NCT04526548

A Diagnostic Study on Patients With Drug-induced Liver Injury

A Multi-center, Prospective Cohort Study on the Diagnostic Value and Prognostic Factors of the RUCAM Scale in Patients With Acute Drug-induced Liver Injury Based on Chronic Liver Disease

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Drug Induced Liver Disease Study Group · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up.

Detailed description

This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM scale and/or expert evaluation, patients with a clinical diagnosis of acute DILI will be included in the study to establish a multi-center, prospective DILI cohort. Depending on the presence or absence of associated chronic liver disease, the patients will be divided into the basic DILI group with chronic liver disease and basic DILI group without chronic liver disease. All enrolled patients should complete at least six months of follow-up. This research will propose a new or optimized DILI diagnostic scheme based on the analysis of the problems existing in the practice of RUCAM scale, the clinical characteristics and prognosis of DILI, the exploration of biomarkers, and all the comprehensive information of big data from Hepatox platform, and establish a big data-based diagnosis model or auxiliary diagnosis decision system.

Conditions

• Acute Drug-induced Liver Injury
• Chronic Liver Disease

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-04-01
• Completion: 2021-10-01
• First posted: 2020-08-26
• Last updated: 2020-08-27