Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C

Summary

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.

Timeline

Start

2010-07

Primary completion

2011-01

Completion

2012-03

Publications

• Feng B, Yang RF, Xie Q, Shang J, Kong FY, Zhang HY, Rao HY, Jin Q, Cong X, Liu YY, Kang Y, Wei L. Hepatitis C virus core antigen, an earlier and stronger predictor on sustained virological response in patients with genotype 1 HCV infection. BMC Gastroenterol. 2014 Mar 13;14:47. doi: 10.1186/1471-230X-14-47.

Drugs

Indications