At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 378 enrolled
Drug / intervention
Therapeutic HBV vaccine +2 morebiological
Likely dose
Therapeutic HBV vaccine 900μgfrom 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 Randomized, Double-blind, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating HBeAg Positive Chronic Hepatitis B Patients
In Brief
A Phase 2 clinical trial evaluating Therapeutic HBV vaccine, entecavir, and 1 other intervention for Chronic Hepatitis B. Completed, enrolled 378 participants across 15 sites.
Detailed Summary
The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesChina
CollaboratorsThird Military Medical University
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedMar 2011
Primary CompletionJan 2014
TodayJul 2026
First PostedMar 31, 2011
Enrollment StartJun 1, 2010
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.3 years ago
Interventions
Therapeutic HBV vaccinebiological
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
entecavirdrug
0.5mg,per day,oral intake.
placeboother
Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.