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

A Phase 3, Randomized, Multi-center, Active-controlled, Open-label Study to Evaluate the Efficacy and Safety of Peginterferon Alfa-2b (40kD, Y Shape) in Chinese Chronic Hepatitis B Patients.

This study is aimed to assess the efficacy and safety of Peginterferon alfa-2b (40kD, Y-shape), in a dose of 180μg/week, in chronic hepatitis B patients, and collects sufficient evidences for the listed of the studied drug.

Inclusion Criteria:

• Age: 18~65 years.
• Serum HBsAg or HBV DNA positive for at least 6 months.
• Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
• 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
• Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.

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.
• ANC < 1500/mm3, or PLT < 90,000/mm3.
• Co-infection with HAV, HIV, HCV, HDV, or HEV.
• Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
• Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil > 2ULN, Alb<35g/L).
• Chronic hepatitis caused by any other reason except hepatitis B.
• Hepatocarcinoma or suffering from any other malignant tumor.
• Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
• Significant function damage in any major organs (e.g.: heart, lung, kidney).
• Other Conditions which in the opinion of the investigator precluding enrollment into the study (e.g.: poor compliance).