Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
This study is a multi-center, randomized, open-label and positive controlled Phase II
Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3
dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B
characterized by HBeAg positivity, with Pegasys 180mcg/week 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 pharmacokinetic data of Ypeginterferon
alfa-2b in hepatitis B patients to satisfy regulatory requirements.