A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

PHASE2CompletedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

January 31, 2013

Study Completion Date

September 30, 2013

Conditions
Hepatitis C, Chronic
Interventions
DRUG

Tegobuvir (GS-9190)

Tegobuvir (GS-9190) capsule, 30 mg BID

DRUG

GS-9451

GS-9451 tablet, 200 mg once daily (QD)

BIOLOGICAL

Pegasys®

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

DRUG

Copegus®

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

DRUG

GS-9451

GS-9451 tablet, 200 mg QD

DRUG

Tegobuvir placebo

placebo matching Tegobuvir (GS-9190) capsule BID

BIOLOGICAL

Pegasys®

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

DRUG

Copegus®

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

DRUG

Tegobuvir placebo

placebo matching Tegobuvir (GS-9190) capsule BID

DRUG

GS-9451 placebo

placebo matching GS-9451 tablet QD

BIOLOGICAL

Pegasys®

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

DRUG

Copegus®

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet

Trial Locations (144)

1070

ULB Erasme, Brussels

1090

AKH der Stadt Wien, Vienna

1171

Wilhelminenspital der Stadt Wien, Vienna

1200

UCL Saint Luc, Brussels

2060

Ziekenhuis Netwerk Antwerpen, Antwerp

2650

UZ Antwerp, Edegem

4020

Krankenhaus der Elisabethinen Linz GmbH, Linz

6020

LKH Innsbruck, Innsbruck

8020

Landeskrankenhaus Graz West, Graz

8036

Medizinische Universität Graz, Graz

10016

Concorde Medical Group, New York

NYU Hepatology Associates, New York

10021

Cornell University Gastroenterology & Hepatology, New York

10029

Mount Sinai Medical Center, New York

10032

Columbia University Medical Center, New York

11030

North Shore University Hospital, Manhasset

13285

Saint Joseph Hospital, Marseille

13353

Charite University Medicine, Berlin

Leber- und Studienzentrum am Checkpoint, Berlin

13903

Binghamton Gastroenterology, Binghamton

19141

Albert Einstein Medical Center, Philadelphia

20010

Washington Hospital Center, Washington D.C.

20099

Asklepios Klinik Sankt Georg, Hamburg

21229

Digestive Disease Associates, PA, Baltimore

21287

Johns Hopkins University, Baltimore

22031

Metropolitan Research, Fairfax

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Liver Institute of Virginia, Bon Secours, Newport News

27710

Duke University Medical Center, Durham

28801

Asheville Gastroenterology Associates, P.A., Asheville

30033

Dekalb Gastroenterology, Decatur

Infectious Disease Specialists of Atlanta, Decatur

30308

Atlanta Gastroenterology Associates, Atlanta

Emory University, Infectious Disease Clinic, Atlanta

30309

Liver Center of Atlanta, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32610

University of Florida, Gainesville

32720

Avail Clinical Research, LLC, DeLand

32803

Orlando Immunology Center, Orlando

32804

Florida Hospital, Orlando

33016

Palmetto Research, Hialeah

33136

University of Miami, Miami

33161

Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research, North Miami

33414

South Florida Center of Gastroenterology, LLC, Wellington

33604

Groupe Hospitalier du Haut Leveque, Pessac

34209

Bach and Godofsky Infectious Diseases, Bradenton

36116

Alabama Liver and Digestive Specialists, Montgomery

36305

Digestive Health Specialists of the Southeast, Dothan

37203

Columbia Medical Group, The Frist Clinic, Nashville

37684

James H. Quillen VA Medical Center, Mountain Home

38138

Memphis Gastroenterology Group, Germantown

38801

Digestive Health Specialists, PA, Tupelo

39202

Gastrointestinal Associates, PA, Jackson

40202

University of Louisville, Louisville

42101

Graves Gilbert Clinic, Bowling Green

44106

University Hospitals Case Medical Center, Cleveland

45067

Centre Hospitalier Régional d'Orléans, Hôpital de la Source, Orléans

45122

University Hospital Essen, Essen

45219

Consultants for Clinical, Cincinnati

45267

University of Cincinnati, Cincinnati

46202

Indiana University, Indianapolis

46237

IGRF, Indianapolis

48377

Henry Ford Health System-Columbus center, Novi

53105

University Hospital Bonn, Bonn

53792

University of Wisconsin Hospital & Clinics, Madison

54511

Nancy University Hospital Center, Vandœuvre-lès-Nancy

55131

Johannes Gutenberg University Hospital, Mainz

55446

MN Gastroenterology, P.A., Plymouth

60590

Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt/M

60611

Northwestern Memorial Hospital, Chicago

60637

University of Chicago, Chicago

63104

Saint Louis University, St Louis

67091

Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil, Strasbourg

69004

Hôpital de la Croix Rousse, Lyon

69120

University hospital Heidelberg, Heidelberg

70809

Gastroenterology Associates, LLC, Baton Rouge

74104

Options Health Research, LLC, Tulsa

75679

Hôpital Cochin, Paris

76012

The North Texas Research Institute, Arlington

77005

Kelsey Research Foundation, Houston

77030

Advanced Liver Therapies, Houston

Research Specialists of Texas, Houston

77090

Amcare Research Inc., Houston

78215

Alamo Medical Research, San Antonio

78234

Brooke Army Medical Center, San Antonio

79106

University Hospital Freiburg, Freiburg im Breisgau

80045

University of Colorado Denver, Aurora

80110

South Denver Gastroenterology, Englewood

85054

Mayo Clinic, Phoenix

85724

University of Arizona, Tucson

87106

UNM Health Sciences Center, Albuquerque

90048

Cedars-Sinai Medical Center, Los Angeles

90211

Pacific Oaks Medical Group, Beverly Hills

91911

eStudySite, Chula Vista

91942

eStudySite, La Mesa

91950

Synergy Clinical Research Center, National City

92015

RESEARCH and EDUCATION, INC, San Diego

92037

Scripps Clinic, La Jolla

92056

eStudySite, Oceanside

92110

Beaujon Hospital, Clichy

92123

Medical Associates Research Group, San Diego

92154

Kaiser Permanente, San Diego

94010

Henri Mondor Hospital, Créteil

94115

California Pacific Medical Center, San Francisco

94121

San Francisco Veterans Affairs Medical Center, San Francisco

98101

Virginia Mason Medical Center, Digestive Disease Institute, Seattle

02114

Massachusetts General Hospital, Boston

02115

Beth Israel Deaconess Medical Center, Boston

01608

Partners in Internal Medicine, P.C., Worcester

08009

Comprehensive Clinical Research, Berlin

08844

ID Care 105, Hillsborough

07960

Atlantic Research Affiliates, LLC, Morristown

07103

University of Medicine and Dentistry of New Jersey, Newark

75390-8887

UT Southwestern Medical Center at Dallas, Dallas

Unknown

Centre Hospitalier Universitaire Sart Tilman Liège, Liège

06200

Hôpital de I´Archet 2, Service Hépatologie, Nice

04103

University Hospital Leipzig, Leipzig

1105 AZ

Academisch Medisch Centrum Universiteit Van Amsterdam, Amsterdam

6525 GA

Radaboud University Nijmegen Medical Centre (UMC St Radboud), Nijmegen

3015 GD

Erasmus University Medical Center Rotterdam, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

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 Zakład Opieki Zdrowotnej Pol-SaNa-Med Sp. z o.o.", Czeladź

25-317

Wojewodzki Szpital Zespolony w Kielcach, Kielce

31-531

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

01-201

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

02-507

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

51-149

Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego, Wroclaw

B15 2TH

Queen Elizabeth Hospital, Birmingham

L7 8XP UK

Royal Liverpool University Hospital, Liverpool

E1 2AT

Barts and The London Hospital, London

NW1 2BU

Royal Free Hospital, London

SE5 9RS

Kings College Hospital, London

SW10 9NH

Chelsea and Westminster Hospital, London

W2 1NY

Saint Mary's Hosptial, London

M13 9WL

Manchester Royal Infirmary, Manchester

M8 5RB

North Manchester General Hospital, Manchester

NG7 2UH

Nottingham University Hospitals NHS Trust, Nottingham

PL6 8DH

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY