[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613485":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":30,"collaborators":19,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":19,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":41,"maxAge":19,"enrollmentInfo":42,"targetDuration":19,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":19,"overallStatus":52,"whyStopped":19,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":19},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Entecavell ODT","EXPERIMENTAL","Entecavir ODT is administered once every day with 0.5mg PO",[13],"Drug: Entecavell ODT",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Entecavir ODT is administered once every day with 0.5mg PO for 48 weeks.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Jongman Kim, Ph, MD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+82-10-9365-0277","jongman94.kim@samsung.com",{"name":22,"role":26,"phone":19,"phoneExt":19,"email":19},{"type":31,"investigatorFullName":32,"investigatorTitle":33,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Jongman Kim","Professor","100613485","phase-2-a-prospective-study-to-evaluate-the-efficacy-and-safety-of-entecavir-odt-conversion-in-stable-liver-transplant-patients-100613485",false,"NCT07267208","A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients","Inclusion Criteria:\n\n1. Patients aged 19 years or older.\n2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:\n\n   1. AST and ALT \\\u003C 35IU\u002FL\n   2. HBsAg: Negative\n   3. HBV DNA: Not detected\n3. Patients who have been taking entecavir for HBV prophylaxis for at least 1 year.\n4. Patients with a tacrolimus trough level maintained between 3-10 ng\u002FmL. 5 .Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.\n\nExclusion Criteria:\n\n1. Patients who have undergone transplantation of organs other than the liver or re-transplantation.\n2. Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.\n3. Patients with concurrent viral infections (HCV, HIV).\n4. Patients with eGFR \\\u003C30 or those undergoing dialysis\n5. Pregnant or breastfeeding women.\n6. Patients or their spouses\u002Fpartners who do not agree to use medically acceptable and appropriate contraception methods\\* during the clinical trial period.\n\n   \\* Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide.\n7. Patients with a history of hypersensitivity to Entecavir.\n8. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.","ALL","19 Years",{"count":43,"type":44},82,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","This clinical study aims to evaluate the efficacy and safety of switching to entecavir orally disintegrating tablets (ETV-ODT) in liver transplant recipients with chronic hepatitis B, with a particular focus on the impact of the conversion on renal function.\n\nAfter providing written informed consent, participants will undergo screening assessments to determine eligibility based on the inclusion and exclusion criteria. Eligible participants who receive the investigational product will visit the study site at predetermined time points over a 48-week period to complete the scheduled study procedures.",[50,51],"Hepatitis B Virus","Liver Transplant","NOT_YET_RECRUITING","2025-11-24",{"date":55,"type":56},"2025-12-05","ACTUAL",{"date":58,"type":44},"2025-12-01",{"date":60,"type":44},"2027-12-31",{"name":32,"class":6}]