Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-01-01 @ 2:18 AM
Study NCT ID:
NCT00362505
Status:
TERMINATED
Last Update Posted:
2017-02-01
First Post:
2006-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'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': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C034935', 'term': 'clevudine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-06', 'completionDateStruct': {'date': '2006-03'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2006-08-08', 'studyFirstSubmitQcDate': '2006-08-08', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.'}], 'secondaryOutcomes': [{'measure': 'Efficacy:; Proportion of patients with HBV DNA below the assay Limit of Detection; Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain); Proportion of ALT normalization'}]}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is between 18 and 60, inclusive\n2. Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.\n3. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.\n4. Patient has bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL at week 48 in L-FMAU-301 or L-FMAU-302.\n5. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.\n6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Patients with HBV DNA \\< 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301\n2. Patients with HBV DNA \\< 4,700 copies/mL and ALT normalization in L-FMAU-302\n3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.\n4. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.\n5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.\n6. Patient is coinfected with HCV, HDV or HIV.\n7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein \\> 50 ng/mL\n8. Patient is pregnant or breast-feeding.\n9. 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. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)\n10. Patient has a clinically relevant history of abuse of alcohol or drugs.\n11. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.\n12. 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\\]\n\n13.Patient whom investigator consider is not suitable in this study'}, 'identificationModule': {'nctId': 'NCT00362505', 'briefTitle': 'Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bukwang Pharmaceutical'}, 'officialTitle': 'An Open-label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials', 'orgStudyIdInfo': {'id': 'L-FMAU-303'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clevudine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ami-dong, Seo-gu', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital'}, {'city': 'Amnam-dong, Seo-gu', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Kosin Medical Center', 'geoPoint': {'lat': 35.06667, 'lon': 129.01667}}, {'city': 'Gaegeum-dong', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Pusan Paik Hospital'}, {'city': 'Daesa-dong, Jung-gu', 'state': 'Daechon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital'}, {'city': 'Daemyoung-dong, Nam-gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center'}, {'city': 'Jung-gu,', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyumg University Dongsan Medical Center'}, {'city': 'Jung-gu', 'state': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Medical Hospital'}, {'city': 'Seoul', 'state': 'Guro-gu', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Hak-1-dong, Dong-gu', 'state': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital'}, {'city': 'Bupyoung-dong, Bupyoung-gu', 'state': 'Incheon', 'country': 'South Korea', 'facility': "St. Mercy's Hospital"}, {'city': 'Sinhung-dong, Jung-gu', 'state': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital'}, {'city': 'Iksan', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Wonkwang University Hospital', 'geoPoint': {'lat': 35.94389, 'lon': 126.95444}}, {'city': 'Jeonju', 'state': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Seoul', 'state': 'Jongno-Gu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ilsan-gu', 'state': 'Kyounggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.66194, 'lon': 126.77611}}, {'city': 'Puch’un', 'state': 'Kyounggi-do', 'country': 'South Korea', 'facility': "St. Holly Family Mary's Hospital", 'geoPoint': {'lat': 34.49028, 'lon': 126.70583}}, {'city': 'Seongnam-gu', 'state': 'Kyounggi-do', 'country': 'South Korea', 'facility': 'Pochon CHA University Hospital'}, {'city': 'Incheon', 'state': 'Namdong-Gu', 'country': 'South Korea', 'facility': 'Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Anam-dong, Sungbuk-ku', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.58685, 'lon': 127.02755}}, {'city': 'Banpo-dong, Seocho-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': "KangNam St. Mary's Hospital", 'geoPoint': {'lat': 37.49528, 'lon': 126.99361}}, {'city': 'Daelim-dong, Yongdeungpo-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Kangnam Sacred Heart Hospital'}, {'city': 'Dogok-dong, Kangnam-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Yongdong Severance Hospital', 'geoPoint': {'lat': 37.48928, 'lon': 127.04548}}, {'city': 'Gongneung-dong, Nowon-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Korea Cancer Center Hospital', 'geoPoint': {'lat': 37.63614, 'lon': 127.08899}}, {'city': 'Hannam-dong, Yongsan-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital', 'geoPoint': {'lat': 37.5365, 'lon': 127.0027}}, {'city': 'Ilwon-dong, Songpa-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center'}, {'city': 'Jeo-dong', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Paik Hospital'}, {'city': 'Mok-dong, Yangcheon-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Ehwa Womans University Mokdong Hospital'}, {'city': 'Pungnap-dong, Kangnam-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Asan Medical Center'}, {'city': 'Pyoung-dong, Chongro-gu,', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital'}, {'city': 'Shinchon- Dong, Seodaemun-gu', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital'}, {'city': 'Ji-dong,, Paldal-gu', 'state': 'Suwon', 'country': 'South Korea', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 37.2825, 'lon': 127.025}}, {'city': 'Seoul', 'state': 'Yungdungpo-Gu', 'country': 'South Korea', 'facility': "St. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyo-Suk Lee, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bukwang Pharmaceutical', 'class': 'INDUSTRY'}}}}