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Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection

NCT ID: NCT01480492

Last Updated: 2011-11-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-10-31

Brief Summary

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During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.

Detailed Description

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Conditions

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HBeAg Positive Chronic Hepatitis B Infection

Keywords

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HBV Immune antiviral therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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therapy

Group Type NO_INTERVENTION

Telbivudine

Intervention Type DRUG

600mg,1/d,one year

Interventions

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Telbivudine

600mg,1/d,one year

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-65 years old
* chronic HBV infection
* HBeAg positive,HBV DNA more than 10E5 IU/mL
* ALT ≥2×UTL

Exclusion Criteria

* with liver cancer
* with liver failure
* pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cz Li

OTHER

Sponsor Role lead

Responsible Party

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Cz Li

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wan Mo Bin, Professor

Role: STUDY_DIRECTOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Li CZ, Hu JJ, Xue JY, Yin W, Liu YY, Fan WH, Xu H, Liang XS. Viral infection parameters not nucleoside analogue itself correlates with host immunity in nucleoside analogue therapy for chronic hepatitis B. World J Gastroenterol. 2014 Jul 28;20(28):9486-96. doi: 10.3748/wjg.v20.i28.9486.

Reference Type DERIVED
PMID: 25071343 (View on PubMed)

Other Identifiers

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09zr400500

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

30972600

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HBV20111115

Identifier Type: -

Identifier Source: org_study_id