The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interferon. The trial will evaluate the effect of treatment on the progression of liver fibrosis, liver inflammation, and liver function. Treatment will be administered for up to 156 weeks with a 4-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
261
PegIFN-2b administered at a dose of 0.5 ug/kg SC once a week for 156 weeks
SNMC (as glycyrrhizin-containing compound) administered at 40 mL by intravenous (IV) injection or IV infusion 3 times weekly for 156 weeks .
Number of Participants With Change in Metavir Fibrosis Score
Metavir fibrosis score is a 5-point scale based on the amount of fibrosis in the liver, ranging from F0 (best, no fibrosis) to F4 (worst, cirrhosis).
Time frame: Baseline and discontinuation of treatment (up to 156 weeks)
Number of Participants With Alanine Aminotransferase (ALT) Normalization of >16 Weeks Duration
The ALT was judged to have been normalized when the ALT level was 35 IU/L or below.
Time frame: Week 24
Number of Participants With Change in Metavir Inflammation Score
Metavir inflammation score is a 4-point scale based on the severity of inflammation in the liver, ranging from A0 (best, no activity) to A3 (worst, severe activity).
Time frame: Baseline and Week 48
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