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

PHASE3TerminatedINTERVENTIONAL
Enrollment

883

Participants

Timeline

Start Date

January 30, 2017

Primary Completion Date

May 6, 2019

Study Completion Date

May 6, 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 (283)

333

Chang Gung Medical Foundation-LinKou Branch, Taoyuan District

1023

Auckland City Hospital, Auckland

1090

Allgemeines Krankenhaus Wien, Vienna

UZ Brussel, Brussels

1200

Cliniques Universitaires UCL Saint-Luc, Brussels

2010

St. Vincent's Hospital Sydney, Darlinghurst

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

2217

St. George's Hospital, Kogarah

3000

UZ 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

3081

Austin Health, Heidelberg

3168

Monash Medical Centre, Clayton

4029

Royal Brisbane & Women's Hospital, Herston

5000

Royal Adelaide Hospital, Adelaide

5112

Lyell McEwin Hospital, Elizabeth Vale

6000

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital, Nedlands

6700

Consultorio Médico, Mexico City

6900

Istituto Cantanale di Patologia Locarno, Lugano

8003

Hospital del Mar - Parc de Salut, Barcelona

9000

Az Maria Middelares Ghent, Ghent

9016

Southern District Health Board - Dunedin Hospital, Dunedin

10002

National Taiwan University Hospital, Taipei

10003

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

10016

NYU Langone Medical Center, New York

10021

Weill Cornell Medical College, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10070

CUB Hopital Erasme, Brussels

10444

National Health Insurance Service- Ilsan Hospital, Goyang-si

10467

Montefiore Medical Center, The Bronx

11030

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

13008

Hôpital Saint Joseph, Marseille

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

17033

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

18341

Emek Medical Center, Afula

19104

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

19107

Thomas Jefferson University Hospital, Philadelphia

20089

IRCCS Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20889

Walter Reed National Military Medical Center, Bethesda

21202

Mercy Medical Center, Baltimore

21228

Digestive Disease Associates, PA, Catonsville

21742

Meritus Center for Clinical Research, Hagerstown

22042

Inova Fairfax Medical Campus, Falls Church

22332

Inha University Hospital, Incheon

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, Newport News

23249

McGuire VA Medical Center, Richmond

23298

Virginia Commonwealth University, Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

27103

Digestive Health Specialists, PA, Winston-Salem

27599

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

28204

Carolinas HealthCare System Center for Liver Disease, Charlotte

28220

Hospital Universitario Puerto de Hierro Majadahonda, Majadahonda

28304

Cumberland Research Associates LLC, Fayetteville

28677

Piedmont Healthcare, Statesville

29425

Medical University of South Carolina, University Hospital, Charleston

29605

Greenville Health System Gastroenterology and Liver Center, Greenville

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30309

Digestive Healthcare of Georgia, Atlanta

Piedmont Transplant Institute, Atlanta

31059

Centre Hospitalier Universitaire de Toulouse- Hopital Purpan, Toulouse

31096

Rambam Health Care Campus, Haifa

31201

Gastroenterology Associates of Central Georgia, LLC, Macon

31904

Columbus Regional Research Institute, Columbus

32610

University of Florida Hepatology Research at CTRB, Gainesville

32804

Florida Hospital Transplant Institute, Orlando

33030

Clinical Research of Homestead, Homestead

33136

Schiff Center for Liver Diseases/University of Miami, Miami

33157

IMIC Inc, Palmetto

33166

Integrity Clinical Research, LLC, Doral

33331

Cleveland Clinic Florida, Weston

33414

South Florida Center of Gastroenterology, PA, Wellington

33540

Florida Medical Clinic, PA, Zephyrhills

33600

Hopital Beaujon, Pessac

34211

Florida Research Institute, Lakewood Rch

34452

Nature Coast Clinical Research, Inverness

34925

CHU de Montpellier, Hopital St Eloi, Montpellier

36071

CHOP_Complejo Hospitalario Universitario de Pntevedra, Pontevedra

37211

Quality Medical Research PLLC, Nashville

37232

Vanderbilt University Medical Center - Digestive Disease Center, Nashville

37421

WR-ClinSearch, LLC, Chattanooga

38043

CHU de Grenoble- Hopital Michallon, Grenoble

38104

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

38138

Gastro One, Germantown

39008

Hospital Universitario Marques de Valdecilla, Santander

39157

Southern Therapy and Advanced Research LLC (STAR), Ridgeland

40202

University of Louisville Clinical Trials Unit, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

41707

Gastroenterology Associates of Hazard, Hazard

41931

Keimyung University Dongsan Medical Center, Daegu

44106

University Hospitals Cleveland Medical Center, Cleveland

45249

Consultants for Clinical Research, Cincinnati

45267

University of Cincinnati, Cincinnati

46014

Consorcio Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

46202

Indiana University Health - University Hospital, Indianapolis

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

48202

Henry Ford Health System, Detroit

49033

Centre Hospitalier Universitaire d'Angers, Angers

49100

Rabin Medical Center, Petah Tikva

49519

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

50325

Iowa Digestive Disease Center, P.C., Clive

52074

Uniklinik RWTH Aachen, Medizinische Klinik III, Aachen

52621

The Chaim Sheba Medical Center, Ramat Gan

53105

Universitatsklinikum Bonn (AoR), Bonn

55131

Johannes Gutenberg-Universitat, Mainz

55905

Mayo Clinic, Rochester

59037

Centre Hospitalier Regional Universitaire- Hopital Claude Huriez, Lille

60026

NorthShore University HealthSystem - Glenbrook ACC, Glenview

60590

Universitatsklinikum Frankfurt der Goethe-Universitat, Frankfurt am Main

60611

Northwestern Memorial Hospital; Clinical Research Unit, Chicago

60612

Rush University Medical Center, Chicago

60615

The University of Chicago Medical Center, Chicago

63003

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand

63104

Saint Louis University, St Louis

64000

Accelerium S. de R.L. de C.V., Monterrey

64111

Saint Luke's Hospital of Kansas City, Kansas City

64131

Kansas City Research Institute, Kansas City

64239

Shaare Zedek Medical Center, Jerusalem

Tel-Aviv Sourasky Medical Center, Tel Aviv

66160

University of Kansas Medical Center, Kansas City

67091

Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil, Strasbourg

69317

Hopital de la Croix Rousse, Lyon

70112

Tulane University Health Sciences Center, New Orleans

70121

Ocshner Medical Center, New Orleans

71021

Delta Research Partners, Bastrop

71105

Louisiana Research Center, LLC, Shreveport

72117

Arkansas Gastroenterology, North Little Rock

72204

Baptist Medical Center, Little Rock

75014

Hopital Cochin, Paris

75082

DHAT Research Institute, Richardson

75203

The Liver Institute at Methodist Dallas Medical Center, Dallas

75246

Texas Digestive Disease Consultants, Dallas

75651

Groupe Hospitalier Universitaire La Pitie Salpetriere, Paris

76012

Texas Clinical Research Institute, LLC, Arlington

77025

Kelsey-Seybold Clinic, Houston

77030

Baylor College of Medicine - Advanced Liver Therapies, Houston

Houston Methodist Hospital, Houston

Liver Associates of Texas, P.A., Houston

Research Specialists of Texas, Houston

Smith Clinic, Houston

78215

American Research Corporation, The Texas Liver Institute, San Antonio

78233

Pinnacle Clinical Research, Live Oak

78746

Pinnacle Clinical Research, PLLC, Austin

78756

Austin Center for Clinical Research, Austin

80045

University of Colorado Denver and Hospital, Aurora

80054

CHU Amiens Picardie, Amiens

80099

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

80113

South Denver Gastroenterology, PC, Englewood

84107

Intermountain Liver Disease and Transplant Clinic, Murray

84132

University of Utah, Salt Lake City

85013

St. Joseph's Hospital and Medical Center, Phoenix

85054

Mayo Clinic, Phoenix

85224

Institute of Liver Health, Chandler

87042

CHU de Limoges- Hopital Dupuytren- Federation Hepatologie, Limoges

87109

AccumetRx Clinical Research, Albuquerque

90036

Ruane Clinical Research Group, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

90073

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

91105

California Liver Research Institute, Pasadena

Huntington Medical Research Institutes (HMRI) Liver Center, Pasadena

92037

Scripps Clinical Research Services, La Jolla

92093

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

92105

Research and Education, Inc., San Diego

92118

Southern California Research Center, Coronado

92123

Medical Associates Research Group, San Diego

92377

Inland Empire Liver Foundation, Rialto

92514

Kaiser Permanente, San Diego

93003

Island View Gastroenterology Associates- Ventura, Ventura

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

eStudySite, San Francisco

94143

University of California, San Francisco-Liver Clinic, San Francisco

95817

University of California, Davis Medical Center, Sacramento

98101

Virginia Mason, Seattle

98104

Swedish Organ Transplant and Liver Center, Seattle

98195

University of Washington, Seattle

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

141001

Dayanand Medical College & Hospital, Ludhiana

160012

Department of Hepatology PGIMER Chandigarh, Chandigarh

169856

National University Health System, Singapore

Singapore General Hospital, Singapore

400012

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

440010

Midas Multispecialty Hospital, Nagpur

500004

Global Clinical Reseaech Services PVT LTD, Hyderabad

529889

Changi General Hospital Pte Ltd., Singapore

575001

Kasturba Medical College Hospital, Mangalore

600033

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

700020

Institute of Post Graduate Medical Education and Research (IPGMER), Kolkata

3436212

The Lady Davis Carmel Medical Center, Haifa

7910295

Ehime University Hospital, Tōno

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

01655

University of Massachusetts Medical School, Worcester

07102

Rutgers New Jersey Medical School- Doctors Office Center, Newark

02905

University Gastroenterology, Providence

05401

The University of Vermont Medical Center, Burlington

A-8036

Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin, Graz

T2N 4Z6

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

T5H 4B9

GI Research, Edmonton

T6G 2R3

University of Alberta, Edmonton

V5Z 1HZ

LAIR Centre, Vancouver

V5Z 1M9

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

V8T 5G4

PerCuro Clinical Research Ltd., Victoria

R3E 3P4

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

B4V 3N2

South Shore Medical Arts, Bridgewater

L6R 3J7

William Osler Health System-Brampton Civic Hospital, Brampton

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

L8S 4L8

McMaster University Medical Centre, Hamilton

N6A 5A5

London Health Sciences Centre - University Hospital, London

M5G 2C4

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

M6H 3M1

Toronto Liver Centre, 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

Universitatsklinikum Leipzig AoR, Leipzig

Unknown

Prince of Wales Hospital, Shatin

Alice Ho Miu Ling Nethersole Hospital, Tai Po

918-8503

Fukui-Ken Saiseikai Hospital, Fukui

812-8582

Kyushu University Hospital, Fukuoka

730-8619

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

410-2295

Juntendo University Shizuoka Hospital, Izunokuni

920-8641

Kanazawa University Hospital, Kanazawa

634-8522

Nara Medical University Hospital, Kashihara

105-8470

Toranomon Hospital Kajigaya, Kawasaki

Toranomon Hospital, Minato

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

480-1195

Aichi Medical University Hospital, Nagakute

630-8305

Nara City Hospital, Nara

700-8508

Kawasaki Medical School General Medical Center, Okayama

700-8558

Okayama University Hospital, Okayama

573-0153

Hirakata Kohsai Hospital, Osaka

856-8562

National Hospital Organization Nagasaki Medical Center, Ōmura

849-8501

Saga University Hospital, Saga

060-8648

Hokkaido University Hospital, Sapporo

162-8666

Tokyo Womens Medical University Hospital, Shinjuku

564-0013

Saiseikai Suita Hospital, Suita

565-0871

Osaka University Hospital, Suita

514-8507

Mie University Hospital, Tsu

990-9585

Yamagata University Hospital, Yamagata

236-0004

Yokohama City University Hospital, Yokohama

41-902

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

91-347

Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego, Lodz

41-400

ID Clinic Arkadiusz Pisula, Mysłowice

00921

Klinical Investigations Group, LLC, San Juan

VA Carribean Healthcare System, San Juan

00927

Fundacion de Investigacion de Diego, San Juan

700-721

Kyungpook National University Hospital, Daegu

463-707

Seoul National University Bundang Hospital, Seongnam

03830

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

07061

SMG-SNU Boramae Medical Center, Seoul

135-720

Gangnam Severance Hospital, Seoul

152-703

Korea University Guro Hospital, Seoul

08036

Hospital Universitario Fundacion Alcorcon, Alcorcón

Hospital Clinic de Barcelona, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

07428

National Cheng Kung University Hospital, Tainan City

G51 4TF

NHS Greater Glasgow and Clyde, Glasgow

E1 1BB

Barts Health NHS Trust, London

SE5 9RS

King's College Hospital NHS Foundation Trust, London

SW170QT

St. George's Hospital, London

W2YN1

Imperial College Healthcare NHS Trust, London

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

PL6 8DH

Plymouth Hospitals NHS Trust, Plymouth

PO6 3LY

Portsmouth Hospitals NHS Trust, Portsmouth

SA2 8QA

Abertawe Bro Morgannwg University Health Board, Swansea

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