GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Chronic Genotype 1a or 1b HCV Infection
Interventions
DRUG

GS-5885 tablet

GS-5885 tablet, 90 mg, QD

DRUG

GS-9451 tablet

GS-9451 tablet, 200 mg QD

DRUG

tegobuvir capsule

tegobuvir capsule, 30 mg BID

DRUG

ribavirin tablet

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

DRUG

placebo matching ribavirin tablet

placebo matching ribavirin tablet, BID

DEVICE

placebo matching tegobuvir capsule

placebo matching tegobuvir capsule, BID

Trial Locations (50)

10021

Weill Cornell Medical College, New York

19104

University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

21093

Johns Hopkins University, Lutherville

22042

Inova Fairfax Hospital Center for Liver Diseases, Falls Church

23502

Digestive and Liver Disease Specialists, Norfolk

23602

Bon Secours St. Mary's Hospital of Richmond, Inc., Newport News

27599

University of North Carolina at Chapel Hill, Chapel Hill

28801

Asheville Gastroenterology Associates, P.A., Asheville

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

33136

University of Miami, Center for Liver Diseases, Miami

38138

Gastro One, Germantown

46237

Indianapolis Gastroenterology Research Foundation, Indianapolis

48377

Henry Ford Health System, Novi

66160

University of Kansas Medical Center, Kansas City

76012

The North Texas Research Institute, Arlington

77030

The University of Texas Health Sciences Center at Houston, Houston

77555

The University of Texas Medical Branch, Galveston

78215

Alamo Medical Research, San Antonio

80045

University of Colorado, Aurora

90027

Kaiser Permanente Medical Center, Los Angeles

90036

Lightsource Medical, Los Angeles

90211

California Liver Institute, Beverly Hills

92037

Scripps Clinic, La Jolla

92118

SCTI Research Foundation Liver Center, Coronado

92123

Medical Associates Research Group, Inc., San Diego

92154

Kaiser Permanente, San Diego

92161

University of California, San Diego, La Jolla

94115

California Pacific Medical Center, San Francisco

98101

Virginia Mason Medical Center, Seattle

32803-1851

Orlando Immunology Center (ACH), Orlando

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deconess Medical Center, Boston

01105

The Research Institute, Springfield

07102

Saint Michael's Medical Center, Newark

02905

University Gastroenterology, Providence

T2N 4Z6

University of Calgary, Calgary

T6G 2C8

University Of Alberta Hospital, Edmonton

T6G 2X8

University of Alberta, Edmonton

V5Z 1M9

Gordon & Leslie Diamond Health Care Centre, Vancouver

V6Z 2C9

University of British Columbia, Vancouver

V6Z 2K5

GIRI GI Research Institute, Vancouver

R3E 3P4

University of Manitoba, Winnipeg

N6A 5A5

London Health Sciences Centre, London

K1H 8L6

The Ottawa Hospital, Ottawa

M5G 2C4

Toronto General Hospital, University Health Network, Toronto

M5G 2N2

Toronto General Hospital, University Health Network, Toronto

M5T2S8

Toronto Western Hospital, Toronto

H2X3J4

Hospital Saint-Luc DU CHUM, Montreal

00909-1711

Clinical Research Puerto Rico Inc, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01434498 - GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection | Biotech Hunter | Biotech Hunter