A Phase 2 interventional study of UDCA (Ursodeoxycholic acid) and Corticosteroids (Reference Treatment) in Immune-Mediated Cholestasis, sponsored by University Hospital, Montpellier. Recruiting at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University Hospital, Montpellier · Phase 2, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 94 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Patients randomized to the experimental arm will receive ursodeoxycholic acid (UDCA) as initial treatment for hepatitis. After evaluation of the primary endpoint at Day 21, UDCA treatment will be continued for a total duration of 6 months. In case of lack of response to UDCA, patients will continue UDCA and will additionally receive corticosteroids which represent the reference treatment.
Drug: UDCA (Ursodeoxycholic acid)
Patients randomized to the control arm will receive the reference treatment, corticosteroids. Corticosteroids will be given at a dose of 0.5-1 mg/kg/day for 21 days, followed by tapering in weekly steps of 10 mg until treatment discontinuation. At Day 21, in case of lack of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroid tapering will continue, and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day.
Drug: Corticosteroids (Reference Treatment)
Ursodeoxycholic acid (UDCA) will be administered orally at an initial dose of 13-15 mg/kg/day, divided into two daily doses. After assessment of the primary endpoint at Day 21, UDCA will be continued for a total treatment duration of 6 months. In case of absence of treatment response, defined as no decrease of alkaline phosphatase and/or gamma-glutamyl transferase levels of at least 25% compared with baseline, corticosteroids which represent the reference treatment, will be added at a dose of 0.5-1 mg/kg.
Corticosteroids will be administered orally at a dose of 0.5-1 mg/kg/day for 21 days, followed by a tapering schedule of 10 mg per week until treatment discontinuation. At Day 21, if there is no adequate response (defined as less than 25% decrease in alkaline phosphatase and/or gamma-glutamyl transferase from baseline), the corticosteroid taper will continue and ursodeoxycholic acid (UDCA) will be added at a dose of 13-15 mg/kg/day.
Improvement of at least 25% in liver function tests on day 21 after randomization
The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) on Day 21 after randomization.
Time frame: 21 days after randomization
Rate of Hepatitis Resolution at 6 Months
Rate of patients with resolution of hepatitis, defined as hepatitis grade ≤ 1 according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), at 6 months after randomization.
Time frame: 6 Months after randomization
Time to Hepatitis Resolution
Time to hepatitis resolution, defined as the time from the date of randomization to the date of hepatitis resolution (grade ≤ 1). Hepatitis severity will be graded according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: From Randomization to end of follow-up at 12 months
Tolerance to UDCA and/or Corticosteroids
Tolerance to ursodeoxycholic acid (UDCA) and/or corticosteroids will be evaluated through the assessment of adverse events. Adverse events will be collected throughout the study and graded according to the current National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: From treatment initiation following the randomization to end of follow-up at 12 months
Resumption of immunotherapy
Rate of patients in whom resumption of immunotherapy was possible after hepatitis within 12 months after randomization
Time frame: Within 12 months after randomization
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University Hospital, Montpellier