[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-mediated-cholestasis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-mediated-cholestasis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100622064","phase-2-comparing-udca-and-corticosteroids-in-immunotherapy-induced-cholestatic-hepatitis-100622064",false,"NCT07378761","Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis","Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial","CHILURSO","Inclusion Criteria:\n\n* Adults ≥18 years old\n* Any type of cancer except hepatocellular or cholangiocarcinoma\n* At least one ICI injection\n* Cholestatic hepatitis Grade CTC-AE 3 or 4\n\nExclusion Criteria:\n\n* Ongoing corticosteroids treatment\n* Other causes of hepatitis\n* Cirrhosis\n* ICI for hepatocellular carcinoma or cholangiocarcinoma\n* Biliary obstruction\n* Medical contraindication to corticosteroids or UDCA\n* Mixed or hepatocellular hepatitis\n* Total bilirubin \\> 1,5 ULN, Prothrombin rate \\\u003C 70%\n* Medical contraindication to MRI or liver biopsy\n* Oher serious side effects requiring corticosteroids\n* Pregnant and breast-feeding patients\n* Patients under articles L1121-5 to 8 of the public health code\n* Lack of informed consent\n* Patients not affiliated with French social security system\n* Patients uncapable of understanding french","ALL","18 Years",{"count":20,"type":21},94,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The clinical trial aims to compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period.\n\nThe trial presents a detailed scientific justification for comparing UDCA to corticosteroids, describing the treatment and detailing the follow-up procedures. It hypothesizes that UDCA could be superior to corticosteroids for treating ICI-related cholestatic hepatitis, based on its established use in primary biliary cholangitis and a favorable tolerance profile compared to corticosteroids.",[27],"Immune-Mediated Cholestasis",[29,30,31,32],"DILI","Immune checkpoint inhibitors","Cancer","Cholestatic hepatitis","NOT_YET_RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":21},"2026-12",{"date":41,"type":21},"2029-08",{"name":43,"class":44},"University Hospital, Montpellier","OTHER",6]