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

• Status: Unknown status
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Collaborator: Shanghai Jiao Tong University School of Medicine
• Treatments: Entecavir; Interferon alpha-2; Interferon-alfa-1b; Interferon-alpha; Peginterferon alfa-2a; Telbivudine; Vaccines

Criteria

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.