Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
Study NCT ID:
NCT01480492
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2011-11-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077712', 'term': 'Telbivudine'}], 'ancestors': [{'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-28', 'studyFirstSubmitDate': '2011-11-15', 'studyFirstSubmitQcDate': '2011-11-28', 'lastUpdatePostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy', 'timeFrame': 'base line-4 weeks-12 weeks-24 weeks-end of therapy'}], 'secondaryOutcomes': [{'measure': 'Decline of hepatitis B e antigen (HBeAg) level', 'timeFrame': 'base line-4weeks-12weeks-24weeks-end of therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HBV', 'Immune', 'antiviral therapy'], 'conditions': ['HBeAg Positive Chronic Hepatitis B Infection']}, 'referencesModule': {'references': [{'pmid': '25071343', 'type': 'DERIVED', 'citation': 'Li CZ, Hu JJ, Xue JY, Yin W, Liu YY, Fan WH, Xu H, Liang XS. Viral infection parameters not nucleoside analogue itself correlates with host immunity in nucleoside analogue therapy for chronic hepatitis B. World J Gastroenterol. 2014 Jul 28;20(28):9486-96. doi: 10.3748/wjg.v20.i28.9486.'}]}, 'descriptionModule': {'briefSummary': 'During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '66 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'inclusion criteria:\n\n* 18-65 years old\n* chronic HBV infection\n* HBeAg positive,HBV DNA more than 10E5 IU/mL\n* ALT ≥2×UTL\n\nexclusion criteria:\n\n* with liver cancer\n* with liver failure\n* pregnant'}, 'identificationModule': {'nctId': 'NCT01480492', 'briefTitle': 'Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Study the Effect of Nucleoside on Host Immune in Patients With CHB', 'orgStudyIdInfo': {'id': 'HBV20111115'}, 'secondaryIdInfos': [{'id': '09zr400500', 'type': 'OTHER_GRANT', 'domain': 'Shanghai Natural Science Fund'}, {'id': '30972600', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science Foundation of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'therapy', 'interventionNames': ['Drug: Telbivudine']}], 'interventions': [{'name': 'Telbivudine', 'type': 'DRUG', 'description': '600mg,1/d,one year', 'armGroupLabels': ['therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wan Mo Bin, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cz Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Cz Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}