Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

Checkpoint Inhibitor-induced Liver Injury

Sponsor: University of Nottingham

NCT ID: NCT04476563

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Obtaining biological samples (diagnostic test)
How long the study runs
Study runs about 68 months (dates as stated)
About the drug or intervention
Obtaining biological samples — diagnostic test: Biological samples (blood, urine, stool).
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
160
Started
2020-10-13
Last checked
2025-09

Plain English Summary

What is this study?

  • • Testing a new treatment for immune-mediated hepatitis
  • • Clinical study - 160 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with immune-mediated hepatitis

Where?

  • • Nottingham - University of Nottingham

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Immune-Mediated Hepatitis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Both patient groups and control group:
  • ✓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 (liver enzymes) exceeding 5 times the upper limit of normal (ULN) OR

Who cannot take part

  • ✗Patients who are treated with cytotoxic drug treatment concurrently with checkpoint inhibitors.
  • ✗On the judgment of chief investigator that the person has certain alternative explanations to the acute event...
See the full criteria
Inclusion Criteria: 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: 1. 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 2. 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 Criteria: * 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).

Where Is This Study? (1 UK site)

University of Nottingham

Nottingham NG72RD, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Guruprasad Padur Aithal, MBBS, FRCP, PhD

Sponsor contact

CONTACT

0115 823 1074 guru.aithal@nottingham.ac.uk

Edmond Atallah, M.D, MRCP(UK)

Sponsor contact

CONTACT

edmond.atallah@nottingham.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-09