GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

July 31, 2013

Conditions
Hepatitis C, Chronic
Interventions
DRUG

GS-5885

"Drug: GS-5885 tablet~GS-5885 tablet, 90 mg, QD"

DRUG

GS-9451

"Drug: GS-9451 tablet~GS-9451 tablet, 200 mg QD"

DRUG

tegobuvir

tegobuvir 30 mg BID

DRUG

placebo to match tegobuvir

tegobuvir placebo BID

DRUG

placebo to match RBV

Ribovirin placebo BID

DRUG

Ribavirin

Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID

Trial Locations (51)

10021

Weill Medical College of Cornell Univeristy, New York

10029

Mount Sinai School of Medicine, New York

10467

Montefiore Medical Center, The Bronx

10969

Leber- and Studienzentrum am Checkpoint, Berlin

13353

Charite - Universitatsmedizin Berlin Campus Virchow-Klinikum, Berlin

19104

University of Pennsylvania, Philadelphia

20037

Whitman Walker Clinic, Washington D.C.

21093

Johns Hopkins University, Lutherville

21202

Mercy Medical Center, Baltimore

22589

Universitatsklinikum Hamburg-Eppendorf, Hamburg

23502

Digestive and Liver Disease Specialists, Norfolk

23602

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

24146

Gastroenterologisch-Hepatologisches Zentrum Kiel, Kiel

27599

University of North Carolina at Chapel Hill, Chapel Hill

30033

Infectious Disease Specialists of Atlanta, Decatur

30625

Medizinische Hochschule Hannover, Hanover

32720

Avail Clinical Research, LLC, DeLand

33136

University of Miami, Center for Liver Diseases, Miami

38138

Gastro One, Germantown

40237

Center for HIV and Hepatogastroenterology, Düsseldorf

48377

Henry Ford Health System, Novi

53105

Universitätsklinikum Bonn, Bonn

53792

University of Wisconsin Hospital and Clinics, Madison

55131

Johannes Gutenberg University Hospital, Mainz

60590

Klinikum der Johann Wolfgang Goethe Universitaet, Frankfurt

66160

University of Kansas Medical Center, Kansas City

69120

Klinikum der Universität Heidelberg, Heidelberg

75204

Southwest Infectious Disease Clinical Research, Inc, Dallas

77004

Therapeutic Concepts, PA, Houston

77030

The University of Texas Health Sciences Center at Houston, Houston

77555

University of Texas Medical Branch, Galveston

78215

Alamo Medical Research, Ltd., San Antonio

79106

Medizinische Universitatsklinik, Freiburg im Breisgau

81377

Klinikum Innenstadt der LMU Munchen, München

84132

University of Utah, Salt Lake City

85724

University of Arizona, Tucson

90036

Lightsource Medical, Los Angeles

90211

California Liver Institute, Beverly Hills

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

92801

Advanced Clinical Research Institute, LLC, Anaheim

94115

California Pacific Medical Center, San Francisco

95128

San Jose Gastroenterology, San Jose

97080

Universitätsklinikum Würzburg - Med Klinik und Poliklinik, Würzburg

98101

Virginia Mason Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

02905

University Gastroenterology, Providence

04103

Universitätsklinikum Leipzig, Leipzig

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY