Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-02-24 @ 11:00 AM
Study NCT ID:
NCT00558493
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2007-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Switching Study From Lamivudine to Clevudine in the 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': 'C034935', 'term': 'clevudine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-24', 'studyFirstSubmitDate': '2007-11-14', 'studyFirstSubmitQcDate': '2007-11-14', 'lastUpdatePostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-15', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HBV DNA \\> 2,000 copies/mL at screening\n* Patients who have compensated liver disease (Child-Pugh score =\\<6)\n* Patients without LMV resistant mutation by RFMP assay\n* Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy\n* Patients who can submit the written consent and comply with the claims postulated of this clinical trial\n\nExclusion Criteria:\n\n* Currently receiving antiviral except LMV or corticosteroid therapy\n* Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months\n* Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening\n* Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period\n* Patients who is co-infected with HCV, HDV or HIV\n* Serious concurrent medical conditions\n* Prior organ transplantation\n* Patient has creatinine clearance less than 60mL/min as estimated by the following formula:\n\n\\[(140-age in years) (body weight \\[kg\\])\\] / \\[(72) (serum creatinine\\] \\[mg/dL\\])\\[Note: multiply estimates by 0.85 for women\\]'}, 'identificationModule': {'nctId': 'NCT00558493', 'briefTitle': 'Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bukwang Pharmaceutical'}, 'officialTitle': 'Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment', 'orgStudyIdInfo': {'id': 'KB-406'}, 'secondaryIdInfos': [{'id': 'KB-406'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'switching treatment from lamivudine to clevudine', 'interventionNames': ['Drug: Clevudine']}], 'interventions': [{'name': 'Clevudine', 'type': 'DRUG', 'description': 'clevudine 30 mg qd for 24 seeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Youngnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bukwang Pharmaceutical', 'class': 'INDUSTRY'}}}}