NCT01140997

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

A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Ypeginterferon alfa-2b	sc, qw, for 48 weeks.
DRUG	Peginterferon alfa-2a	sc, qw, for 48 weeks.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-01-01
• Completion: 2012-03-01
• First posted: 2010-06-10
• Last updated: 2013-02-04

Locations

38 sites across 1 country: China