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Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B Patients

NCT01326546 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2019-06-26

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Therapeutic HBV vaccine

Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.

DRUG

entecavir

0.5mg,per day,oral intake.

OTHER

placebo

Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.

Sponsors & Collaborators

  • Third Military Medical University

    collaborator OTHER

  • Chongqing Jiachen Biotechnology Ltd.

    lead INDUSTRY

Principal Investigators

  • LanJuan Li, Ph.D. · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01326546 on ClinicalTrials.gov