Status: Not yet recruiting
Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis
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.
Participants needed: 94
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: University Hospital, MontpellierUpdated: Jun 18, 2026Locations: 6
Eligibility criteria
Adults ≥18 years old [+3]
Ongoing corticosteroids treatment [+14]