Actively Recruiting

Age: 18Years +
All Genders
NCT06446609

Drug-induced Liver Injury: Itching Study

Led by University of Nottingham · Updated on 2026-04-30

50

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

Sponsors

U

University of Nottingham

Lead Sponsor

I

Ipsen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Drug-induced Liver Injury: Itching Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 or older and able to give informed written consent
  • Exposure to a potential causal agent and diagnosed with suspected acute DILI defined by one of the following at enrollment: alanine transaminase (ALT) 5 times upper limit of normal (ULN) or alkaline phosphatase 2 times ULN or ALT 3 times ULN plus total bilirubin over 2 times ULN
  • Clinical test results within 36 hours of enrollment visit acceptable
Not Eligible

You will not qualify if you...

  • Patients with eczema or urticaria causing itching
  • Patients with diagnosed blood-borne viral hepatitis infection (Hepatitis B, C, or E)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Actively Recruiting

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Research Team

E

Elinor Study Coordinator

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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