GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

PHASE2TerminatedINTERVENTIONAL
Enrollment

248

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Chronic Hepatitis C
Interventions
DRUG

GS-5885

GS-5885 30 mg tablet administered orally once daily

DRUG

GS-9451

GS-9451 200 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

DRUG

PEG

Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Trial Locations (55)

1871

Liverpool Hospital, Sydney

2010

Saint Vincents Hospital, Darlinghurst

2050

Royal Prince Alfred Hospital, Camperdown

2137

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2747

Nepean Hospital, Kingswood

3004

Alfred Hospital, Melbourne

Monash Medical Centre, Melbourne

3050

Royal Melbourne Hospital, Parkville

3065

St. Vincent's Hospital, Sydney Ltd., Fitzroy

3081

Austin Health, Department of Hepatology, Heidelberg

3128

Box Hill Hospital, Melbourne

3240

Waikato Hospital, Hamilton

4029

Royal Brisbane Hospital Research Foundation, Herston

4102

Greenslopes Private Hospital, Woolloongabba

Princess Alexandra Hospital, Woolloongabba

5042

Flinders Medical Centre, Bedford Park

6009

Sir Charles Gairdner Hospital, Nedlands

6160

Fremantle Hospital, Fremantle

10021

Weill Cornell College of Medicine, New York

10701

Westchester Medical Center, Yonkers

11021

North Shore University Hospital, Great Neck

22031

Metropolitan Liver Diseases Center, Fairfax

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Liver Institute of Virginia, Bon Secours Health System, Newport News

27599

The University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University, Durham

28801

Asheville Gastroenterology Associates, P.A., Asheville

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

76012

The North Texas Research Institute, Arlington

77030

Research Specialists of Texas, Houston

80113

South Denver Gastroenterology, Englewood

84143

University of Utah Pediatric Pulmonology, Salt Lake City

89106

Impact Clinical Trials, Las Vegas

90036

Axis Clinical Trials, Los Angeles

90057

Axis Clinical Trials, Los Angeles

UCLA Medical Center, Los Angeles

90073

V.A. Greater Los Angeles Healthcare System, Los Angeles

92105

Research and Education, Inc., San Diego

94035

Stanford University, Stanford

95116

San Jose Gastroenterology, San Jose

95817

UC Davis Medical Center, Sacramento

97239

Oregon Health & Science University, Portland

98104

Harborview Medical Center, Seattle

02302

Commonwealth Clinical Studies, LLC, Brockton

NSW 2217

St. George Hospital, Kogarah

VIC 3011

Western Hospital, Footscray

T2N4N1

University of Calgary, Calgary

T6G 2C8

University of Alberta, Edmonton

V5Z 1H2

LAIR Centre, Vancouver

V6Z 2K5

GIRI GI Research Institute, Vancouver

R3E 3P4

University of Manitoba, John Buhler Research Centre, Winnipeg

N6A5A5

London Health Sciences, London

M6H 3M1

Toronto Liver Centre, Toronto

Unknown

Auckland Hospital, Aukland

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY