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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBeAg(+):Poly IC+Entecavir | Experimental | 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 |
|
| HBeAg(+):Entecavir | Active Comparator | 45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. |
|
| HBeAg(-):Poly IC+Entecavir | Experimental | 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 |
|
| HBeAg(-):Entecavir | Active Comparator | 45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly IC | Drug | Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Zheng, M.D. | Contact | (00)-86-02785726732 | zheng2015uh@163.com | |
| Jin Tian, M.S. | Contact | (00)-86-02785726132 | tjxhtj@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liang D Yang, M.D. | Huanzhong University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Infectious Disease of Wu Han Union Hospital | Recruiting | Wuhan | Hubei | 430022 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011070 | Poly I-C |
| C413685 | entecavir |
| ID | Term |
|---|---|
| D011066 | Poly C |
| D011131 | Polyribonucleotides |
| D011119 | Polynucleotides |
| D009711 | Nucleotides |
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|
| Entecavir | Drug | Entecavir can inhibit the replication of HBV. |
|
|
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 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009706 |
| Nucleic Acids, Nucleotides, and Nucleosides |
| D011069 | Poly I |