Clinical Trial

Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis

Study acronym: CHILURSO
Not Yet Recruiting Phase 2
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Summary
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. The 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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2027-09 -> 2028-09 2026-06-19
minor Completion pushed: 2028-08 -> 2029-08 2026-06-19
Trial Details
NCT Number NCT07378761
Lead Sponsor University Hospital, Montpellier
Conditions Immune-Mediated Cholestasis
Enrollment 94 participants
Start Date 2026-12
Primary Completion 2028-09 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-06-18