Trial record 140 of 435 for:    hepatitis b | Open Studies

A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Collaborators:
Ruijin Hospital
The second people's hospital of yunnan province
Information provided by (Responsible Party):
Yuehua Huang, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01935635
First received: September 1, 2013
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic hepatitis B patients


Condition Intervention Phase
Chronic Hepatitis B
Antiviral Agents
Dendritic Cells
Biological Therapy
Biological: HPDCs-T immune therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial on Hepatitis B Vaccine Activated-DCs Combined With Peg-interferon or Nucleotide Analogs in Chronic Hepatitis B

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HBV makers [ Time Frame: 01/01/2014-31/12/2016, total 6 times (3 years) ] [ Designated as safety issue: No ]
    HBV DNA loads,HBsAg/HBsAb titer,HBeAg/HBeAb titer


Secondary Outcome Measures:
  • Coagulation tests [ Time Frame: 01/01/2014-31/12/2016, total 6 times (3 years) ] [ Designated as safety issue: No ]
    PT,PTA,INR

  • liver function [ Time Frame: 01/01/2014-31/12/2016, total 6 times (3 years) ] [ Designated as safety issue: No ]
    ALT,AST,Tbil,Alb

  • alpha-fetal protein [ Time Frame: 01/01/2014-31/12/2016, total 4 times (3 years) ] [ Designated as safety issue: Yes ]
    AFP;Biomarkers of hepatocellular carcinoma,one time every 24 weeks

  • B ultrasound or MRI examination of the liver [ Time Frame: 01/01/2014-31/12/2016, total 2 times (3 years) ] [ Designated as safety issue: Yes ]
    The examination is performed both at the end of the pre-experiment and the main experiment

  • Liver biopsy [ Time Frame: 01/01/2014-31/12/2016, total 2 times (3 years) ] [ Designated as safety issue: No ]
    The examination is performed both before and during experiment.


Estimated Enrollment: 450
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HPDCs-T combined with IFN
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2*105-1*106 cells per time,total 12 times; IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks
Biological: HPDCs-T immune therapy
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2*105-1*106 cells per time,total 12 times;
Other Names:
  • The HBsAg sensitized dendritic cells activated T cells
  • HBsAg Pulse DCs-T
Experimental: HPDCs-T combined with ETV
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2*105-1*106 cells per time,total 12 times; Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
Biological: HPDCs-T immune therapy
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2*105-1*106 cells per time,total 12 times;
Other Names:
  • The HBsAg sensitized dendritic cells activated T cells
  • HBsAg Pulse DCs-T
Experimental: HPDCs-T immune therapy combined with LdT
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, about 2*105-1*106 cells per time,total 12 times; Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
Biological: HPDCs-T immune therapy
HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2*105-1*106 cells per time,total 12 times;
Other Names:
  • The HBsAg sensitized dendritic cells activated T cells
  • HBsAg Pulse DCs-T
No Intervention: IFN
IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks
No Intervention: ETV
Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
No Intervention: LdT
Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region

Detailed Description:

The 450 patients meeting the entry criteria are divided into 6 groups, the clinical trial procedure is divided into 3 parts, according to the following steps:

Part1 (0-12W):

  1. The research objects will be grouped according to the principle of a multicenter, randomized, open, parallel controlled clinical trial, 300 cases of cell therapy groups (100 cases with PEG-IFN treatment, LdT treatment for 100 cases, ETV treatment for 100 cases), 150 cases of control groups (PEG-IFN therapy in 50 cases, LdT therapy for 50 cases, ETV treatment for 50 cases).

    Part2 (12-36W):

  2. Cell therapy groups: enter the HBsAg sensitized dendritic cells activated T cells (HBsAg Pulse DCs-T, HPDCs-T) immune therapy combined with interferon (IFN) or nucleoside analogues treatment (NAs), infusion of HPDC-T every 2 weeks for 1 time, total 12 times.
  3. Control groups: antiviral therapy used only (IFN or NAs).

    Part3 (36-72W):

  4. The observation stage: discontinuation of interferon in the treatment of 48 weeks; NAs cases will continue on treatment with NAs.

HPDCs-T produced procedure:

The first step: 1-7 days Monocytes will be isolated from peripheral blood of patients. The monocytes obtained will be then incubated in fresh serum-free AIM-V medium (Gibco) containing 800U/ml of GM-CSF and 400U/ml of IL-4 (Peprotech) for 5 days. After 5 days of culture in vitro, The DCs induced will be cultured with a commercially available hepatitis B vaccine containing 10 ug of HBsAg (GSK) for 2 days.

The second step: 8-14 days The hepatitis B vaccine sensitized DCs (HPDCs) (from the first step) will be sub-cultured with patient's own PBMCs for 7 days: HBsAg can be efficiently presented to PBMCs by DCs, with producing HBV specific CTLs and HTLs (HPDCs-T).

The third step: 15 days The PBMCs (the second step) containing enough HPDCs-T will be transfused back into the patient.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

serum hepatitis B surface antigen(HBsAg) positive for at least 6 months; HBV DNA loads≥ 104IU/ml(Roche Cobas); Containing the IFN treatment: 2ULN ≤ ALT ≤ 10ULN and TBil ≤ 2ULN; Containing the ETV/LdT treatment: 2ULN ≤ ALT and TBil ≤ 5ULN; All patients have not received antiviral treatment or immunotherapy for the last 6 months.

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; 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: NCT01935635

Contacts
Contact: Ke Wang, Doctor +862085252372 wangke19821@126.com
Contact: Xiaojuan Wu, Bachelor +862085253372 wuxiaojuan1988@163.com

Locations
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510630
Contact: Ke Wang, Doctor    8620-85252702    wangke19821@126.com   
Contact: Yuehua Huang, Doctor    86-18922103516    huangyh53@sysu.edu.cn   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Ruijin Hospital
The second people's hospital of yunnan province
Investigators
Study Director: Yuehua Huang, Doctor Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Yuehua Huang, director of liver disease laboratory, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01935635     History of Changes
Other Study ID Numbers: 2014ZX10002002-002
Study First Received: September 1, 2013
Last Updated: September 9, 2013
Health Authority: China: Ministry of Science and Technology

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
CHB
Antiviral Agents
DCs
Biological 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

ClinicalTrials.gov processed this record on September 18, 2014