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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.

Key facts

Study ID

NCT01054729

Run by

Gilead Sciences

People needed

64

Starts

2010-01-01

Expected to finish

2011-08-01

Last updated by the study team

2014-04-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Treatment-naive males and females, 18-65 years of age
• Genotype 1 HCV infection
• Negative pregnancy test for females of childbearing age
• Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

You may not qualify if…

• Hepatitis B or HIV infection
• Pregnant or breast feeding females or male partners of pregnant females
• Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
• History or evidence of medical condition associated with chronic liver disease other than HCV

Where it is running

• Quest Clinical Research — San Francisco, California, United States
• University of Florida — Gainesville, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Duke University — Durham, North Carolina, United States
• Alamo Medical Research Center — San Antonio, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Fundacion de Investigacion de Diego — Santurce, Puerto Rico, Puerto Rico

Full record on ClinicalTrials.gov

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