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Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients

Clinical Trial Summary

The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

Clinical Trial Description

Second stage(76-144 weeks):

In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks)

1. Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128.

2. Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.

The definition of response as below:

1. Virological response: HBV DNA＜2.93×10∧3IU/ml at 76 weeks;

2. Serological response: serological conversion of HBeAg at 76 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02862106
Study type Interventional
Source Chongqing Jiachen Biotechnology Ltd.
Contact
Status Completed
Phase Phase 2
Start date September 2010
Completion date March 2013
View Details
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