Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT00513968
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2007-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053001', 'term': 'adefovir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-03', 'studyFirstSubmitDate': '2007-08-08', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events and clinical laboratory abnormalities', 'timeFrame': '48 weeks'}], 'secondaryOutcomes': [{'measure': 'HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity', 'timeFrame': '24, 28, 32, 42, 44, and 48 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening\n* Chronic hepatitis B infected patient with positive HBeAg at screening\n* Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry\n* HBV DNA more than 1x10\\^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening\n* Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir\n* Patient with ALT value between ULN x 1.5 and ULN x 5 at screening\n* Patient given a written consent voluntarily\n\nExclusion Criteria:\n\n* Have uncompensated liver disease\n* Serum creatinine \\> ULN x 1.5\n* Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)\n* Had a previous liver or bone marrow transplant\n* Are currently taking any immunosuppressant or any possible immune modulatory drugs\n* Women who are pregnant or breastfeeding\n* Woman or man who plans a birth for study duration\n* Any experience of severe adverse drug reaction or any medical history of severe allergic disease\n* Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease\n* Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae)\n* Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein\n* Patient with any present malignant tumor except liver or its history\n* Other inappropriate patient in discretion of investigator"}, 'identificationModule': {'nctId': 'NCT00513968', 'briefTitle': 'Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genexine, Inc.'}, 'officialTitle': 'A Single Center, Randomized, Open-label, Dose Escalating Phase I Study to Evaluate the Safety of Intramuscularly Administered DNA Vaccine (HB-110) Combined With Oral Antiviral (Adefovir) in Subjects With Chronic Hepatitis B Over a 48-week Period', 'orgStudyIdInfo': {'id': 'HB110_HB_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'HB-110 2mg, 4mg or 8mg combined with Adefovir', 'interventionNames': ['Genetic: a mixed plasmid DNA (HB-110)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'II', 'description': 'Adefovir', 'interventionNames': ['Drug: Adefovir']}], 'interventions': [{'name': 'a mixed plasmid DNA (HB-110)', 'type': 'GENETIC', 'description': 'HB-110 2mg (or 4mg or 8mg), im, every other week, from week 0 to week 22 (total 12 injections) and Adefovir(Adefovir dipivoxil 10mg), od, from week -10 to from week 48.', 'armGroupLabels': ['I']}, {'name': 'Adefovir', 'type': 'DRUG', 'description': 'Adefovir(Adefovir dipivoxil)10mg, od, from week -10 to week 48.', 'armGroupLabels': ['II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Kangnam St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Prof. Seung-kyu Yoon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Department of Gastroenterology at Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genexine, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}