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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Collaborator: Peking University People's Hospital
• Treatments: Peginterferon alfa-2a; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

• Age: 18~65 years.

• Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.

• Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C.

• HCV RNA≥2000IU/ml.

Exclusion Criteria:

• Pregnant or lactating women.

• Mental disorder or physical disability.

• WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.

• Received interferon treatment within the previous 6 months or shew no response to interferon.

• Co-infection with HIV, HAV, HBV, HEV.

• Evidence of hepatic decompensation.

• Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.

• History of hypothyroidism or current treatment for thyroid disease.

• Diabetes mellitus.

• Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.