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
This trial does not accept healthy volunteersQualifiers
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 population
Patients recruited are those who meet the criteria for DILI, as defined by Aithal et al. (2011) and endorsed by the EASL DILI Guidelines.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence of pruritus (itching) in patients with DILI
To determine the number of participants who have diagnosis of DILI who report pruritus (itching) compared to the number with other acute non-DILI conditions (e.g. autoimmune hepatitis/viral hepatitis) who report itching within a cohort of patients presenting with acute liver injury.
Time frame
2 yearsSecondary outcomes
1
Duration of itching (pruritus) in patients who present with acute liver injury
To determine the duration and re-occurrence of pruritus (itching) symptoms in patients who are diagnosed with DILI and in those with other acute non-DILI conditions. This will entail a repeated questionnaire at study visits and assessment of medical records to report a timescale of symptoms (weeks).
Time frame
4 years2
Severity of itching (pruritus) in patients who present with acute liver injury
To determine the severity of pruritus (itching) symptoms in patients who are diagnosed with DILI and in those with other acute non-DILI conditions. This will entail a repeated questionnaire at study visits to establish the level of itching.
Time frame
4 years3
Genetic variants associated with itching (pruritus) in patients who present with acute liver injury
To determine whether any genetic variants of a 77 gene liver cholestasis panel (including causal variants of progressive familial intrahepatic cholestasis (PFIC)) are associated with pruritus in acute liver injury patients. The study will report presence or absence of genetic markers
Time frame
2.5 years4
Health status reported by patients who present with acute liver injury
To determine the health status reported by patients who are diagnosed with DILI and in those with other acute non-DILI conditions. This will entail a repeated Short Form 36 Health Survey Questionnaire (SF-36) questionnaire at study visits giving a score ranging from 0 to 100. Higher scores indicate better health status.
Time frame
4 yearsSponsors and contacts
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University of Nottingham
Lead sponsor
Ipsen
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov