Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-18 @ 12:15 AM
Study NCT ID:
NCT03752658
Status:
UNKNOWN
Last Update Posted:
2019-11-26
First Post:
2018-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAF Real World Study for Universal Effectiveness
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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, urine and whole blood will be restored in central lab'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-11-21', 'lastUpdatePostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of participants with HBV DNA < 20 IU/mL', 'timeFrame': '36 months', 'description': 'proportion of participants with HBV DNA \\< 20 IU/mL as measured by the COBAS TaqMan HBV Test (Roche Molecular Diagnostics, Pleasanton, CA, USA), with taken at 36 months'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients with HBV DNA < 20 IU/mL', 'timeFrame': '12 months', 'description': 'The proportion of patients with HBV DNA \\< 20 IU/mL at 12 months'}, {'measure': 'The proportion of patients with HBV DNA <300 copies/mL', 'timeFrame': '12 months', 'description': 'The proportion of patients with HBV DNA \\<300 copies/mL at 12 months'}, {'measure': 'The proportion of patients with HBV DNA < 20 IU/mL', 'timeFrame': '24 months', 'description': 'The proportion of patients with HBV DNA \\< 20 IU/mL at 24 months'}, {'measure': 'The proportion of patients with HBV DNA <300 copies/mL IU/mL', 'timeFrame': '24 months', 'description': 'The proportion of patients with HBV DNA \\<300 copies/mL at 24 months'}, {'measure': 'The proportion of patients with HBV DNA <300 copies/mL IU/mL', 'timeFrame': '36 months', 'description': 'The proportion of patients with HBV DNA \\<300 copies/mL at 36 months'}, {'measure': 'Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss', 'timeFrame': '36 months', 'description': 'Proportion of participants with Hepatitis B e Antigen (HBeAg) Loss at 36 months'}, {'measure': 'Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe)', 'timeFrame': '36 months', 'description': 'Proportion of participants with seroconversion to Anti-Hepatitis B e-Antigen (Anti-HBe) at 36 months'}, {'measure': 'Proportion of participants with Normal Alanine Aminotransferase (ALT)', 'timeFrame': '36 months', 'description': 'Proportion of participants with Normal Alanine Aminotransferase (ALT) at 36 months'}, {'measure': 'Change from baseline in fibrosis as assessed by Fibroscan®', 'timeFrame': '36 months', 'description': 'Change from baseline in fibrosis as assessed by Fibroscan® at 36 months'}, {'measure': 'Percent Change from baseline in Bone Mineral Density (BMD)', 'timeFrame': '36 months', 'description': 'Percent Change from baseline in Bone Mineral Density (BMD) at 36 months'}, {'measure': 'Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG)', 'timeFrame': '36 months', 'description': 'Change from baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFR-CG) at 36 months'}, {'measure': 'the rate of mother-to-child transmission of HBV', 'timeFrame': 'at postpartum 6 months', 'description': 'For unplanned pregnant subjects, if not withdrawn, mother-to-child transmission (MTCT) rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis b']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated.', 'detailedDescription': "This study is a multi-center, prospective, real-world study, aiming to investigate the use of TAF in routine clinical management of chronic hepatitis B patients and evaluate its effectiveness and safety across a heterogeneous population in China. Approximately 500 patients will take part in this study, 10 sites will be included which distribute in China's major cities, thus each site will enroll 50 patients. Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with other HBV antivirals. During 36 months of treatment, efficacy and safety will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males and non-pregnant, non-lactating female patients with HBsAg positive \\> 6 months above 18 years of age; Documented evidence of chronic HBV infection previously; HBV mono-infected HBeAg positive or negative; NA treatment-naive and treatment-experienced; TAF naive; Agree to participate in the study and sign the patient informed consent.\n\nSubjects coinfected with HCV, hepatitis D virus (HDV), human immunodeficiency virus (HIV) or who have received TAF or who haveChild-Pugh C decompensated liver disease or HCC will be excluded.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must have the ability to understand and sign a written informed consent form, consent must be obtained prior to initiation of study procedures\n2. Adult males and nonpregnant, nonlactating females\n3. Documented evidence of chronic HBV infection previously\n4. TAF naive\n\nExclusion Criteria:\n\n1. Patents who were TAF experienced\n2. Women who are breastfeeding\n3. Pregnant females\n4. Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV\n5. Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein (AFP) is \\< 50 ng/mL no imaging study is needed; however, if the screening AFP is \\> 50 ng/mL an imaging study is required)\n6. Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, fatty liver disease, cholangitis)\n7. Current evidence of Child-Pugh Score C decompensated liver disease,or moderate to severe ascites, Grade III-IV hepatic encephalopathy\n8. Abnormal hematological and biochemical parameters, including:\n9. Albumin \\< 2.8 mg/ dL\n10. International normalized ratio (INR) \\> 2.3 X ULN (unless stable on anticoagulant regimen)\n11. Total bilirubin \\> 3 X ULN\n12. Patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity\n13. Received solid organ or bone marrow transplant, except patients who underwent liver or kidney transplantation\n14. Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer). Individuals under evaluation for possible malignancy are not eligible.\n15. Individuals receiving ongoing therapy with drugs not to be used with TAF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients\n16. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements\n17. Use of investigational agents within 3 months of screening, unless allowed by the sponsor\n18. Patients included in another trial or having been given investigational drugs within 12 weeks prior to screening\n19. Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance\n20. Inability or unwillingness to provide informed consent or abide by the requirements of the study\n21. In addition to the above exclusion criteria, patients who meet any of the contraindications for TAF'}, 'identificationModule': {'nctId': 'NCT03752658', 'acronym': 'TRUE', 'briefTitle': 'TAF Real World Study for Universal Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A Real-world Clinical Study on Effectiveness and Safety of Long-term TAF Treatment in Chronic Hepatitis B Patients in China', 'orgStudyIdInfo': {'id': 'IN-US-320-4669'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tenofovir alafenamide (TAF)', 'description': 'Male or female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or treatment-experienced, but TAF naïve will be enrolled in this study, and they will be treated with TAF, alone or in combination with anti-HBV agents.', 'interventionNames': ['Drug: Tenofovir Alafenamide']}], 'interventions': [{'name': 'Tenofovir Alafenamide', 'type': 'DRUG', 'otherNames': ['Vemlidy®'], 'description': 'The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents', 'armGroupLabels': ['Tenofovir alafenamide (TAF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning, Prof.', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '862883662391'}, {'name': 'Qin Ning, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Di Wu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhe Yu', 'role': 'CONTACT'}, {'name': 'Zhe Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shulan(Hangzhou) hospitai', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Nanchang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoping Wu, Doctor', 'role': 'CONTACT'}, {'name': 'Xiaoping Wu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital of Nanchang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Chen', 'role': 'CONTACT'}, {'name': 'Liang Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai public health clinic', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Wuhan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lvye Xu', 'role': 'CONTACT'}, {'name': 'Lvye Xu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital of The Yangtze River Shipping', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youqin Yan', 'role': 'CONTACT'}, {'name': 'Youqin Yan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Seventh Hospital of Wuhan', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xiangya', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Huang', 'role': 'CONTACT'}, {'name': 'Yan Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xiangya Hospital of Central South University', 'geoPoint': {'lat': 24.8453, 'lon': 116.82312}}], 'centralContacts': [{'name': 'Qin Ning, MD., Ph.D.', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+86 278366 2391'}, {'name': 'Di Wu, MD., Ph.D.', 'role': 'CONTACT', 'email': 'woody_1984@163.com', 'phone': '+86 278366 2391'}], 'overallOfficials': [{'name': 'Qin Ning, MD., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department and Institute of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}