Checkpoint Inhibitor-induced Liver Injury
ConditionImmune-Mediated Hepatitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Nottingham
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Obtaining biological samples
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Nottingham
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov