A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

PHASE2CompletedINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

January 31, 2013

Study Completion Date

September 30, 2013

Conditions
Chronic Hepatitis C Infection
Interventions
DRUG

GS-9190

GS-9190 capsule, 20 mg BID, 16 or 24 weeks

DRUG

GS-9256

GS-9256 capsule, 150 mg BID, 16 or 24 weeks

BIOLOGICAL

Pegasys®

peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks

DRUG

Copegus®

ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks

DRUG

GS-9190 placebo

placebo matching GS-9190 capsule BID, 24 weeks

DRUG

GS-9256

GS-9256 capsule, 150 mg BID, 24 weeks

BIOLOGICAL

Pegasys®

peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks

DRUG

Copegus®

ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks

DRUG

GS-9190 placebo

placebo matching GS-9190 capsule BID, 24 weeks

DRUG

GS-9256 placebo

placebo matching GS-9256 capsule BID, 24 weeks

BIOLOGICAL

Pegasys®

peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks

DRUG

Copegus®

ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), 48 weeks

Trial Locations (114)

1070

ULB Erasme, Brussels

1090

AKH der Stadt Wien, Vienna

1171

Wilhelminenspital der Stadt Wien, Vienna

1200

UCL Saint Luc, Brussels

2060

SGS - Clinical Pharmacology Unit Antwerpen, Antwerp

2650

UZ Antwerp, Edegem

4000

CHU Sart Tilman, Liège

4020

Krankenhaus der Elisabethinen Linz GmbH, Linz

6020

LKH Innsbruck, Innsbruck

8036

Medizinische Universität Graz, Graz

10016

Concorde Medical Group, New York

10021

Cornell University Gastroenterology & Hepatology, New York

10029

Mount Sinai Medical Center, New York

10126

Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista, Torino

11021

North Shore University Hospital, Great Neck

13008

Saint Joseph Hospital, Marseille

13353

Charite University Medicine, Berlin

18012

Hospital Clínico Universitario San Cecilio, Granada

20099

Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH, Hamburg

20122

U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

21093

Johns Hopkins University, Lutherville

22031

Metropolitan Research, Fairfax

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Liver Institute of Virginia, Bon Secours, Newport News

25123

"Epatologia, Azienda Ospedaliero Spedali Civili", Brescia

27710

Duke University Medical Center, Durham

28034

Hospital Universitario Ramón y Cajal, Madrid

28222

Hospital Universitario Puerta de Hierro Majadahonda, Madrid

30308

Atlanta Gastroenterology Associates, Atlanta

Emory University, Infectious Disease Clinic, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32610

University of Florida, Gainesville

32803

Orlando Immunology Center, Orlando

33136

University of Miami Center for Liver Diseases, Miami

34243

Bach and Godofsky Infectious Diseases, Sarasota

35128

Medicina Generale - Azienda Ospedaliera di Padova, Padua

38138

Memphis Gastroenterology Group, Germantown

39090

UT Southwestern Medical Center at Dallas, Dallas

41014

Hospital Universitario Ntra. Sra. de Valme, Seville

43100

Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria, Parma

44106

University Hospitals Case Medical Center, Cleveland

45122

University Hospital Essen, Essen

46014

Hospital General Universitario de Valencia, Valencia

46202

Indiana University, Indianapolis

48202

Henry Ford Health System, Detroit

53105

University Hospital Bonn, Bonn

54500

Nancy University Hospital Center, Vandœuvre-lès-Nancy

55131

Johannes Gutenberg University Hospital, Mainz

59000

Claude Huriez Hospital, Lille

60590

Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt/M

60611

Northwestern Memorial Hospital, Chicago

69002

Hotel Dieu Hospital, Lyon

69120

University hospital Heidelberg, Heidelberg

70809

Gastroenterology Associates, LLC, Baton Rouge

76012

The North Texas Research Institute, Arlington

78215

Alamo Medical Research, San Antonio

79106

University Hospital Freiburg, Freiburg im Breisgau

80110

South Denver Gastroenterology, Englewood

81377

Ludwig-Maximilians-University Munich, München

85054

Mayo Clinic, Phoenix

87505

Southwest CARE Center, Santa Fe

90048

Cedars-Sinai Medical Center, Los Angeles

90127

U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone, Palermo

92037

Scripps Clinic, La Jolla

92110

Beaujon Hospital, Clichy

92123

Medical Associates Research Group, San Diego

92154

Kaiser Permanente, San Diego

92801

Advanced Clinical Research Institute, Anaheim

94000

Henri Mondor Hospital, Créteil

94115

California Pacific Medical Center, San Francisco

98101

Virginia Mason Medical Center, Digestive Disease Institute, Seattle

02115

Beth Israel Deaconess Medical Center, Boston

02905

University Gastroenterology, Providence

T2N 4N1

Heritage Medical Research Clinic, Calgary

T6G 2C2

University of Alberta, Division of Gastroenterology, Edmonton

V3S 4N9

Downtown ID Clinic, Vancouver

V5Z 3P1

Gordon & Leslie Diamond Health Care Centre, Vancouver

V6Z 2K5

GI Research Institute, Vancouver

R3E 3P4

John Buhler Research Centre, Winnipeg

N6A 5A5

London Health Sciences Centre, London

K1H 8L6

Ottawa Hospital, Division of Infectious Diseases, Ottawa

M5G 2C4

Toronto General Hospital, Toronto

M5T 2S8

Toronto Western Hospital, Toronto

625 00

University Hospital Brno, Brno

276 01

Melnik Hospital, Mělník

304 60

University Hospital Plzen, Pilsen

128 00

Klinmed, s.r.o., Prague

140 21

Institute of Clinic and Experimental Medicine, Prague

477 01

Association of Physicians for Infection Diseases, Ústí nad Labem

04103

University Hospital Leipzig, Leipzig

15-540

Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny, Bialystok

85-030

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny, Bydgoszcz

41-500

Szpital Specjalistyczny w Chorzowie, Chorzów

41-250

"Niepubliczny Zaklad Opieki Zdrowotnej Pol-SaNa-Med Spolka z ograniczona odpowiedzialnoscia", Czeladź

25-736

Wojewodzki Szpital Zespolony w Kielcach, Kielce

31-501

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow

91-347

Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi, Lodz

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin

26-610

Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby, Radom

71-455

Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie, Szczecin

01-201

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny, Warsaw

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X, Warsaw

02-507

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Warsaw

50-220

EMC Instytut Medyczny S.A., Wroclaw

08035

Hospital Universitari Vall d'Hebrón, Barcelona

B15 2TH

Queen Elizabeth Hospital, Birmingham

M8 5RB

North Manchester General Hospital, Greater Manchester

L7 8XP UK

Royal Liverpool University Hospital, Liverpool

E1 2AT

Barts and The London Hospital, London

NW1 2BU

University College London Hospital, London

SE5 9RS

Kings College Hospital, London

SW109NH

Chelsea and Westminster Hospital, London

NE24HH

Institute of Cellular Medicine (Hepatology), Newcastle upon Tyne

PL6 8DH

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY