Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-25 @ 11:46 PM
Study NCT ID:
NCT01732367
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2012-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus 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': 'D019259', 'term': 'Lamivudine'}, {'id': 'C053001', 'term': 'adefovir'}, {'id': 'C106812', 'term': 'adefovir dipivoxil'}, {'id': 'D000068698', 'term': 'Tenofovir'}], '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'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage number of patients with virus reactivation', 'timeFrame': 'Week 96 while on treatment', 'description': 'Percentage number of patients with virus reactivation (HBV DNA \\> 40 IU/mL on two consecutive samples taken 1 month apart, or persistent HBV DNA levels of 20-40 IU/mL on three consecutive 1 month interval) at Week 96 while on treatment.'}], 'secondaryOutcomes': [{'measure': 'Virologic response', 'timeFrame': 'Week 96 while on treatment', 'description': 'Virologic response Percentage number of patients with virus reactivation at Week 48'}, {'measure': 'Antiviral resistance', 'timeFrame': 'Week 96 while on treatment', 'description': 'Antiviral resistance percentage number of patients who developed drug resistant mutation at Week 48 and 96 while on randomized therapy.'}, {'measure': 'Biochemical response', 'timeFrame': 'Week 96 while on treatment', 'description': 'Biochemical response percentage number of patients with biochemical breakthrough at Week 48 and 96'}, {'measure': 'Serologic response', 'timeFrame': 'Week 96 while on treatment', 'description': 'Serologic response (1) HBeAg loss/seroconversion in HBeAg-positive CHB Percentage number of patients with HBeAg loss or seroconversion at Week 48 and 96.'}, {'measure': 'Safety assessment', 'timeFrame': 'Week 96 while on treatment', 'description': 'Safety assessment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tenofovir', 'Lamivudine', 'Adefovir', 'Chronic Hepatitis B'], 'conditions': ['Chronic Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '29329305', 'type': 'DERIVED', 'citation': 'Lee HJ, Kim SJ, Kweon YO, Park SY, Heo J, Woo HY, Hwang JS, Chung WJ, Lee CH, Kim BS, Suh JI, Tak WY, Jang BK. Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients. PLoS One. 2018 Jan 12;13(1):e0190581. doi: 10.1371/journal.pone.0190581. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA', 'detailedDescription': 'Recently, in Korea, long-term medication of antiviral agents and their resulting resistance expression have been the most serious cause of failure to treat chronic hepatitis B. Exp.\n\nIn particular, the annual resistance rate to lamivudine currently widely being used in Korea amounts to about 15 to 20 percents and the rate is expected to reach 70 to 80 percent in four to five years.\n\nThe guidelines by the American Association for the Study of Liver Disease (AASLD) and the European Association for the Study of the Liver (EASL) recommend a combination therapy with adefovir or tenofovir for patients with lamivudine resistant HBV .\n\nIn Korea, however, in case of combined prescription of lamivudine and adefovir, only one of them is covered by the health insurance and therefore many patients are difficult to continue treatment due to their economic conditions.\n\nTenofovir that has been developed most recently and will be placed on sale sooner or later in Korea has strong antiviral effects, causes little or no emergence of resistant viruses, and is known to have lower nephrotoxicity than adefovir.\n\nIn particular, several papers reported that tenofovir has effective and sustaining antiviral effects in patients who had other antiviral agents resistant HBV as well as those who received initial treatment. This shows that patients only with lamivudine resistant HBV can be treated only with tenofovir without a combination therapy and when they have low levels of HBV DNA, treatment is relatively effective despite their resistance to adefovir.\n\nTherefore, it is considered that tenofovir switching therapy in patients with undetectable HBV DNA after lamivudine plus adefovir combination therapy to maintain their virus response.\n\nThe results of this study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in such patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 18 or older\n* The CHB patients (both HBeAg-positive and - negative) who have at least 6 months undetectable HBV DNA (serum HBV DNA ≤ 20 IU/mL) after lamivudine plus adefovir combination therapy.\n\nExclusion Criteria:\n\n* Patients with decompensated liver disease\n* Patients with HCV, HDV or HIV\n* Patients with HCC\n* Serum ALT \\> 2x ULN level\n* Serum creatinine \\> 2.0mg/dL\n* Pregnant or lactating women\n* Women who have a plan for pregnancy within the three coming years\n* Patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection\n* Those who have no capabilities to understand and sign an informed consent'}, 'identificationModule': {'nctId': 'NCT01732367', 'briefTitle': 'TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus DNA', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Randomized Trial of Tenofovir Versus Lamivudine Plus Adefovir in Lamivudine Plus Adefovir Treated Lamivudine-resistant Chronic Hepatitis B Patients With Undetectable Hepatitis B Virus DNA.', 'orgStudyIdInfo': {'id': 'TDF0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lamivudine plus adefovir', 'description': 'Continue lamivudine/adefovir add on treatment (standard treatment)', 'interventionNames': ['Drug: Lamivudine plus adefovir']}, {'type': 'EXPERIMENTAL', 'label': 'Tenofovir', 'description': 'Switch from lamivudine/adefovir add on treatment to tenofovir monotherapy', 'interventionNames': ['Drug: Tenofovir']}], 'interventions': [{'name': 'Lamivudine plus adefovir', 'type': 'DRUG', 'otherNames': ['Zeffix', 'Hepsera'], 'description': 'Lamivudine 100mg QD for 96 weeks + Adefovir 10mg QD for 96 weeks', 'armGroupLabels': ['Lamivudine plus adefovir']}, {'name': 'Tenofovir', 'type': 'DRUG', 'otherNames': ['Viread'], 'description': 'Tenofovir 300mg QD for 96 weeks', 'armGroupLabels': ['Tenofovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ASI|KR|KS002|TAEGU', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Department of Internal Medicine, Keimyung University Dongsan Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Byoung Kuk Jang, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Keimyung University Dongsan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Daegu Catholic University Medical Center', 'class': 'OTHER'}, {'name': 'DongGuk University', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, {'name': 'Yeungnam University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Keimyung University Dongsan Medical Center', 'investigatorFullName': 'Jang Byoung Kuk', 'investigatorAffiliation': 'Keimyung University Dongsan Medical Center'}}}}