Actively Recruiting
Checkpoint Inhibitor-induced Liver Injury
Led by University of Nottingham · Updated on 2026-03-24
160
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
Sponsors
U
University of Nottingham
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Checkpoint Inhibitor-induced Liver Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give written informed consent OR have a personal or nominated consultee if unable due to encephalopathy from ChILI
- Patients who developed checkpoint inhibitor-induced liver injury meeting one of the following at enrollment: ALT >5 times upper limit of normal (ULN), OR ALT >3 times ULN plus bilirubin >2 times ULN, OR ALP >2 times ULN with elevated gamma-glutamyl transferase without bone metastases
- No other known causes of liver injury after thorough investigations
- Consecutive cancer patients with clinical indication to start checkpoint inhibitors (control group)
You will not qualify if you...
- Patients treated with cytotoxic chemotherapy concurrently with checkpoint inhibitors
- Patients judged by chief investigator to have alternative explanations for acute liver injury other than ChILI
- Patients who developed ChILI but did not meet the specified liver enzyme criteria or were found to have other causes after investigations
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Nottingham
Nottingham, United Kingdom, NG72RD
Actively Recruiting
Research Team
G
Guruprasad Padur Aithal, MBBS, FRCP, PhD
CONTACT
E
Edmond Atallah, M.D, MRCP(UK)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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