NCT02961413

A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）

A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Drug Induced Liver Disease Study Group · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, non-interventional cohort study . Its primary objectives are: 1. assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice; 2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.

Detailed description

The main purpose of this study is to understand patients with DILI clinical outcome and influencing factors in China's second and tertiary general hospitals (including Western medicine hospital, Chinese medicine hospital andIntegrated traditional Chinese and Western Medicine Hospital) and vulnerabilities of drug-induced liver injury specialist hospital (tuberculosis hospital, Pulmonary, etc.) in mainland. The main purpose 1. assess the DILI patients' clinical outcomes and influencing factors in the real world; 2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc. Secondary objectives 1. assess the compliance of the DILI practice to the 2015 vision of the DILI guidelines in china.; 2. evaluate the histological features of DILI patients; 3. assessment DILI characteristics, prognosis and influencing factors in specific populations(such as the elderly, children with underlying liver disease background, etc.)

Conditions

• Drug-induced Liver Injury

Timeline

• Start date: 2016-04-01
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2016-11-11
• Last updated: 2025-05-04

Locations

1 site across 1 country: China