Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-26 @ 12:39 AM
Study NCT ID:
NCT00798460
Status:
TERMINATED
Last Update Posted:
2011-06-23
First Post:
2008-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
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'}, {'id': 'C106812', 'term': 'adefovir dipivoxil'}, {'id': 'C034935', 'term': 'clevudine'}, {'id': 'D019259', 'term': 'Lamivudine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'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'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'could not enroll patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-22', 'studyFirstSubmitDate': '2008-11-25', 'studyFirstSubmitQcDate': '2008-11-25', 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HBV DNA titer < 300 copies/mL', 'timeFrame': '48 week'}], 'secondaryOutcomes': [{'measure': 'Normalization of serum ALT, loss of HBeAg and HBsAg, incidence of adefovir resistance', 'timeFrame': '48 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic hepatitis B', 'lamivudine resistance', 'clevudine'], 'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the optimal antiviral treatment for lamivudine resistant hepatitis B patients.', 'detailedDescription': 'Lamivudine with adefovir combination therapy has been known as effective antiviral therapy for lamivudine resistant chronic hepatitis B patients. It is superior to adefovir monotherapy since the incidence of viral breakthrough of combination therapy used to be less than that of adefovir monotherapy in lamivudine resistant chronic hepatitis B patients. Clevudine, which is being marketed in Korea, is a nucleoside analogue of the unnatural beta-L configuration that has potent activity against HBV. It has demonstrated potent antiviral efficacy and significant biochemical improvement after 24 weeks of therapy. We hypothesized that clevudine plus adefovir combination therapy for lamivudine resistant patients might be as effective as the lamivudine plus adefovir combination therapy.\n\nIn detail, we designed to perform this clinical study comparing the combination of clevudine and adefovir with lamivudine plus adefovir in lamivudine resistant chronic hepatitis B patient. Total treatment duration of both groups will be 12 months, and compare the efficacy of antiviral effects of these drugs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HBsAg positive and anti-HBs negative more than 6 months\n* YMDD mutation (+)during lamivudine therapy\n* Serum ALT more than two times upper normal value\n\nExclusion Criteria:\n\n* HAV IgM Ab + and/or HCV Ab+ and/or HDV Ab and/or HIV Av+\n* The sign of decompensated liver disease\n* Pregnant or lactating woman\n* The history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease\n* Hemoglobin less than 8 g/dL (male), 7.5g/dL (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3\n* Serum creatinine more than 1.5 times upper normal limit value\n* The sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%'}, 'identificationModule': {'nctId': 'NCT00798460', 'briefTitle': 'Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'A Multicenter, Randomized, Controlled Tial of Combination Therapy for Lamivudine-resistant Chronic Hepatitis B Patient: Comparing Clevudine Plus Adefovir With Lamivudine Plus Adefovir', 'orgStudyIdInfo': {'id': 'IB-0809-055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lamivudine plus adefovir', 'interventionNames': ['Drug: adefovir', 'Drug: lamivudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clevudine plus adefovir', 'interventionNames': ['Drug: adefovir', 'Drug: clevudine']}], 'interventions': [{'name': 'adefovir', 'type': 'DRUG', 'otherNames': ['Hepsera'], 'description': 'adefovir 10mg', 'armGroupLabels': ['Clevudine plus adefovir', 'Lamivudine plus adefovir']}, {'name': 'clevudine', 'type': 'DRUG', 'otherNames': ['Levovir'], 'description': 'clevudine 30mg', 'armGroupLabels': ['Clevudine plus adefovir']}, {'name': 'lamivudine', 'type': 'DRUG', 'otherNames': ['Zeffix'], 'description': 'lamivudine 100mg', 'armGroupLabels': ['Lamivudine plus adefovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '411-706', 'city': 'Goyang', 'state': 'Gyunggi', 'country': 'South Korea', 'facility': 'Ilsanpaik hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}], 'overallOfficials': [{'name': 'June Sung Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Ilsanpaik hospital, Inje Univeristy, 2240 Daewha-dong, Ilsanseo-gu, Goyang, Gyunggi, Korea, 411-706'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bukwang Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'June Sung Lee', 'oldOrganization': 'Ilsanpaik hospital, Inje University'}}}}