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
Sponsors and collaborators
University of Nottingham
Lead sponsor
Ipsen
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator