[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585645":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":20,"locations":40,"responsibleParty":62,"collaborators":20,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":20,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":43,"whyStopped":20,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Individuals who underwent liver transplantation for primary sclerosing cholangitis 1-7 years before study initiation, and meeting study criteria, will receive fenofibrate 160mg oral daily for 36 months\n\nParticipants will undergo the following serum assessments as part of the study every 3 months during the study period: total bile acids, bile acid profile, fibroblast growth factor 19, and 7-alpha-C4\n\nParticipants will undergo gadoxate-enhanced magnetic resonance imaging at baseline, 12 months, and 36 months.",[13,14,15],"Drug: Fenofibrate (drug)","Diagnostic Test: Blood draw for the laboratory assessment","Diagnostic Test: MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)",{"label":17,"type":18,"description":19,"interventionNames":20},"Historical control","NO_INTERVENTION","Historical control of individuals who underwent liver transplantation for primary sclerosing cholangitis who were not treated with any peroxisome proliferator activated receptor agonist treatment.",null,[22,27,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":20},"DRUG","Fenofibrate (drug)","Once daily fenofibrate for 36 months",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":20},"DIAGNOSTIC_TEST","Blood draw for the laboratory assessment","Serum assessments will be performed every 3 months during the study period",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":20},"MRI using a hepatobiliary phase contrast agent (Gd-EOB-DPTA)","Participants will undergo a quantitative gadoxetate-enhanced MRI and MRCP at baseline, and at 12 months and 36 months of trial participation.",[9],[37],{"name":38,"affiliation":5,"role":39},"Channa Jayasekera","PRINCIPAL_INVESTIGATOR",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Mayo Clinic in Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-111.89903,33.50921,{"lat":53,"lon":52},[56,61],{"name":57,"role":58,"phone":59,"phoneExt":20,"email":60},"Han Ly","CONTACT","480-574-2321","ly.ngochan@mayo.edu",{"name":38,"role":39,"phone":20,"phoneExt":20,"email":20},{"type":39,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Channa R Jayasekera, MD, MSc","Principal Investigator","100585645","phase-2-pharmacologic-approaches-to-preventing-primary-sclerosing-cholangitis-recurrence-after-liver-transplantation-100585645",false,"NCT06905054","Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Inclusion criteria:\n\n* Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment\n* Absence of rPSC at time of study enrollment\n* At least one of the following additional features that increase risk of rPSC\n\n  * LT performed for cholangiocarcinoma\n  * Concurrent inflammatory bowel disease\n  * Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment\n  * Any episode of acute cellular rejection in the post-transplant period before the study enrollment\n* If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) inclusion criteria to expand enrollment to any patient meeting the other inclusion\u002Fexclusion criteria.\n* Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and\u002For are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost.\n\nExclusion criteria:\n\n* Presence of ischemic cholangiopathy which can mimic rPSC\n* LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis\n* Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC\n* History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC\n* Baseline GFR \\\u003C30 ml\u002Fmin which precludes administration of fenofibrate\n* Previously known intolerance or allergy to fenofibrate\n* Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment\n* Female participants that are pregnant or planning to become pregnant","ALL","18 Years","75 Years",{"count":76,"type":77},80,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with",[83,84,85,86],"Primary Sclerosing Cholangitis","Liver Transplant, Complications","PSC","Biliary Strictures",[88,89,90,91,92,93,94],"primary sclerosing cholangitis","recurrent primary sclerosing cholangitis","liver transplant complication","fenofibrate","fibrate","PPAR agonist","peroxisome proliferated activated receptor agonist","2025-06-25",{"date":97,"type":98},"2025-06-27","ACTUAL",{"date":100,"type":98},"2025-04-15",{"date":102,"type":77},"2028-07-01",{"name":5,"class":6},1]