ClinicaliQ Trial Snapshot
- Drug-induced Liver Injury: Itching Study — Recruiting • Gastroenterology • NCT06446609.
- What is being tested: The study investigates itching (pruritus) associated with drug-induced liver injury (DILI), specifically focusing on cholestatic or mixed-pattern hepatic reactions—an unpredictable adverse response occurring at standard therapeutic drug doses.
- Patient eligibility overview: The trial targets adult patients with confirmed idiosyncratic DILI presenting with pruritus symptoms, likely excluding those with alternative causes of itching such as biliary obstruction or other hepatological conditions.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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).
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.