NCT04476563

Checkpoint Inhibitor-induced Liver Injury

Checkpoint Inhibitor-induced Liver Injury Study (ChILI)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Immune-Mediated Hepatitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Obtaining biological samples	Biological samples (blood, urine, stool). Liver tissue will be obtained from ChILI group when clinically indicated

Timeline

• Start date: 2020-10-13
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2020-07-20
• Last updated: 2026-03-24

Locations

1 site across 1 country: United Kingdom