RECRUITING Phase 2 ClinicalTrials.gov

Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis

Sponsor: University Hospital, Montpellier • ClinicalTrials.gov ID: NCT07378761

Registry updated: 2026-09-09

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Description

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.

Interventions

UDCA (Ursodeoxycholic acid) (Drug)
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 (Reference Treatment) (Drug)
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.

Eligibility criteria

Inclusion Criteria: * Adults ≥18 years old * Any type of cancer except hepatocellular or cholangiocarcinoma * At least one ICI injection * Cholestatic hepatitis Grade CTC-AE 3 or 4 Exclusion Criteria: * Ongoing corticosteroids treatment * Other causes of hepatitis * Cirrhosis * ICI for hepatocellular carcinoma or cholangiocarcinoma * Biliary obstruction * Medical contraindication to corticosteroids or UDCA * Mixed or hepatocellular hepatitis * Total bilirubin \> 1,5 ULN, Prothrombin rate \< 70% * Medical contraindication to MRI or liver biopsy * Oher serious side effects requiring corticosteroids * Pregnant and breast-feeding patients * Patients under articles L1121-5 to 8 of the public health code * Lack of informed consent * Patients not affiliated with French social security system * Patients uncapable of understanding french

Conditions

Immune-Mediated Cholestasis

Locations

CHU Bordeaux — Bordeaux, France
HCL Croix Rousse — Lyon, France
CHU Montpellier — Montpellier, France
APHP Paul Brousse — Paris, France
CHU Poitiers — Poitiers, France
CHU Toulouse — Toulouse, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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