Chronic Hepatitis B
Conditions
Keywords
peginterferon, HBeAg Positive, Chronic hepatitis B
Brief 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.
Interventions
sc, qw, 48 weeks.
DRUGPegasys
sc, qw, 48 weeks.
Sponsors
Peking University First Hospital
Xiamen Amoytop Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with HBeAg seroconversion at week72 | 24 weeks after the cessation of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Patients with HBeAg seroconversion at week 12,24,48 | week 12, 24, 48 from treatment starting |
| Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72. | week 4, 12, 24, 48 and 72 from treatment starting |
| Average of HBV DNA decline level at week 12, 24,48 and 72 | 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. | week 12, 24, 48 and 72 from treatment starting |
| Proportion of patients with ALT normalization at week 12,24, 48 and 72. | week 12, 24, 48 and 72 from treatment starting |
Countries
China
Outcome results
None listed