Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-03-06 @ 11:50 AM
Study NCT ID:
NCT01264133
Status:
TERMINATED
Last Update Posted:
2014-12-18
First Post:
2010-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
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'}, {'id': 'C053001', 'term': 'adefovir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2010-12-19', 'studyFirstSubmitQcDate': '2010-12-20', 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with HBV DNA levels < 60 IU/mL', 'timeFrame': '48 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with chronic hepatitis B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient is 18 years and older.\n2. Patient is documented to be HBsAg positive for \\> 6 months.\n3. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.\n4. Patient has ALT levels \\>=80 IU/L\n5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis \\<= 6)\n6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.\n\nExclusion Criteria:\n\n1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.\n2. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.\n3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.\n4. Patient is coinfected with HCV, HDV or HIV.\n5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.\n6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma\n7. Patient with previous liver transplantation\n8. Patient is pregnant or breast-feeding.\n9. Patient has a clinically relevant history of abuse of alcohol or drugs.\n10. 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.\n11. 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': 'NCT01264133', 'briefTitle': 'A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bukwang Pharmaceutical'}, 'officialTitle': 'An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B', 'orgStudyIdInfo': {'id': 'CLV-411'}, 'secondaryIdInfos': [{'id': 'CLV-411'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Clevudine, Adefovir', 'type': 'DRUG', 'description': 'Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg qd'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bukwang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Byungchul Yoo', 'oldOrganization': 'Samsung Medical Center'}}}}