Liver Disease Itching Study
Research type
Research Study
Full title
Understanding the natural history and impact of itching (pruritus) in patients with drug-induced liver injury (DILI)
IRAS ID
331517
Contact name
Guru Aithal
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
4 years, 0 months, 1 days
Research 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.
Nottingham is the lead UK site for a prospective research study characterising patients with DILI. We have formed a collaborative group of hospitals that are recruiting suspected DILI at onset in the short period available during an acute condition that requires urgent medical attention, with follow-up until resolution. We will similarly embed this study to define the incidence, characteristics, progression and impacts of itching symptoms in DILI. We will collect blood sample for genetic testing to detect genetic variants associated with hereditary cholestatic liver disease.
We plan: recruitment of 60 patients over 2 years with clinical characterisation and follow-up. All will complete a health/quality of life questionnaire and for those who report itching we will request completion of an itching questionnaire at the visit and repeated after 1 week, 1 month, 3 months and 6 months.
The results will be used to assess the burden of itching in this group of patients and potential for future treatment of affected patients.REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/LO/0116
Date of REC Opinion
20 Mar 2024
REC opinion
Further Information Favourable Opinion