Cholestatic hepatitis induced by immune checkpoint inhibitors (ICIs)
Conditions
Brief summary
The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) from baseline on Day 21.
Detailed description
Rate of patients with resolution of hepatitis, i.e., grade ≤ 1 according to the current NCI CTC-AE classification, at 6 months after randomization, the time to hepatitis resolution (grade ≤ 1) defined as the time from the date of randomization to the date of resolution of hepatitis, the tolerance to UDCA or corticosteroids or both: Adverse events assessed according to the current NCI-CTC AE classification, Factors associated with response to UDCA at D21 among the immunotherapy molecule, duration of ICI treatment, presence or absence of bile duct dilation, tumor histology, Rate of patients in whom resumption of immunotherapy was possible after hepatitis within 12 months after randomization
Interventions
Sponsors
Centre Hospitalier Universitaire De Montpellier
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of patients showing an improvement of at least 25% in liver function tests (alkaline phosphatase and/or gamma-GT) from baseline on Day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of patients with resolution of hepatitis, i.e., grade ≤ 1 according to the current NCI CTC-AE classification, at 6 months after randomization, the time to hepatitis resolution (grade ≤ 1) defined as the time from the date of randomization to the date of resolution of hepatitis, the tolerance to UDCA or corticosteroids or both: Adverse events assessed according to the current NCI-CTC AE classification, Factors associated with response to UDCA at D21 among the immunotherapy molecule, duration of ICI treatment, presence or absence of bile duct dilation, tumor histology, Rate of patients in whom resumption of immunotherapy was possible after hepatitis within 12 months after randomization | — |
Countries
France
Outcome results
None listed