Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UDCA (Ursodeoxycholic acid), Corticosteroids (Reference Treatment).
- Who it may be relevant to
- Registry conditions: Immune-Mediated Cholestasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial
Overview
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
- Drug UDCA (Ursodeoxycholic acid)
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. - Drug Corticosteroids (Reference Treatment)
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.
Primary outcome measures
- Improvement of at least 25% in liver function tests on day 21 after randomization [Time frame: 21 days after randomization]
Secondary outcome measures (4)
- Rate of Hepatitis Resolution at 6 Months [Time frame: 6 Months after randomization]
- Time to Hepatitis Resolution [Time frame: From Randomization to end of follow-up at 12 months]
- Tolerance to UDCA and/or Corticosteroids [Time frame: From treatment initiation following the randomization to end of follow-up at 12 months]
- Resumption of immunotherapy [Time frame: Within 12 months after randomization]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 6 centers
- CHU Bordeaux — Bordeaux
- HCL Croix Rousse — Lyon
- CHU Montpellier — Montpellier
- APHP Paul Brousse — Paris
- CHU Poitiers — Poitiers
- CHU Toulouse — Toulouse
Identifiers
NCT: NCT07378761 · RECHMPL24_0328 · 2025-521317-50-00