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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Department of Infectious Disease of Wu Han Union Hospital
Wuhan, Hubei, China
RECRUITINGProportion of patients with HBsAg serological response
The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.
Time frame: at week 48 of treatment
Changes in serum HBV DNA levels
Changes in serum HBV DNA levels during 48 weeks of treatment
Time frame: at week 4，12，24，36，48，72，96 of treatment
Biochemical Response （the serum levels of ALT and AST） Biochemical Response
Biochemical response as assessed by the serum levels of ALT, AST, TB, etc.
Time frame: at week 1，2，4，8，12，16，20，24，36，48，72，96 of treatment
Proportion of patients with HBeAg serological response
The proportion of patients who achieve HBeAg serological response as assessed by the rate of HBeAg loss or HBeAg seroconversion.
Time frame: at week 48 of treatment
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