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

Xiamen Amoytop Biotech

Status and phase

Completed

Phase 3

Conditions

Chronic Hepatitis B

Treatments

Drug: Pegasys

Drug: Ypeginterferon alfa-2b

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01760122

TB1211IFN

Details and patient eligibility

About

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.

Enrollment

820 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).