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Trial record 14 of 373 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified November 2015 by Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Collaborator:
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02615639
First received: November 12, 2015
Last updated: November 24, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Chronic Hepatitis B Biological: HPDC-T cells & Entecavir Drug: Entecavir Drug: HPDC-T cells & IFN-a-2a Drug: IFN-a-2a Drug: HPDC-T cells & Telbivudine Drug: Telbivudine Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial on Hepatitis B Vaccine Activated-Dendritic Cells Combined With Anti-HBV Drugs in Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • Hepatitis B surface Antigen (HBeAg)seroconversion [ Time Frame: 3 years ]
    to increase Hepatitis B surface antigen (HBsAg) loss rate from 1% up to 11% or more


Secondary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by low-grade fever, Infection and shock. [ Time Frame: one and a half year ]
    Safety profiles include side effects of anti-HBV drugs(ETV,LDT and IFN-a), viral resistance of anti-HBV drugs. And side effects of HPDC-T cells infusion,such as low-grade fever, Infection and shock.The difference of side effects rates between anti-HBV drugs monotherapy and anti-HBV drugs plus HPDC-T cells combined therapy will also be analyzed.

  • Hepatitis B envelope Antigen (HBeAg) seroconversion [ Time Frame: 3 years ]
    to increase HBeAg negative rate by 12 percentage points on the basis of the existing data

  • HBV DNA clearance [ Time Frame: 3 years ]
    to increase the undetectable rate of HBV DNA

  • ALT recovery [ Time Frame: 3 years ]
    to increase the recovery rate of ALT


Estimated Enrollment: 450
Study Start Date: November 2015
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Other Name: Hepatitis B Vaccine Activated-DCs & Entecavir
Active Comparator: entecavir
entecavir 0.5mg tablet by mouth, every night.
Drug: Entecavir
0.5mg tablet every night by mouth
Other Name: Baraclude
Experimental: 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.
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
Other Name: Hepatitis B Vaccine Activated-DCs & Pegasys
Active Comparator: IFN-a-2a
IFN-a-2a 180ug subcutaneous injection, every week for 9 months.
Drug: IFN-a-2a
IFN-a-2a 180ug subcutaneous injection every week
Other Name: Pegasys
Experimental: 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.
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
Other Name: Hepatitis B Vaccine Activated-DCs & Telbivudine
Active Comparator: Telbivudine
Telbivudine 600mg tablet by mouth, every night.
Drug: Telbivudine
Telbivudine 600mg tablet every day by mouth
Other Name: LDT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02615639

Contacts
Contact: Yurong Gu, MD. 18588628204 ext +86 guyr163@163.com
Contact: Yuehua Huang, MD.&PHD. 18922103516 ext +86 huangyh53@mail.sysu.edu.cn

Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Lubiao Chen, MD.&PHD. The Third Affiliated Hospital of Sun Yet-sun University
  More Information

Publications:
Responsible Party: Yuehua Huang, chief director of liver Lab, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02615639     History of Changes
Other Study ID Numbers: SunYatSenIDD
Study First Received: November 12, 2015
Last Updated: November 24, 2015

Keywords provided by Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University:
HPDC-T cells
CHB
immuno therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Interferon-alpha
Peginterferon alfa-2a
Entecavir
Telbivudine
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017