Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-01-01 @ 6:26 PM
Study NCT ID:
NCT01935635
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2013-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2013-09-01', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBV makers', 'timeFrame': '01/01/2014-31/12/2016, total 6 times (3 years)', 'description': 'HBV DNA loads,HBsAg/HBsAb titer,HBeAg/HBeAb titer'}], 'secondaryOutcomes': [{'measure': 'Coagulation tests', 'timeFrame': '01/01/2014-31/12/2016, total 6 times (3 years)', 'description': 'PT,PTA,INR'}, {'measure': 'liver function', 'timeFrame': '01/01/2014-31/12/2016, total 6 times (3 years)', 'description': 'ALT,AST,Tbil,Alb'}, {'measure': 'alpha-fetal protein', 'timeFrame': '01/01/2014-31/12/2016, total 4 times (3 years)', 'description': 'AFP;Biomarkers of hepatocellular carcinoma,one time every 24 weeks'}, {'measure': 'B ultrasound or MRI examination of the liver', 'timeFrame': '01/01/2014-31/12/2016, total 2 times (3 years)', 'description': 'The examination is performed both at the end of the pre-experiment and the main experiment'}, {'measure': 'Liver biopsy', 'timeFrame': '01/01/2014-31/12/2016, total 2 times (3 years)', 'description': 'The examination is performed both before and during experiment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CHB', 'Antiviral', 'Dentritic cells', 'Immune Therapy'], 'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '39815989', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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:\n\nPart1 (0-12W):\n\n1. 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).\n\n Part2 (12-36W):\n2. 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.\n3. Control groups: antiviral therapy used only (IFN or NAs).\n\n Part3 (36-72W):\n4. The observation stage: discontinuation of interferon in the treatment of 48 weeks; NAs cases will continue on treatment with NAs.\n\nHPDCs-T produced procedure:\n\nThe 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.\n\nThe 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).\n\nThe third step: 15 days The PBMCs (the second step) containing enough HPDCs-T will be transfused back into the patient."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nserum 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.\n\nExclusion Criteria:\n\nsuperinfection 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.'}, 'identificationModule': {'nctId': 'NCT01935635', 'briefTitle': 'A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB', 'organization': {'class': 'OTHER', 'fullName': 'Third Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'A Clinical Trial on Hepatitis B Vaccine Activated-DCs Combined With Peg-interferon or Nucleotide Analogs in Chronic Hepatitis B', 'orgStudyIdInfo': {'id': '2014ZX10002002-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HPDCs-T immune therapy combined with IFN', 'description': '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', 'interventionNames': ['Biological: HPDCs-T immune therapy']}, {'type': 'EXPERIMENTAL', 'label': 'HPDCs-T immune therapy combined with ETV', 'description': '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', 'interventionNames': ['Biological: HPDCs-T immune therapy']}, {'type': 'EXPERIMENTAL', 'label': 'HPDCs-T immune therapy combined with LdT', 'description': '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', 'interventionNames': ['Biological: HPDCs-T immune therapy']}, {'type': 'NO_INTERVENTION', 'label': 'IFN treatment', 'description': 'IFN therapy (Peg-IFN α-2b/2a):one time every 1 week according to the standards for 48 weeks'}, {'type': 'NO_INTERVENTION', 'label': 'ETV treatment', 'description': 'Entecavir(ETV)therapy:0.5mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region'}, {'type': 'NO_INTERVENTION', 'label': 'LdT treatment', 'description': 'Telbivudine(LdT)therapy:600mg per day according guidelines for the treatment of chronic hepatitis B in the Asia Pacific Region'}], 'interventions': [{'name': 'HPDCs-T immune therapy', 'type': 'BIOLOGICAL', 'otherNames': ['The HBsAg sensitized dendritic cells activated T cells', 'HBsAg Pulse DCs-T'], 'description': '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;', 'armGroupLabels': ['HPDCs-T immune therapy combined with ETV', 'HPDCs-T immune therapy combined with IFN', 'HPDCs-T immune therapy combined with LdT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510630', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "The second people's hospital of yunnan province", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '200000', 'city': 'Shanghai', 'country': 'China', 'facility': 'Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yuehua Huang, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Deparment of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': "Second People's Hospital of Yunnan Province", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'director of liver disease laboratory', 'investigatorFullName': 'Yuehua Huang', 'investigatorAffiliation': 'Third Affiliated Hospital, Sun Yat-Sen University'}}}}