Chronic Hepatitis B
Conditions
Keywords
peginterferon, interferon, Pegasys, HBV, Hepatitis B, HBeAg positive
Brief summary
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess efficacy and safety of Ypeginterferon alfa-2b, once a week, in 3 dose-groups: 90mcg, 135mcg and 180mcg, respectively, for treatment of chronic hepatitis B characterized by HBeAg positivity, with Pegasys 180mcg/week as positive control. It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate pharmacokinetic data of Ypeginterferon alfa-2b in hepatitis B patients to satisfy regulatory requirements.
Interventions
sc, qw, for 48 weeks.
DRUGPeginterferon alfa-2a
sc, qw, for 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 60 Years
Healthy volunteers
No
Inclusion criteria
* Age:18\ 60 years. * Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment. * Serum HBsAg positive for at least 6 months. * Serum HBeAg positive with HBV DNA ≥20,000IU/ml. * 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
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. * WBC\<3000/mm3, or ANC \<1500/mm3, or PLT \<90,000/mm3. * Co-infection with HAV, HIV, HCV, HDV, HEV. * Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening. * Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease. * Evidence of hepatic decompensation. * History of hypothyroidism or current treatment for thyroid disease. * Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | week 24 from treatment start | * Average of HBV DAN decline level at week 24. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 24. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | week 12, 24, 48 from treatment start and week 24 after treatment | * Average of HBV DNA decline level at week 12, 48 and 72. * Proportion of patients with HBV DNA undetectable at week 48 and 72. * Proportion of patients with HBeAg undetectable and HBeAg seroconversion at week 48 and 72. * Proportion of patients with HBsAg undetectable and HBsAg seroconversion at week 48 and 72. * Proportion of patients with ALT normalization at week 24 and 48. |
Countries
China
Outcome results
None listed