Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-27 @ 5:38 AM
Study NCT ID:
NCT00558818
Status:
COMPLETED
Last Update Posted:
2012-07-26
First Post:
2007-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Study With Clevudine
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, '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'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR', 'timeFrame': 'Screening, day1,every 12 weeks during treatment period(96weeks)'}], 'secondaryOutcomes': [{'measure': 'Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation', 'timeFrame': 'Screening, day1, every 12 weeks during treatment period(96 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patient with DNA levels \\>=1 x 10\\^5 copies/mL within 30 days of baseline.\n* Patient is documented to be HBsAg positive for \\> 6 months.\n* Patient has ALT levels \\>=80 IU/L\n* Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.\n\nExclusion Criteria.\n\n* Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.\n* Patients previously treated with interferon within the previous 6 months.\n* Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.\n* Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.\n* Patient is coinfected with HCV, HDV or HIV.\n* Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma\n* Patient is pregnant or breast-feeding.\n* Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.\n* Patient has a clinically relevant history of abuse of alcohol or drugs.\n* Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator\'s opinion might interfere with therapy.\n* Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \\[kg\\])/(72) (serum creatinine \\[mg/dL\\]) \\[Note: multiply estimates by 0.85 for women\\]'}, 'identificationModule': {'nctId': 'NCT00558818', 'briefTitle': 'Long-term Study With Clevudine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bukwang Pharmaceutical'}, 'officialTitle': 'A Phase lV Study to Evaluate the Long-term Safety and Efficacy of Clevudine in the Patients Chronically Infected With Hepatitis B Virus', 'orgStudyIdInfo': {'id': 'KOR-404'}, 'secondaryIdInfos': [{'id': 'KOR-404'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Clevudine', 'type': 'DRUG', 'description': 'clevudine 30 mg qd'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'KoreaUniversity Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bukwang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'hunjun jang', 'oldOrganization': 'Bukwang Pharmaceutical'}}}}