Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07378761
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07378761
Study Brief:
Protocol Section:
NCT07378761