Drug-induced Liver Injury: Itching Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Nottingham

About this trial

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 criteria

Qualifiers

Age ≥18 (no upper age limit) and able to give informed written consent

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

Disqualifiers

Patients with comorbidities of eczema and urticaria associated with pruritus

Patients with existing diagnosis of blood-borne viral hepatitis infection (Hepatitis B/C/E)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

University of Nottingham

Lead sponsor

Ipsen

Collaborator

National Institute for Health Research, United Kingdom

Collaborator

Nottingham University Hospitals NHS Trust

Collaborator