Chronic Hepatitis C Clinical Trial
Official title:
A Phase III Study of Ro25-8310 (Peginterferon Alfa-2a) in Combination With Ro20-9963 (Ribavirin) in Patients With Chronic Hepatitis C
This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a
plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with
peginterferon alfa-2a monotherapy.
Additionally, the study evaluated the efficacy and safety of the combination of
peginterferon alfa-2a plus ribavirin in patients with CHC who had failed to respond to
previous conventional-interferon based therapy.
Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind
treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a
(40KD) plus either twice-daily oral ribavirin (600 to 1000mg/day) or placebo.
All patients who had received previous treatment with conventional interferon but had failed
to respond (no suppression of HCV-RNA below detection limits of a sensitive assay) or had
relapsed (reversion to HCV-RNA positive state after suppression) received the combination of
peginterferon alfa-2a (40KD) plus ribavirin for 48 weeks at the dosages stated above.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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