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Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis

RecruitingPhase 2Ages 18 Years - anyAllUniversity Hospital, Montpellier
NCT07378761 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

6 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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