Nctid:
NCT06221657
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D006506", "term"=>"Hepatitis A"}, {"id"=>"D006509", "term"=>"Hepatitis B"}, {"id"=>"D019337", "term"=>"Hematologic Neoplasms"}, {"id"=>"D006505", "term"=>"Hepatitis"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}], "ancestors"=>[{"id"=>"D008107", "term"=>"Liver Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D006525", "term"=>"Hepatitis, Viral, Human"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D004769", "term"=>"Enterovirus Infections"}, {"id"=>"D010850", "term"=>"Picornaviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D018347", "term"=>"Hepadnaviridae Infections"}, {"id"=>"D004266", "term"=>"DNA Virus Infections"}, {"id"=>"D009371", "term"=>"Neoplasms by Site"}], "browseLeaves"=>[{"id"=>"M9592", "name"=>"Hepatitis A", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M9591", "name"=>"Hepatitis", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M9595", "name"=>"Hepatitis B", "asFound"=>"Hepatitis B", "relevance"=>"HIGH"}, {"id"=>"M21314", "name"=>"Hematologic Neoplasms", "asFound"=>"Hematologic Malignancies", "relevance"=>"HIGH"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "asFound"=>"Blood Disease", "relevance"=>"HIGH"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M9610", "name"=>"Hepatitis, Viral, Human", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M7930", "name"=>"Enterovirus Infections", "relevance"=>"LOW"}, {"id"=>"M13745", "name"=>"Picornaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M20487", "name"=>"Hepadnaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M296", "name"=>"Tenofovir", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-15", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-24", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-12-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Proportion of subjects maintained at HBV DNA <29 IU/mL", "timeFrame"=>"48 weeks"}], "secondaryOutcomes"=>[{"measure"=>"Proportion of subjects maintaining HBV DNA <29 IU/mL", "timeFrame"=>"72 weeks"}, {"measure"=>"Proportion of subjects with serum HBV DNA <60 IU/mL", "timeFrame"=>"12, 24, 48, 72 weeks"}, {"measure"=>"Proportion of subjects maintaining HBV DNA <10 IU/mL", "timeFrame"=>"12, 24, 48, 72 weeks"}, {"measure"=>"Level of AST, ALT, r-GTP", "timeFrame"=>"12, 24, 48, 72 weeks"}, {"measure"=>"total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride", "timeFrame"=>"12, 24, 48, 72 weeks"}, {"measure"=>"level of e-GFR", "timeFrame"=>"12, 24, 48, 72 weeks"}, {"measure"=>"creatinine clearance rate", "timeFrame"=>"12, 24, 48, 72 weeks"}, {"measure"=>"BMD T Score", "timeFrame"=>"24, 48, 72 weeks"}, {"measure"=>"blood Phosphorus levels", "timeFrame"=>"12, 24, 48, 72 weeks"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication"]}, "descriptionModule"=>{"briefSummary"=>"his clinical trial was conducted to determine the non-inferiority and safety of prophylactic antiviral treatment of Tenofovir alafenamide (TAF) compared to Tenofovir disoproxil fumarate (TDF) in patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment. Confirm.\n\nIn the case of TAF, domestic evidence when used as a first-line treatment is insufficient, so in this clinical trial, the virus suppression effect compared to TDF during the first administration of TAF to patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment was investigated. We aim to secure non-inferiority and additionally confirm the safety of TAF's known advantages of reducing renal function damage and protecting bone function."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"19 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Adult men and women over 19 years of age and under 65 years of age\n2. Patients who meet the following criteria A or B A. Those scheduled for hematopoietic stem cell transplantation and treatment with immunosuppressants or chemotherapy.\n\n B. Those scheduled to receive anticancer treatment including rituximab\n3. HBcAb positive patient\n4. Patients who voluntarily agreed to participate in this clinical trial and signed a written consent form\n\nExclusion Criteria:\n\n1. Patients taking oral chronic hepatitis B antiviral drugs before starting the study\n2. Galactose intolerance. Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption\n3. Patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate\n4. Patients with abnormal renal function (e-GFR less than 15mL/min) or end-stage renal disease requiring dialysis\n5. Hepatitis C patients\n6. HIV-infected patients\n7. Pregnant women, lactating women, or patients planning to become pregnant\n8. If you are participating in another clinical trial administering medication\n9. Patients who do not agree to participate in this clinical trial\n10. Adults with impaired consent capacity who are unable to give consent on their own\n11. Those who have taken other clinical trial drugs for less than 24 weeks\n12. Other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial."}, "identificationModule"=>{"nctId"=>"NCT06221657", "briefTitle"=>"Clinical Trial for Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment", "organization"=>{"class"=>"OTHER", "fullName"=>"Yonsei University"}, "officialTitle"=>"A Single-center, Prospective, Randomized, Open-label, Comparative, Investigator-initiated Clinical Trial to Confirm the Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment", "orgStudyIdInfo"=>{"id"=>"IIT-TAF-01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"TAF group", "interventionNames"=>["Drug: Vemlidy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"TDF group", "interventionNames"=>["Drug: Virreal"]}], "interventions"=>[{"name"=>"Vemlidy", "type"=>"DRUG", "description"=>"1 tablet once a day, oral administration", "armGroupLabels"=>["TAF group"]}, {"name"=>"Virreal", "type"=>"DRUG", "description"=>"1 tablet once a day, oral administration", "armGroupLabels"=>["TDF group"]}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Yonsei University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"professor", "investigatorFullName"=>"Hye Won Lee", "investigatorAffiliation"=>"Yonsei University"}}}}
