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Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis

Study acronym: CHILURSO
StatusRecruiting
PhasePhase 2
Started2026-06-25
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Status, Contacts/Locations v2
Recruitment opened
Primary completion moved earlier: 2028-09 → 2028-01
Completion moved earlier: 2029-08 → 2028-12
Start dateestimated 2026-12→confirmed 2026-06-25
Study sitesdetails revised at 6 of 6 sites
2026-06-17
Study Status v1
Primary completion pushed: 2027-09 → 2028-09
Completion pushed: 2028-08 → 2029-08
Start date2026-02→2026-12
2026-01-22
Original filing
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.
Trial Details
NCT Number NCT07378761
Lead Sponsor University Hospital, Montpellier
Conditions Immune-Mediated Cholestasis
Enrollment 94 participants
Start Date 2026-06-25
Primary Completion 2028-01 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-09