Overview

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

Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xiamen Amoytop Biotech Co., Ltd.
Collaborator:
Peking University First Hospital
Treatments:
Interferon-alpha
Peginterferon alfa-2a
Peginterferon alfa-2b
Criteria
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).