This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week \& Ribavirin as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
211
sc, qw, for 48 weeks.
sc, qw, for 48 weeks.
Efficacy
Proportion of patients with HCV RNA undetectable at week 12.
Time frame: week 12
Efficacy
1. Proportion of patients with HCV RNA undetectable at Week 4, 24,48 and 72; 2. Average decline level of log10 of HCV RNA at Week 4, 12, 24, 48 and 72.
Time frame: Week 4, 12, 24, 48 and 72
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302 Military Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Beijing Youyi Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
First Affiliated Hospital of Jilin University
Changchun, China
Xiangya Hospital, Central-south University
Changsha, China
Xiangya Second Hospital, Central-south University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, China
...and 28 more locations