Phase 2 Trial of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

NCT00869778 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2019-10-01

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) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

Conditions

Interventions

BIOLOGICAL

εPA-44

subcutaneously injection of εPA-44 at week 0, 4, 8, 12, 20, 28.

OTHER

Placebo

subcutaneously injection of Placebo at week 0, 4, 8, 12, 20, 28.

Sponsors & Collaborators

  • Third Military Medical University

    collaborator OTHER
  • Chongqing Jiachen Biotechnology Ltd.

    lead INDUSTRY

Principal Investigators

  • Lai Wei, Ph.D. · Hepatitis Institute of Peking University People's Hospital

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
2009-04-30
Primary Completion
2011-11-30
Completion
2013-05-31

Countries

  • China

Study Locations

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Entities

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 NCT00869778 on ClinicalTrials.gov