Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B

• Status: Completed
• Trial end date: 2012-04-01
• 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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.
• Collaborator: Peking University First Hospital
• Treatments: Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• Age:18~60 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.

• Serum HBsAg positive for at least 6 months.

• Serum HBeAg positive with HBV DNA ≥20,000IU/ml.

• 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).

Exclusion Criteria:

• Pregnant or lactating women.

• Mental disorder or physical disability.

• Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.

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

• Co-infection with HAV, HIV, HCV, HDV, HEV.

• Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.

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

• Evidence of hepatic decompensation.

• History of hypothyroidism or current treatment for thyroid disease.

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