Conditions: Hepatitis C
Keywords: Hepatitis HCV Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 146
Healthy volunteers: no

Brief summary:
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection

Detailed description:
The aim of the study is to investigate in subjects receiving their first course of peg-interferon α-2b plus ribavirin therapy for chronic HCV infection (genotype 1) whether the addition of infliximab to a standard regimen of pegylated interferon α-2b in combination with ribavirin:

* increases the proportion of subjects attaining a sustained virological response SVR (undetectable blood Hepatitis C viral load 6 months after treatment)
* improves the safety profile compared to the same regimen without infliximab

Arms:
arm 1: Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab arm 2: Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV

Interventions: intervention 1: Infliximab intervention 2: Placebo
Intervention descriptions: intervention 1: Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46 intervention 2: Placebo

Protocol document: