Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
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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.
Proportion of patients with HBeAg seroconversion at week72 [ Time Frame: 24 weeks after the cessation of treatment ]
Secondary Outcome Measures :
Proportion of Patients with HBeAg seroconversion at week 12,24,48 [ Time Frame: week 12, 24, 48 from treatment starting ]
Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72. [ Time Frame: week 4, 12, 24, 48 and 72 from treatment starting ]
Average of HBV DNA decline level at week 12, 24,48 and 72 [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]
Average of HBsAg decline level at week 12, 24, 48 and 72, and Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 12, 24, 48 and 72. [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]
Proportion of patients with ALT normalization at week 12,24, 48 and 72. [ Time Frame: week 12, 24, 48 and 72 from treatment starting ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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).