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

November 28, 2011 updated by: Cz Li

Study the Effect of Nucleoside on Host Immune in Patients With CHB

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: therapy
Drug: Telbivudine
600mg,1/d,one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy
Time Frame: base line-4 weeks-12 weeks-24 weeks-end of therapy
base line-4 weeks-12 weeks-24 weeks-end of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Decline of hepatitis B e antigen (HBeAg) level
Time Frame: base line-4weeks-12weeks-24weeks-end of therapy
base line-4weeks-12weeks-24weeks-end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cz Li

Investigators

  • Study Director: Wan Mo Bin, Professor, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

November 15, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBV20111115
  • 09zr400500 (Other Grant/Funding Number: Shanghai Natural Science Fund)
  • 30972600 (Other Grant/Funding Number: National Natural Science Foundation of China)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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