A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Drug-induced Liver Injury
- Sponsor
- Drug Induced Liver Disease Study Group
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover
- Status
- Recruiting
- Last Updated
- 12 months ago
Overview
Brief Summary
This is a multi-center, prospective, non-interventional cohort study .
Its primary objectives are:
- assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice;
- 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.)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of DILI patients with various types and severity according to the 2015 version of the Chinese DILI treatment guidelines
- •RUCAM ≥6, or RUCAM between 3-5 is required by the three experts determined that the drug-induced liver injury
- •patient can provide informed consent form
Exclusion Criteria
- •non-drug-induced liver injury
Outcomes
Primary Outcomes
Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover
Time Frame: 6 months