A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in CHB
CTHBVACADCHB
1 other identifier
interventional
450
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2015
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 12, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedNovember 26, 2015
November 1, 2015
3 years
November 12, 2015
November 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hepatitis B surface Antigen （HBeAg）seroconversion
to increase Hepatitis B surface antigen (HBsAg) loss rate from 1% up to 11% or more
3 years
Secondary Outcomes (4)
Number of participants with treatment-related adverse events as assessed by low-grade fever, Infection and shock.
one and a half year
Hepatitis B envelope Antigen （HBeAg） seroconversion
3 years
HBV DNA clearance
3 years
ALT recovery
3 years
Study Arms (6)
HPDC-T cells & entecavir
EXPERIMENTALHPDC-T cells 1-5×10\^5 intravenous injection, every 2 weeks for 24 weeks , and entecavir(ETV) 0.5mg tablet by mouth, every night.
entecavir
ACTIVE COMPARATORentecavir 0.5mg tablet by mouth, every night.
HPDC-T cells & IFN-a-2a
EXPERIMENTALHPDC-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.
IFN-a-2a
ACTIVE COMPARATORIFN-a-2a 180ug subcutaneous injection， every week for 9 months.
HPDC-T cells & Telbivudine
EXPERIMENTALHPDC-T cells 1-5×10\^5 intravenous injection, every 2 weeks for 24 weeks ,and Telbivudine 600mg tablet by mouth, every night.
Telbivudine
ACTIVE COMPARATORTelbivudine 600mg tablet by mouth, every night.
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 20117267BACKGROUNDAkbar 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.
PMID: 20487261BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lubiao Chen, MD.&PHD.
The Third Affiliated Hospital of Sun Yet-sun University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- chief director of liver Lab
Study Record Dates
First Submitted
November 12, 2015
First Posted
November 26, 2015
Study Start
November 1, 2015
Primary Completion
November 1, 2018
Study Completion
November 1, 2018
Last Updated
November 26, 2015
Record last verified: 2015-11