Study in Naive G1 & G4 Hep C Patients with Triple Combo vs SOC/Ver 1.0
Research type
Research Study
Full title
A Randomized, Double-blinded, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug (RO5024048) in Combination with Pegasys® and Copegus® versus the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection
IRAS ID
17021
Contact name
William Rosenberg
Contact email
Sponsor organisation
F Hoffman-La Roche Ltd Basel
Eudract number
2008-008258-21
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
Hepatitis C (HCV) is a viral infection which can lead to liver disease, liver failure and death. All participants on this study will have a particular form of the virus known as genotype 1 or genotype 4.
The current approved standard treatment for patients infected with HCV is a combination of two drugs called Pegylated Interferon (e.g. Pegasys) and Ribavirin (e.g. Copegus) taken for 48 weeks. This study is investigating whether a new drug called the HCV Polymerase Inhibitor Prodrug, when taken additionally to Pegasys and Copegus in triple combination, will be more effective in achieving a sustained undetectable level of the virus in the blood than Pegasys and Copegus alone.
Participants who agree to take part in the study will be randomly assigned to one of 5 treatment groups. 4 out of 5 of these treatment groups will involve taking triple combination therapy with a different dose and duration depending on which group they are assigned to. The final group will receive the standard approved treatment of Pegasys and Copegus alone.
The effects of the HCV Polymerase Inhibitor Pro drug on the viral load will be monitored carefully at the clinic visits. All participants will be followed up for safety after treatment for 24 weeks.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
09/H0803/51
Date of REC Opinion
12 May 2009
REC opinion
Further Information Favourable Opinion