A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB
NCT ID: NCT01935635
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
400 participants
INTERVENTIONAL
2015-01-31
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HPDCs-T immune therapy 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
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;
HPDCs-T immune therapy 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
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;
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
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;
IFN treatment
IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks
No interventions assigned to this group
ETV treatment
Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
No interventions assigned to this group
LdT treatment
Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Second People's Hospital of Yunnan Province
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Yuehua Huang
director of liver disease laboratory
Principal Investigators
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Yuehua Huang, Doctor
Role: STUDY_DIRECTOR
Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University
Locations
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The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The second people's hospital of yunnan province
Kunming, Yunnan, China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Countries
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References
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Gu Y, Gu L, Chen L, Li J, Liao C, Bi Y, Huang Z, Cai W, Wei J, Huang Y. Immunotherapy Using HBV Vaccine Pulsed DCs and Induced T-Cells Combined Antiviral Drugs in Treatment Naive CHB Patients-A Multi-Centre Phase II Study. J Viral Hepat. 2025 Feb;32(2):e14045. doi: 10.1111/jvh.14045.
Other Identifiers
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2014ZX10002002-002
Identifier Type: -
Identifier Source: org_study_id