NCT06446609 Drug-induced Liver Injury: Itching Study
| NCT ID | NCT06446609 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Nottingham |
| Condition | Drug Induced Liver Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-06-30 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06446609 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Induced Liver Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06446609 currently recruiting?
Yes, NCT06446609 is actively recruiting participants. Contact the research team at Elinor.Cross@nottingham.ac.uk for enrollment information.
Where is the NCT06446609 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom.
Who is sponsoring the NCT06446609 clinical trial?
NCT06446609 is sponsored by University of Nottingham. The trial plans to enroll 50 participants.