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

NCT ID: NCT02615639

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-11-30

Brief Summary

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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.

Detailed Description

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Patients who have been on anti-HBV therapy Complying with the inclusion criteria will be enrolled into our research, Nucleoside analogues (NAs,entecavir） treatment for more than 1 year or interferon（IFN)-a-2a (IFN-a-2a,Pegasys） treatment for more than 24 weeks. The patients will be randomly assigned to experimental group and control group with the ratio of 2:1, one group (control group) will go on receive the anti-HBV drugs treatment solely; another group (experimental group) after enrollment will immediately receive the Hepatitis B Vaccine activated-DCs (HPDC-T cells) for 24 weeks (every 2 weeks once for 24 weeks, 12 times in total), at the same time co-use anti-HBV drugs treatment, as for Pegasys, it will go on to be used for 12 weeks after HPDC-T cells treatment completed.

The technical route of HBV-T cells prepared: First, investigators collect fresh blood of CHB, mononuclear cells were isolated, and induced to HBsAg pulsed DCs in Hepatitis B vaccine (Shenzhen kangtai, Shenzhen, China) and interleukin-4（IL-4)/granulocyte-macrophage colony-stimulating factor(GM-CSF） (Perprotech, New Jersey, USA) (7 days), then co-culture of DCs and Peripheral Blood Mononuclear Cell(PBMCs ）7days, obtain HBV specific T cells, return to the patient finally.

Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HPDC-T cells & entecavir

HPDC-T cells 1-5×10\^5 intravenous injection, every 2 weeks for 24 weeks , and entecavir(ETV) 0.5mg tablet by mouth, every night.

Group Type EXPERIMENTAL

HPDC-T cells & Entecavir

Intervention Type BIOLOGICAL

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

entecavir

entecavir 0.5mg tablet by mouth, every night.

Group Type ACTIVE_COMPARATOR

Entecavir

Intervention Type DRUG

0.5mg tablet every night by mouth

HPDC-T cells & IFN-a-2a

HPDC-T cells 1-5×10\^5 intravenous injection, every 2 weeks for 24 weeks ,and IFN-a-2a 180ug subcutaneous injection， every week for 9 months.

Group Type EXPERIMENTAL

HPDC-T cells & IFN-a-2a

Intervention Type DRUG

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

IFN-a-2a

IFN-a-2a 180ug subcutaneous injection， every week for 9 months.

Group Type ACTIVE_COMPARATOR

IFN-a-2a

Intervention Type DRUG

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

HPDC-T cells & Telbivudine

HPDC-T cells 1-5×10\^5 intravenous injection, every 2 weeks for 24 weeks ,and Telbivudine 600mg tablet by mouth, every night.

Group Type EXPERIMENTAL

HPDC-T cells & Telbivudine

Intervention Type DRUG

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

Telbivudine

Telbivudine 600mg tablet by mouth, every night.

Group Type ACTIVE_COMPARATOR

Telbivudine

Intervention Type DRUG

Telbivudine 600mg tablet every day by mouth

Interventions

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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

Intervention Type BIOLOGICAL

Entecavir

0.5mg tablet every night by mouth

Intervention Type 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

Intervention Type DRUG

IFN-a-2a

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

Intervention Type 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

Intervention Type DRUG

Telbivudine

Telbivudine 600mg tablet every day by mouth

Intervention Type DRUG

Other Intervention Names

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Hepatitis B Vaccine Activated-DCs & Entecavir Baraclude Hepatitis B Vaccine Activated-DCs & Pegasys Pegasys Hepatitis B Vaccine Activated-DCs & Telbivudine LDT

Eligibility Criteria

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Inclusion Criteria

* chronic hepatitis B patients, aged 18\~65，Chinese
* have been on entecavir（ETV） or telbivudine（LDT） treatment for more than 1 year,and HBV DNA\<100 IU/ml（Roche Cobas）;or have been on
* have been on PEG-IFN treatment for more than 24 weeks,and 20 \< HBV DNA \< 20000 IU/ml（Roche Cobas）.
* HBsAg 100\~5000 IU/ml
* HBeAg 10\~500 COI

Exclusion Criteria

* Superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
* other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
* ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
* liver cirrhosis (including compensated and decompensated cirrhosis) and liver failure;
* severe bacterial or fungal infections;
* a history of diabetes or cardiac disease or hypertension or nephrosis;
* pregnant women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Yuehua Huang

chief director of liver Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lubiao Chen, MD.&PHD.

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated Hospital of Sun Yet-sun University

Central Contacts

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Yurong Gu, MD.

Role: CONTACT

[email protected]
18588628204 ext. +86

Yuehua Huang, MD.&PHD.

Role: CONTACT

[email protected]
18922103516 ext. +86

References

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Luo J, Li J, Chen RL, Nie L, Huang J, Liu ZW, Luo L, Yan XJ. Autologus dendritic cell vaccine for chronic hepatitis B carriers: a pilot, open label, clinical trial in human volunteers. Vaccine. 2010 Mar 16;28(13):2497-504. doi: 10.1016/j.vaccine.2010.01.038. Epub 2010 Jan 29.

Reference Type BACKGROUND
PMID: 20117267 (View on PubMed)

Akbar SM, Furukawa S, Horiike N, Abe M, Hiasa Y, Onji M. Safety and immunogenicity of hepatitis B surface antigen-pulsed dendritic cells in patients with chronic hepatitis B. J Viral Hepat. 2011 Jun;18(6):408-14. doi: 10.1111/j.1365-2893.2010.01320.x.

Reference Type BACKGROUND
PMID: 20487261 (View on PubMed)

Other Identifiers

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SunYatSenIDD

Identifier Type: -

Identifier Source: org_study_id