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A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB

NCT02615639 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2015-11-26

No results posted yet for this study

Summary

The anti-virus effects is not satisfying in some of Chronic Hepatitis B（CHB) patients who have been on anti-Hepatitis B Virus (HBV) drugs therapy. Dendritic cell (DC) is critical in Hepatitis B Virus (HBV) specific immunity in the process of producing HBV promoter specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs), however they are defective in CHB patients. Therefore, if it were going to remove HBV completely, it mainly depends if the body itself can produce enough HBV specific cytotoxic T cells (CTLs) and specific T helper cells (HTLs). Our research is to plus Hepatitis B Vaccine Activated-DCs therapy to CHB patients who have been on anti-HBV drugs but with poor effects, supposing to significantly improve anti-HBV efficacy, even to clean HBV from the patients.

Conditions

Interventions

BIOLOGICAL

HPDC-T cells & Entecavir

experimental groups will be given HPDC-T cells \& Entecavir. HPDC-T cells will be given for 24weeks on the basis of anti-HBV therapy ,and entecavir 0.5mg tablet every night by mouth

DRUG

Entecavir

0.5mg tablet every night by mouth

DRUG

HPDC-T cells & IFN-a-2a

experimental groups will be given HPDC-T cells \& IFN-a-2a. HPDC-T cells will be given for 24 weeks on the basis of anti-HBV therapy ,and IFN-a-2a 180ug subcutaneous injection every week

DRUG

IFN-a-2a

IFN-a-2a 180ug subcutaneous injection every week

DRUG

HPDC-T cells & Telbivudine

experimental groups will be given HPDC-T cells \& Telbivudine. HPDC-T cells will be given for 24weeks on the basis of anti-HBV therapy ,and Telbivudine 600mg tablet every day by mouth

DRUG

Telbivudine

Telbivudine 600mg tablet every day by mouth

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Lubiao Chen, MD.&PHD. · The Third Affiliated Hospital of Sun Yet-sun University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-11-30
Completion
2018-11-30

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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 NCT02615639 on ClinicalTrials.gov