Ignite Creation Date:
2024-05-06 @ 1:57 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01935635
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2013-09-01
Brief Title:
A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB
Sponsor:
Third Affiliated Hospital Sun Yat-Sen University
Organization:
Third Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
A Clinical Trial on Hepatitis B Vaccine Activated-DCs Combined With Peg-interferon or Nucleotide Analogs in Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 800Uml of GM-CSF and 400Uml 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 patients 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
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 800Uml of GM-CSF and 400Uml 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None