Understanding the Natural History and Impact of Itching (Pruritus) in Patients With Drug-induced Liver Injury (DILI)

What this Trial Is About

Drug-induced liver injury (DILI) is an unpredictable adverse reaction to medications taken at therapeutic doses, often causing itching and impacting quality of life. This study focuses on the itching (pruritus) associated with cholestatic or mixed patterns of DILI, which can cause long-lasting effects. Researchers aim to better understand the incidence, natural history, and impact of itching in patients with DILI and to establish a network of centers for future clinical trials of new treatments. The study is observational and will track patients diagnosed with suspected acute DILI based on specific liver enzyme and bilirubin levels. It will gather detailed information on itching symptoms, genetic factors, and health status over several years. No investigational treatments are administered; instead, the study collects data to help identify which patients might benefit from future therapies. Participants will be monitored for up to four years with regular assessments of itching incidence, duration, severity, and genetic analysis. Patient-reported health status is also recorded to understand quality of life impacts. The primary outcome is the incidence of itching over two years. Safety and health monitoring continue throughout the study duration, with the total participation period lasting up to four years.

Drug-induced Liver Injury: Itching Study