Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
HCL Croix Rousse
RECRUITING
Lyon
CHU Montpellier
RECRUITING
Montpellier
APHP Paul Brousse
NOT_YET_RECRUITING
Paris
CHU Poitiers
NOT_YET_RECRUITING
Poitiers
CHU Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Dr. MEUNIER
lucy.meunier@chu-montpellier.fr
+33467330224
Time Frame
Start Date:2026-06-25
Estimated Completion Date:2028-12
Participants
Target number of participants:94
Treatments
Experimental: Experimental arm
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.
Active_comparator: Control arm
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.