Overview

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

Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Collaborator:
Peking University People's Hospital
Treatments:
Peginterferon alfa-2a
Peginterferon alfa-2b