Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B
NCT ID: NCT02532413
Last Updated: 2015-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2015-07-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HBeAg(+):Poly IC+Entecavir
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
Poly IC
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Entecavir
Entecavir can inhibit the replication of HBV.
HBeAg(+):Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Entecavir
Entecavir can inhibit the replication of HBV.
HBeAg(-):Poly IC+Entecavir
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
Poly IC
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Entecavir
Entecavir can inhibit the replication of HBV.
HBeAg(-):Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Entecavir
Entecavir can inhibit the replication of HBV.
Interventions
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Poly IC
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Entecavir
Entecavir can inhibit the replication of HBV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having been treated wit Entecavir and the level of HBV DNA is under 1000 copies/ml.
* ALT ≤10×ULN， TB \<2ULN .
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Xin Zheng
Professor
Principal Investigators
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Liang D Yang, M.D.
Role: STUDY_CHAIR
Huanzhong University of Science and Technology
Locations
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Department of Infectious Disease of Wu Han Union Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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81461130019C5
Identifier Type: -
Identifier Source: org_study_id
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