At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 360 enrolled
Drug / intervention
εPA-44 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
In Brief
A Phase 2 clinical trial evaluating εPA-44 and Placebo for Chronic Hepatitis B. Completed, enrolled 360 participants across 15 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesChina
CollaboratorsThird Military Medical University
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2009
Enrollment StartApr 2009
Primary CompletionNov 2011
Study CompletionMay 2013
TodayJul 2026
First PostedMar 26, 2009
Enrollment StartApr 1, 2009
Primary CompletionNov 1, 2011
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.3 years ago
Interventions
εPA-44biological
subcutaneously injection of εPA-44 at week 0, 4, 8, 12, 20, 28.
Placeboother
subcutaneously injection of Placebo at week 0, 4, 8, 12, 20, 28.