Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-08 @ 5:55 AM
Study NCT ID:
NCT00625560
Status:
COMPLETED
Last Update Posted:
2012-05-08
First Post:
2008-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
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': 'C413685', 'term': 'entecavir'}, {'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': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-07', 'studyFirstSubmitDate': '2008-02-11', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy', 'timeFrame': 'at Week 96'}], 'secondaryOutcomes': [{'measure': 'Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy', 'timeFrame': 'at Week 48'}, {'measure': 'Percentage number of patients who developed drug resistant mutations while on randomized therapy', 'timeFrame': 'at Week 48 and Week 96'}, {'measure': 'Change from baseline in mean HBV DNA', 'timeFrame': 'at Week 48 and 96'}, {'measure': 'Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion', 'timeFrame': 'at Week 48 and 96'}, {'measure': 'Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment', 'timeFrame': 'Follow up period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic hepatitis B', 'Lamivudine', 'Entecavir'], 'conditions': ['Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.', 'detailedDescription': 'Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.\n\nExclusion Criteria:\n\n* All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.\n* Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.\n* Subjects should have ALT \\< 10 x ULN, and no evidence of hepatocellular carcinoma.\n* Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.\n* Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.'}, 'identificationModule': {'nctId': 'NCT00625560', 'briefTitle': 'Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA', 'orgStudyIdInfo': {'id': '4-2007-0351'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'entecavir 1.0 mg QD', 'interventionNames': ['Drug: Entecavir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'lamivudine 100 mg QD', 'interventionNames': ['Drug: Lamivudine']}], 'interventions': [{'name': 'Entecavir', 'type': 'DRUG', 'otherNames': ['Baraclude 1.0mg'], 'description': 'entecavir 1.0 mg QD', 'armGroupLabels': ['A']}, {'name': 'Lamivudine', 'type': 'DRUG', 'otherNames': ['Zeffix 100mg'], 'description': 'lamivudine 100 mg QD', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '602-739', 'city': 'Busan', 'state': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University School of Medicine', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sang Hoon Ahn, M.D.Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Yonsei Univsersity College of Medicine'}, {'name': 'Do Young Kim, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Yonsei University'}, {'name': 'Jun Yong Park, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University'}, {'name': 'Jeong Heo, M.D.Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pusan National University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pusan National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sang Hoon Ahn', 'investigatorAffiliation': 'Yonsei University'}}}}