Understanding itching caused by drug-induced liver injury
Understanding the Natural History and Impact of Itching (Pruritus) in Patients With Drug-induced Liver Injury (DILI)
This study looks at how common itching is for people with drug-induced liver injury to better understand it and help find new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Nottingham) |
| Trial ID | NCT06446609 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with suspected acute drug-induced liver injury.
Not a fit: Patients with pre-existing conditions such as eczema or urticaria associated with pruritus, or those with blood-borne viral hepatitis infections, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment options for patients suffering from itching due to drug-induced liver injury.
How similar studies have performed: While there is limited research specifically targeting itching in DILI, the study's approach to understanding the condition through in-depth phenotyping is innovative and may pave the way for future advancements.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nottingham
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.