Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

PHASE2TerminatedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

December 5, 2012

Primary Completion Date

August 2, 2016

Study Completion Date

December 29, 2016

Conditions
Liver Fibrosis Due to NASH
Interventions
BIOLOGICAL

Placebo

Placebo to match SIM via subcutaneous injection every week

BIOLOGICAL

SIM

Subcutaneous injection every week

Trial Locations (68)

152

Azienda Ospedaliera San Camillo Forlanini, Roma

1070

Hôpital Erasme, Brussels

1200

Université Catholique de Louvain, Brussels

4103

EUGASTRO GmbH, Leipzig

10021

Weill Cornell Medical College, New York

10029

Mount Sinai Hospital, New York

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino

14203

State University Of New York, Buffalo

19104

University of Pennsylvania, Philadelphia

20080

Hospital Donostia, Donostia / San Sebastian

20889

Walter Reed National Military Medical Center, Bethesda

21202

Mercy Medical Center, Baltimore

22908

University of Virginia Health System, Charlottesville

23229

Bucheon St. Marys Hospital, Richmond

23298

Virginia Commonwealth University Health System, Richmond

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Liver Institute of Virginia, Newport News

24146

Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel

27710

Duke University, Durham

28222

Hospital Universitario Puerta de Hierro, Majadahonda

29425

Medical University of South Carolina, Charleston

30625

Medizinische Hochschule Hannover, Hanover

33136

Miami Veterans Administration Healthcare System, Miami

33606

Tampa General Hospital, Tampa

39216

University of Mississippi Medical Center, Jackson

40202

University of Louisville, Louisville

41100

Azienda Ospedaliero-Universitaria di Modena Policlinico, Modena

44106

University Hospitals Case Medical Center, Cleveland

44195

Cleveland Clinic, Cleveland

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

48109

University of Michigan, Ann Arbor

50325

Iowa Digestive Disease Center, Clive

55114

Minnnesota Gastroenterology, PA, Saint Paul

60611

Northwestern University, Chicago

63110

Saint Louis University Hospital, St Louis

67091

CHU Strasbourg Hôpital Civil, Strasbourg

70112

Tulane University, New Orleans

75012

Hospital Saint-Antoine, Paris

75013

Groupe Hospitalier Pitié- Salpétrière, Paris

76012

Texas Clinical Research Institute, LLC, Arlington

77030

St. Luke's Episcopal Hospital, Houston

78215

Alamo Clinical Research Associates, San Antonio

78234

Brooke Army Medical Center, Fort Sam Houston

80045

University of Colorado, Aurora

84132

University of Utah, Salt Lake City

85054

Mayo Clinic Hospital, Phoenix

92103

University of California, San Diego (UCSD), San Diego

92110

Hopital Beaujon, Clichy

92118

Southern California Liver Centers, Coronado

94143

University of California San Francisco (UCSF), San Francisco

98101

Virginia Mason Medical Center, Seattle

98104

University of Washington, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

01805

Lahey Clinic, Burlington

02905

University Gastroenterology, Providence

B-9000

UZ Ghent, Ghent

T2N 4Z6

University of Calgary, Calgary

R3E 3P4

University of Manitoba, Winnipeg

N6A 5A5

London Health Science Center, London

M6H 3M1

Toronto Liver Centre, Toronto

00927

Fundacion De Investigacion, San Juan

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

OX3 9DU

John Radcliffe Hospital, Headington

E1 1BB

The Royal London Hospital, London

NW3 2QG

Royal Free Hospital, Pond Street, London

SE5 9RS

King's College Hospital NHS Foundation Trust No. 1 Account, London

NG7 2UH

Nottingham University Hospitals Queens Medica, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY