Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy and safety of Peginterferon alfa-2b
(40KD, Y shape, the followings will refer as Ypeginterferon alfa-2b for short), at a dose of
180μg/week, in combination with Ribavirin in Chinese chronic hepatitis C patients. The study
will first group patients into two sub-study, genotype 2/3 and non-genotype 2/3, depending on
the HCV genotype that infected. In the genotype 2/3 sub-study about 219 patients will be
enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group
or active control group (Pegasys), receiving 24 weeks of interferon therapy and oral daily
Ribavirin at a dose of 800mg/d. In the non-genotype 2/3 sub-study about 507 patients will be
enrolled, and eligible patients are randomized at 2:1 ratio into Ypeginterferon alfa-2b group
or active control group (Pegasys), receiving 48 weeks of interferon therapy and oral daily
Ribavirin 1000-1200mg/day , basing on body weight. All patients will be followed for 24 weeks
after the end of therapy.