Chronic Hepatitis C, HCV Genotype 1 Clinical Trial
Official title:
Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
Open-label, single centre study evaluating efficacy and viral kinetics of combination
PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral
clearance demonstrated between 4 – 12 weeks, then randomised to further continued
combination treatment for one of three defined durations. Followed-up for 24 weeks after
treatment cessation.
Objectives:
1. To determine the necessary duration of combination treatment with Pegylated-Interferon
alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve
viral clearance
2. To identify host factors, which are associated with different patterns of virological
response to combination treatment (fast responder, slow responder, non-responder). On
this basis, to identify possible predictors for the duration of antiviral treatment.
Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will
be entered into this study. All 40 patients will be started on the same regimen of 180mg
Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in
the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who
become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into
one of three groups to continue the same antiviral regimen for an additional 3 month, 6
month or 9 month period. All these patients will subsequently be followed-up and monitored
for a further 6 months after stopping all antiviral treatment.
Treatment will be discontinued for patients who remain persistently HCV RNA positive at
treatment week 12 and they will be withdrawn from the study protocol.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment