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A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis B

NCT01189656 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2010-08-27

No results posted yet for this study

Summary

To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next dosing regimen.

Conditions

  • Chronic Hepatitis B Patients With HBeAg-positive

Interventions

BIOLOGICAL

HBV DNA Vaccine

HBV DNA Vaccine, 1mg/ml/syringe, formulation

Sponsors & Collaborators

  • Guangzhou Baidi Biotechnology Co., Ltd

    collaborator UNKNOWN

  • Guangzhou Pharmaceucal Company Limited

    collaborator UNKNOWN

  • The 458 Hospital of Chinese PLA

    lead OTHER

Principal Investigators

  • Yu Yanyan, Professor · SFDA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-11-30
Completion
2010-12-31

Countries

  • China

Study Locations

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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 NCT01189656 on ClinicalTrials.gov