Chronic Hepatitis B
Conditions
Brief summary
The purpose of this study is to investigate antiviral efficacy of the combination treatment with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for chronic hepatitis B.
Detailed description
In this study, the patients with chronic HBV infection will be divided into two groups: HBeAg (+) and HBeAg (-) group. Each group will be divided into two subgroups, which are treated with combination treatment of Entecavir and Poly IC and Entecavir monotherapy respectively. All the patients will be followed up for one year. From this study, the investigators want to study if Poly IC can enhance antiviral efficacy of Entecavir for chronic hepatitis B.
Interventions
DRUGPoly IC
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
DRUGEntecavir
Entecavir can inhibit the replication of HBV.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
* HBsAg positive for more than 6 months. * Having been treated wit Entecavir and the level of HBV DNA is under 1000 copies/ml. * ALT ≤10×ULN， TB \<2ULN .
Exclusion criteria
* Previous antiviral treatment for HBV. * Co infection of HIV, HCV, HEV, HAV, or HAV. * Evidence of hepatic carcinoma. * Evidence of autoimmune disease. * Evidence of thyroid disease. * History of mental sickness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with HBsAg serological response | at week 48 of treatment | The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in serum HBV DNA levels | at week 4，12，24，36，48，72，96 of treatment | Changes in serum HBV DNA levels during 48 weeks of treatment |
| Biochemical Response （the serum levels of ALT and AST） Biochemical Response | at week 1，2，4，8，12，16，20，24，36，48，72，96 of treatment | Biochemical response as assessed by the serum levels of ALT, AST, TB, etc. |
| Proportion of patients with HBeAg serological response | at week 48 of treatment | The proportion of patients who achieve HBeAg serological response as assessed by the rate of HBeAg loss or HBeAg seroconversion. |
Countries
China
Contacts
Primary ContactXin Zheng, M.D.
Backup ContactJin Tian, M.S.
Outcome results
None listed