Drug-induced Liver Injury: Itching Study
Understanding the Natural History and Impact of Itching (Pruritus) in Patients With Drug-induced Liver Injury (DILI)
University of Nottingham
50 participants
Jun 30, 2025
OBSERVATIONAL
Summary
Idiosyncratic drug-induced liver injury (DILI) is an unpredictable adverse hepatic reaction to a medication used in its therapeutic dose. DILI is the second most common cause of itching in adult Hepatology after biliary obstruction. In particular cholestatic or mixed pattern types of DILI (in which bile flow from the liver is impaired) are associated with long-lasting effects as well as reduced quality of life. There is therefore an urgent need to determine the incidence and natural history of itching in DILI and establish a network of centres that will form a basis for a clinical trial to investigate a novel intervention to treat these.
Eligibility
Inclusion Criteria6
- Age ≥18 (no upper age limit) and able to give informed written consent
- Exposure to potential causal agent and diagnosed with suspected acute DILI defined as meeting one of the following analytical thresholds at enrolment (visit 1):
- alanine transaminase (ALT) ≥5 times upper limit of normal (ULN) or
- alkaline phosphatase ≥2 times ULN or
- ALT ≥3 times ULN plus total bilirubin >2 times ULN
- Results from clinical test samples collected within 36h of visit will be acceptable (as DILI is an acute event, patients are expected to recover or deteriorate quickly so enrolment aligned with diagnostic tests is necessary).
Exclusion Criteria2
- Patients with comorbidities of eczema and urticaria associated with pruritus
- Patients with existing diagnosis of blood-borne viral hepatitis infection (Hepatitis B/C/E)
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Locations(1)
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NCT06446609