Status and phase
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About
The purpose is to evaluate efficacy and safety of therapeutic Hepatitis B Virus(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.
Full description
First stage(0-76 weeks):
Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio:
The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76).
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):
The definition of response is defined as below:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
360 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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