Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Poly IC
* Drug: Entecavir


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HBeAg(+):Poly IC+Entecavir<br>45 subjects(HBeAg-positive chronic hepatitis B). Combination therapy will last 24 weeks from 0 week. Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week | Drug: Poly IC<br>* Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.<br>* Other names: Polyinosinic-polycytidylic acid injection;Drug: Entecavir<br>* Entecavir can inhibit the replication of HBV.<br>* Other names: Leiyide;|
| Active Comparator: HBeAg(+):Entecavir<br>45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. | Drug: Entecavir<br>* Entecavir can inhibit the replication of HBV.<br>* Other names: Leiyide;|
| Experimental: HBeAg(-):Poly IC+Entecavir<br>45 subjects(HBeAg-negative chronic hepatitis B). Combination treatment will last 24 weeks from 0 week. Drug: Enticavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week | Drug: Poly IC<br>* Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.<br>* Other names: Polyinosinic-polycytidylic acid injection;Drug: Entecavir<br>* Entecavir can inhibit the replication of HBV.<br>* Other names: Leiyide;|
| Active Comparator: HBeAg(-):Entecavir<br>45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. | Drug: Entecavir<br>* Entecavir can inhibit the replication of HBV.<br>* Other names: Leiyide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with HBsAg serological response | The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion. | at week 48 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum HBV DNA levels | Changes in serum HBV DNA levels during 48 weeks of treatment | 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. | 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. | at week 48 of treatment |