Understanding itching caused by drug-induced liver injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the incidence and natural history of itching associated with drug-induced liver injury (DILI). It focuses on patients diagnosed with suspected acute DILI and seeks to gather in-depth phenotyping data to better understand the contributing factors to this condition. The study will establish a network of centers to facilitate future clinical trials aimed at developing novel interventions for treating DILI-related itching. By analyzing various patient characteristics and their responses, the research hopes to refine treatment approaches for this unpredictable adverse reaction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 (no upper age limit) and able to give informed written consent
* Exposure to potential causal agent and diagnosed with suspected acute DILI defined as meeting one of the following analytical thresholds at enrolment (visit 1):

  * 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

Results from clinical test samples collected within 36h of visit will be acceptable (as DILI is an acute event, patients are expected to recover or deteriorate quickly so enrolment aligned with diagnostic tests is necessary).

Exclusion Criteria:

* Patients with comorbidities of eczema and urticaria associated with pruritus
* Patients with existing diagnosis of blood-borne viral hepatitis infection (Hepatitis B/C/E)

Where it's running

• Nottingham University Hospitals NHS Trust
  Nottingham, United Kingdom Recruiting

Study contacts

• Study coordinator: Elinor Study Coordinator
• Email: Elinor.Cross@nottingham.ac.uk
• Phone: 0115 7484390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.