Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-12 @ 9:36 PM
Study NCT ID:
NCT05398393
Status:
UNKNOWN
Last Update Posted:
2022-06-01
First Post:
2022-03-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}], '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'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-15', 'size': 204838, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-05-25T12:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2022-03-10', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change from baseline liver stiffness measurement at 6/12month', 'timeFrame': 'baseline, follow up of 6,12month', 'description': 'test liver stiffness measurement and controlled attenuation parament through transient elastography(FibroTouch)'}, {'measure': 'ultrasonography', 'timeFrame': 'baseline, follow up of 6,12month', 'description': 'liver ultrasonography'}], 'primaryOutcomes': [{'measure': 'change from baseline HBV-DNA at 1/3/6/12month', 'timeFrame': 'baseline, follow up of 1,3,6,12month', 'description': 'test virological response rate'}, {'measure': 'change from baseline level of blood lipid at 1/3/6/12month', 'timeFrame': 'baseline, follow up of 1,3,6,12month', 'description': 'test blood lipid level'}], 'secondaryOutcomes': [{'measure': 'change from baseline serum calcium at 6/12month', 'timeFrame': 'baseline, follow up of 6,12month', 'description': 'test blood serum calcium'}, {'measure': 'change from baseline serum phosphorus at 6/12month', 'timeFrame': 'baseline, follow up of 6,12month', 'description': 'test blood serum phosphorus'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tenofovir Amibufenamide'], 'conditions': ['Hepatitis B, Chronic', 'Lipid Disorder']}, 'referencesModule': {'references': [{'pmid': '33211179', 'type': 'RESULT', 'citation': 'Suzuki K, Suda G, Yamamoto Y, Furuya K, Baba M, Nakamura A, Miyoshi H, Kimura M, Maehara O, Yamada R, Kitagataya T, Yamamoto K, Shigesawa T, Nakamura A, Ohara M, Kawagishi N, Nakai M, Sho T, Natsuizaka M, Morikawa K, Ogawa K, Ohnishi S, Sakamoto N; NORTE Study Group. Tenofovir-disoproxil-fumarate modulates lipid metabolism via hepatic CD36/PPAR-alpha activation in hepatitis B virus infection. J Gastroenterol. 2021 Feb;56(2):168-180. doi: 10.1007/s00535-020-01750-3. Epub 2020 Nov 19.'}, {'pmid': '32310899', 'type': 'RESULT', 'citation': 'Lacey A, Savinelli S, Barco EA, Macken A, Cotter AG, Sheehan G, Lambert JS, Muldoon E, Feeney E, Mallon PW, Tinago W; UCD ID Cohort Study. Investigating the effect of antiretroviral switch to tenofovir alafenamide on lipid profiles in people living with HIV. AIDS. 2020 Jul 1;34(8):1161-1170. doi: 10.1097/QAD.0000000000002541.'}, {'pmid': '34044856', 'type': 'RESULT', 'citation': 'Ikeda M, Wakabayashi Y, Okamoto K, Yanagimoto S, Okugawa S, Moriya K. Changing trends in lipid profile and biomarkers of renal function and bone metabolism before and after switching from tenofovir disoproxil fumarate to tenofovir alafenamide: a prospective observational study. AIDS Res Ther. 2021 May 27;18(1):30. doi: 10.1186/s12981-021-00354-y.'}, {'pmid': '32980447', 'type': 'RESULT', 'citation': 'Li M, Zhou L, Dorsey HG, Musoff C, Jnr DA, Schoen N, Djan K, Paintsil E. Tenofovir alafenamide does not inhibit mitochondrial function and cholesterol biosynthesis in human T lymphoblastoid cell line. Antiviral Res. 2020 Nov;183:104948. doi: 10.1016/j.antiviral.2020.104948. Epub 2020 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is a new second generation of tenofovir(TFV) and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.', 'detailedDescription': 'In June 2021, Chinese Food and Drug Administration approved the launch of the self-developed new drug Tenofovir Amibufenamide(TMF). TMF is the phosphoramidite precursor of Tenofovir, belonging to the nucleoside reverse transcriptase and owning higher cell membrane penetration rate, which make it easier to enter hepatocytes and achieve liver-targeted therapy. Meanwhile, TMF can effectively improve drug stability in plasma and reduce systemic tenofovir(TFV) exposure, and make long-term treatment safer.\n\nPrevious studies have shown that tenofovir disoproxil (TDF), the first generation of TFV, had the effect of lowering blood lipids. While patients who switched to tenofovir alafenamide (TAF), the second generation of TFV, had elevated blood lipids. TMF is a new second generation of TFV and its effect on blood lipids is unclear. Our study aims to figure out the effect of TMF on serum lipid level in the process of antiviral therapy for chronic hepatitis B patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-70 years old;\n2. Chronic hepatitis B patients who meet the CHB diagnostic criteria of "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (Chinese 2019 version)";\n3. HBV-DNA can be detected (≥20IU/mL);\n4. With or without liver cirrhosis caused by hepatitis B;\n5. The treatment plan is TMF antiviral therapy, and no other antiviral drugs are used for at least 1 year before;\n6. The clinical data are relatively complete, and the follow-up time reaches 24 weeks (6 months).\n\nExclusion Criteria:\n\n1. Patients with primary liver cancer or liver metastases;\n2. Combined with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus infection;\n3. Combined with alcoholic liver disease, drug-induced liver disease, autoimmune liver disease and liver disease caused by other factors;\n4. History of treatment of dysglycemia and dyslipidemia;\n5. Patients with lactose intolerance;\n6. Pregnant women and lactating women;\n7. Patients with other serious systemic diseases.'}, 'identificationModule': {'nctId': 'NCT05398393', 'briefTitle': 'An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'An Experimental Study on the Effect of Tenofovir Amibufenamide on Blood Lipid During Anti-HBV Treatment', 'orgStudyIdInfo': {'id': 'UHCT21612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'group A', 'description': 'normal blood lipid level at baseline', 'interventionNames': ['Drug: oral Tenofovir Amibufenamide 25mg each day']}, {'type': 'OTHER', 'label': 'group B1', 'description': 'baseline blood lipid is elevated and treat with lipid-lowering drugs', 'interventionNames': ['Drug: oral Tenofovir Amibufenamide 25mg each day', 'Drug: lipid lowering drugs (e.g. Atorvastatin and amlodipine.)']}, {'type': 'OTHER', 'label': 'group B2', 'description': 'baseline blood lipid is elevated and without lipid-lowering drugs treatment', 'interventionNames': ['Drug: oral Tenofovir Amibufenamide 25mg each day']}], 'interventions': [{'name': 'oral Tenofovir Amibufenamide 25mg each day', 'type': 'DRUG', 'description': 'patients in three groups respectively take one tablet of Tenofovir Amibufenamide(25mg) every day', 'armGroupLabels': ['group A', 'group B1', 'group B2']}, {'name': 'lipid lowering drugs (e.g. Atorvastatin and amlodipine.)', 'type': 'DRUG', 'description': 'lipid lowering drugs, , patients in group B1 continue take lipid lowering drugs', 'armGroupLabels': ['group B1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Union hosipital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Wuhan Union hosipital', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated to Tongji Medical College, Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'url': 'http://www.whuh.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'the data will be available after June 2023', 'ipdSharing': 'YES', 'description': 'IPD will be shared including study protocol, statistical analysis, informed consent plan, clinical study report and analytic code', 'accessCriteria': 'academic exchange'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor, chief doctor', 'investigatorFullName': 'Jin Ye', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}