby

B15 2TH

University Hospitals Birmingham NHS Foundation Trust, Edgbaston

SE5 9RS

King's College Hospital NHS Foundation Trust, London

W21NY

Imperial College Healthcare NHS Trust, London

NE2 3HH

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

NR4 7UY

Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

PO6 3LY

Portsmouth Hospitals NHS Trust, Portsmouth

SA2 8QA

Abertawe Bro Morgannwg University Health Board, Swansea

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY