Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis (NCT07378761) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Comparing UDCA and Corticosteroids in Immunotherapy Induced Cholestatic Hepatitis
France94 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of at least 25% in liver function tests on day 21 after randomization