NCT04476563 Checkpoint Inhibitor-induced Liver Injury
| NCT ID | NCT04476563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Immune-Mediated Hepatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2020-10-13 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2020-10-13 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, genetic, immunological, and histological features associated with it.
Eligibility 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04476563 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune-Mediated Hepatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04476563 currently recruiting?
Yes, NCT04476563 is actively recruiting participants. Contact the research team at guru.aithal@nottingham.ac.uk for enrollment information.
Where is the NCT04476563 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT04476563 clinical trial?
NCT04476563 is sponsored by University of Nottingham. The trial plans to enroll 160 participants.