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Drug-induced Liver Injury: Itching Study

RecruitingN/A

Sponsor: University of Nottingham

Conditions: Drug Induced Liver Injury, Pruritus

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Patients with comorbidities of eczema and urticaria associated with pruritus
* Patients with existing diagnosis of blood-borne viral hepatitis infection (Hepatitis B/C/E)

Locations (1)

Nottingham, United Kingdom