NCT01054729 - Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2010

Primary Completion Date

April 30, 2010

Study Completion Date

August 31, 2011

Conditions

Hepatitis C

Interventions

DRUG

Sofosbuvir

Sofosbuvir tablet(s) administered orally once daily

DRUG

Placebo

Placebo to match sofosbuvir administered orally once daily

DRUG

PEG

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

DRUG

RBV

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

Trial Locations (7)

27710

Duke University, Durham

32610

University of Florida, Gainesville

32803

Orlando Immunology Center, Orlando

78215

Alamo Medical Research Center, San Antonio

94115

Quest Clinical Research, San Francisco

98101

Virginia Mason Medical Center, Seattle

00909

Fundacion de Investigacion de Diego, Santurce