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ClinicalTrials.gov ID

NCT07378761

Lead Sponsor

University Hospital, MontpellierOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

94Estimated

Last Update Posted

Jun 18, 2026Actual

Start Date

Dec 2026Estimated

Primary Completion Date

Sep 2028Estimated

Completion Date

Aug 2029Estimated

Official Title

Efficacy of Ursodeoxycholic Acid Versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy: A Multicenter, Controlled, Randomized, Open Trial

Brief 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.

• Immune-Mediated Cholestasis

• UDCA (Ursodeoxycholic acid)
• Corticosteroids (Reference Treatment)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, MontpellierOTHER

lucy.meunier@chu-montpellier.fr+33467330224