Immune-Mediated Hepatitis Clinical Trial
Official title:
Checkpoint Inhibitor-induced Liver Injury Study (ChILI)
In this multi-center prospective observational study, the investigators plan to identify the incidence and risk factors for checkpoint inhibitor-induced liver injury and characterize biochemical, genetic, immunological, and histological features associated with it.
Checkpoint inhibitor-induced liver injury (ChILI) is a new incompletely understood category of hepatotoxicity which is distinct from other types of drug-induced liver injury (DILI) such as direct or idiosyncratic DILI. The data regarding the incidence and risk factors is lacking. Therefore, 'in-depth phenotyping' together with data from the control group exposed to checkpoint inhibitors (CPI) is necessary to develop refined algorithms incorporating CPI-related factors, host genetic and environmental risk factors that would enable pre-empting ChILI. The aim of the study is to enroll two deeply phenotyped cohorts (patients who developed ChILI and patients who are starting checkpoint inhibitors) and obtain biological samples at multiple time points. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05484908 -
Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC
|
N/A |