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CHILURSO: Efficacy of Ursodeoxycholic Acid versus Corticosteroids for the Treatment of Cholestatic Hepatitis Secondary to Immunotherapy
EU CTIS ID: 2025-521317-50-00
What this study is testing
Compare the effectiveness of ursodeoxycholic acid (UDCA) to corticosteroids in treating cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs) over a 21-day period.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults, 18 years old with any type of cancer except hepatocellular or cholangiocarcinoma
- Any therapeutic line (adjuvant or palliative), at least one ICI injection
- cholestatic hepatitis R≤ 2 (R=ratio (ALT/ULN) /(PAL/ULN)) , Grade CTC-AE 3 or 4.
- Women of childbearing age using an appropriate contraceptive method throughout the entire duration of the treatment
You likely can't join if
- Ongoing corticosteroids treatment
- Pregnant and breastfeeding patients
- other causes of hepatitis, cirrhosis
- ICI for hepatocellular carcinoma or cholangiocarcinoma
- biliary obstruction
- medical contraindication to corticosteroids or UDCA medical contraindication to MRI or liver biopsy
See the full eligibility criteria
- Adults, 18 years old with any type of cancer except hepatocellular or cholangiocarcinoma
- Any therapeutic line (adjuvant or palliative), at least one ICI injection
- cholestatic hepatitis R≤ 2 (R=ratio (ALT/ULN) /(PAL/ULN)) , Grade CTC-AE 3 or 4.
- Women of childbearing age using an appropriate contraceptive method throughout the entire duration of the treatment
- Ongoing corticosteroids treatment
- Pregnant and breastfeeding patients
- other causes of hepatitis, cirrhosis
- ICI for hepatocellular carcinoma or cholangiocarcinoma
- biliary obstruction
- medical contraindication to corticosteroids or UDCA medical contraindication to MRI or liver biopsy
- mixed or hepatocellular hepatitis,
- total bilirubin > 1,5 ULN, prothrombin rate < 70%
- other serious side effects requiring corticosteroids
- patients under articles L1121-5 to 8 of the public health code, lack of informed consent, patients not affiliated with French social security system and patients uncapable of understanding/ reading/ writing in french
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.