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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Second People's Hospital of Yunnan Province | OTHER |
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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
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):
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):
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.
Control groups: antiviral therapy used only (IFN or NAs).
Part3 (36-72W):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HPDCs-T immune therapy combined with IFN | Experimental | 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 combined with ETV | Experimental | 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 combined with LdT | Experimental | 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 |
|
| IFN treatment | No Intervention | IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks | |
| ETV treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HPDCs-T immune therapy | Biological | 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; |
| Measure | Description | Time Frame |
|---|---|---|
| HBV makers | HBV DNA loads,HBsAg/HBsAb titer,HBeAg/HBeAb titer | 01/01/2014-31/12/2016, total 6 times (3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Coagulation tests | PT,PTA,INR | 01/01/2014-31/12/2016, total 6 times (3 years) |
| liver function | ALT,AST,Tbil,Alb | 01/01/2014-31/12/2016, total 6 times (3 years) |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Yuehua Huang, Doctor | Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China | ||
| The second people's hospital of yunnan province |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39815989 | Derived | 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. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region
| LdT treatment | No Intervention | Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region |
|
| alpha-fetal protein | AFP;Biomarkers of hepatocellular carcinoma,one time every 24 weeks | 01/01/2014-31/12/2016, total 4 times (3 years) |
| B ultrasound or MRI examination of the liver | The examination is performed both at the end of the pre-experiment and the main experiment | 01/01/2014-31/12/2016, total 2 times (3 years) |
| Liver biopsy | The examination is performed both before and during experiment. | 01/01/2014-31/12/2016, total 2 times (3 years) |
| Kunming |
| Yunnan |
| 650000 |
| China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | 200000 | China |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |