Status:
RECRUITING
Checkpoint Inhibitor-induced Liver Injury
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Pfizer
Conditions:
Immune-Mediated Hepatitis
Eligibility:
All Genders
18+ years
Brief 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, gene...
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 i...
Eligibility Criteria
Inclusion
- Both patient groups and control group:
- • Able to give written informed consent OR Potential participants who have developed encephalopathy related to ChILI as a response to checkpoint inhibitor therapy, who lack the capacity to give written informed consent and have a consultee (personal or nominated) - for ChILI patient group only
- ChILI group:
- Patients who developed checkpoint inhibitor-induced liver injury and meet the following criteria:
- Meets one of the following analytical thresholds at enrolment (visit 1)
- Alanine transaminase (ALT) exceeding 5 times the upper limit of normal (ULN) OR
- ALT exceeding 3 times ULN plus bilirubin exceeding 2 times ULN OR
- Alkaline phosphatase (ALP) exceeding 2 times ULN with accompanying elevations of gamma-glutamyl transferase in the absence of known bone metastases driving the rise in ALP level
- Absence of other known causes of liver injury after detailed investigations
- Patients who developed ChILI but did not meet the above criteria at enrolment or who were found to have a different cause for their liver injury after further investigations will be excluded from the analysis
- Control group:
- Consecutive patients with cancer who have a clinical indication to start checkpoint inhibitors. A small proportion of patients will develop ChILI following their checkpoint inhibitor treatment and will be classified as cases.
Exclusion
- Patients who are treated with cytotoxic chemotherapy concurrently with checkpoint inhibitors.
- On the judgment of chief investigator that the person has certain alternative explanations to the acute event (rather than ChILI).
Key Trial Info
Start Date :
October 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04476563
Start Date
October 13 2020
End Date
December 1 2025
Last Update
September 29 2025
Active Locations (1)
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1
University of Nottingham
Nottingham, United Kingdom, NG72RD