Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT03356834
Status:
COMPLETED
Last Update Posted:
2025-03-26
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF
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': 'C442442', 'term': 'tenofovir alafenamide'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'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'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 575}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-11-24', 'lastUpdatePostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Antiviral response of TAF', 'timeFrame': '60 months', 'description': 'Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients'}], 'secondaryOutcomes': [{'measure': 'Improvement of renal function and bone mineral density in CHB patients switching to TAF', 'timeFrame': '60 months', 'description': 'Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic hepatitis B', 'Efficacy, safety, and tolerability', 'Tenofovir alafenamide'], 'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.', 'detailedDescription': 'Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Chronic hepatitis B,\n2. Antiviral experienced,\n3. Currently on long term TDF anti-HBV treatment,\n4. HBV DNA \\< 6 log IU/ml (LLOD)\n5. Able to sign the consent form of anticipating in the study\n\nExclusion Criteria:\n\n1. Co-infected with HCV, HIV or other viral hepatitis,\n2. Diagnosis of HCC'}, 'identificationModule': {'nctId': 'NCT03356834', 'acronym': 'SWITAF', 'briefTitle': 'Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF', 'organization': {'class': 'OTHER', 'fullName': 'Humanity and Health Research Centre'}, 'officialTitle': 'Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF', 'orgStudyIdInfo': {'id': 'HumanityHGLC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TDF switch to TAF', 'description': 'Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily', 'interventionNames': ['Drug: Tenofovir alafenamide(TAF)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Maintaining on TDF', 'description': 'Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily', 'interventionNames': ['Drug: Tenofovir disoproxil fumarate(TDF)']}], 'interventions': [{'name': 'Tenofovir alafenamide(TAF)', 'type': 'DRUG', 'otherNames': ['VEMLIDY®'], 'description': '25 mg tablet administered orally once daily', 'armGroupLabels': ['TDF switch to TAF']}, {'name': 'Tenofovir disoproxil fumarate(TDF)', 'type': 'DRUG', 'otherNames': ['VIREAD®'], 'description': '300 mg tablet administered orally once daily', 'armGroupLabels': ['Maintaining on TDF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00852', 'city': 'Hong Kong', 'state': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Humanity and Health GI and Liver Centre', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Humanity and Health Research Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Humanity & Healthy Medical Group President', 'investigatorFullName': 'George Lau', 'investigatorAffiliation': 'Humanity and Health Research Centre'}}}}