[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496469":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":76,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":10,"enrollmentInfo":91,"targetDuration":10,"studyType":94,"phases":10,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":34,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Chiesi Hungary Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Liver transplant patients, receiving tacrolimus containing immunosuppression",null,"1. Patients ≥ 18 years of age\n2. Patients after liver- or simultaneous liver and kidney transplantation\n3. Having received a tacrolimus containing immunosuppressant therapeutic regimen at least for four weeks (induction therapy), and TL is within 5-20 ng\u002Fml before inclusion. Possible medications are the following (dosages and administration according to local (European) SmPC\n\n   * Envarsus prolonged release tablet\n   * Adport hard capsule\n   * Advagraf prolonged-release hard capsule\n   * Modigraf granule for oral suspension\n   * Prograf hard capsule\n   * Tacforius hard capsule",[13],"Drug: Tacrolimus",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Tacrolimus","Tacrolimus received as part of routine clinical care",[9],[21],{"name":22,"affiliation":23,"role":24},"László Piros, MD, PhD","Semmelweis University, Department of Surgery, Transplantation and Gastroenterology, Budapest, Hungary","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":10,"email":30},"Ákos Szeredi, MD","CONTACT","+36707772232","a.szeredi@chiesi.com",[32,54],{"facility":33,"status":34,"city":35,"state":10,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Semmelweis University, Department of Surgery, Transplantation and Gastroenterology","RECRUITING","Budapest","1085","Hungary","HU",{"type":40,"coordinates":41},"Point",[42,43],19.04045,47.49835,{"lat":43,"lon":42},[46,49,52],{"name":22,"role":28,"phone":47,"phoneExt":10,"email":48},"+36300905499","drpiroslaszlo@gmail.com",{"name":50,"role":51,"phone":10,"phoneExt":10,"email":10},"Tamás Benkő, MD, PhD","SUB_INVESTIGATOR",{"name":53,"role":51,"phone":10,"phoneExt":10,"email":10},"Anita Haboub Sandil, MD",{"facility":55,"status":34,"city":56,"state":10,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University Medical Center Ljubljana, Division of Internal Medicine, Department of Gastroenterology","Ljubljana","1000","Slovenia","SI",{"type":40,"coordinates":61},[62,63],14.50513,46.05108,{"lat":63,"lon":62},[66,68,70,72,74],{"name":67,"role":28,"phone":10,"phoneExt":10,"email":10},"Marija Ribnikar, MD, PhD",{"name":69,"role":51,"phone":10,"phoneExt":10,"email":10},"Katja Novak, MD",{"name":71,"role":51,"phone":10,"phoneExt":10,"email":10},"Jan Drnovsek, MD",{"name":73,"role":51,"phone":10,"phoneExt":10,"email":10},"Anja Rihtarsic, MD",{"name":75,"role":51,"phone":10,"phoneExt":10,"email":10},"Marjana Turk Jerovsek, MD",{"type":77,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[79],{"name":80,"class":6},"Chiesi Slovenija, d.o.o.","100496469","assessment-of-the-pharmacokinetic-profile-of-tacrolimus-medications-and-their-relation-to-effectiveness-and-safety-in-liver-transplant-patients-100496469",false,"NCT05744635","Assessment of the Pharmacokinetic Profile of Tacrolimus Medications and Their Relation to Effectiveness and Safety in Liver Transplant Patients","Assessment of the Pharmacokinetic Profile of Tacrolimus Medications in Liver Transplant Patients","LTA","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age\n2. Patients after liver- or simultaneous liver and kidney transplantation\n3. Having received a tacrolimus containing immunosuppressant therapeutic regimen at least for four weeks (induction therapy), and TL is within 5-20 ng\u002Fml before inclusion\n4. Patients signed an informed consent form for use of their pseudonymised clinical data within the present non-interventional trial.\n\nExclusion Criteria:\n\n1. Participation in any clinical trial, 30 days prior to inclusion\n2. The patients received liver allograft more than 6 months before inclusion\n3. Hospitalisation due to infection, acute rejection, or graft disfunction 2 weeks prior to enrolment\n4. Chronic graft insufficiency in the patient's history\n5. Use of medications 2 weeks prior to enrolment, or the need for continuous use of medications that are known to significantly affect the pharmacokinetics of tacrolimus containing medications (as CYP3A4 inducers: rifampin, carbamazepine, phenobarbital, and phenytoin, or CYP3A4 inhibitors: erythromycin, ketoconazole, clarithromycin, and verapamil containing medication)\n6. Presence of the following comorbidities:\n\n   1. Diseases affecting adherence to therapy (Chronic neurologic conditions, Psychiatric diseases)\n   2. Diseases affecting drug absorption and metabolism (Inflammatory bowel disease, Chronic inflammatory diseases of bile ducts, Presence of ascites due to any disease)\n7. Patients on waiting list for re-transplantation","ALL","18 Years",{"count":92,"type":93},110,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is oo compare the pharmacokinetic parameters of different tacrolimus containing medications in liver transplant patients. The main question\\[s\\] it aims to answer are:\n\n* Differences in pharmacokinetic parameters of tacrolimus containing medicinal products (TL, TDD and their ratio - C\u002FD)\n* Changes in liver function parameters compared to baseline.\n* Change in the estimated glomerular filtration rate (eGFR) compared to baseline.\n* To assess the possible relation of liver function parameters and eGFR to C\u002FD (blood concentration and daily dosage)\n* Incidence of acute graft rejection during the study\n* Incidence of BK and cytomegalovirus (CMV) infection during the study\n* To assess the intraindividual variability of the TL, TDD and the ratios of these parameters (C\u002FD)\n* To assess the patient-adherence of therapy based on the BAASIS questionnaire, and prescription filled by individual patients, based on electronic health-care record.\n\nParticipants will not have to undergo any additional clinical visits or tests except which are required in routine clinical care",[97],"Liver Failure",[99,100,17],"Liver transplantation","Immunosuppression","2024-08-21",{"date":103,"type":104},"2024-08-22","ACTUAL",{"date":106,"type":104},"2023-05-10",{"date":108,"type":93},"2026-06-01",{"name":5,"class":6},2]