Drug-induced Liver Injury: Itching Study

Launched by UNIVERSITY OF NOTTINGHAM · Jun 4, 2024

Keywords

ClinConnect Summary

The "Drug-induced Liver Injury: Itching Study" is researching how certain medications can cause liver injury and associated itching, which can significantly affect a person's quality of life. This study aims to understand how common itching is in patients with drug-induced liver injury (DILI) and to establish a network of centers that can help test a new treatment for this condition. DILI can occur unexpectedly when someone takes a medication, and in some cases, it leads to serious itching due to problems with bile flow from the liver.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with suspected acute liver injury linked to a medication. This diagnosis is based on specific lab test results that show liver enzyme levels are significantly elevated. However, individuals with certain skin conditions, such as eczema or urticaria, or those with existing viral hepatitis, won't be eligible. Participants can expect to undergo various assessments to understand their condition better and may have the opportunity to contribute to important research that could lead to new treatment options for itching caused by liver injury.

Gender

ALL

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)