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

Recruiting

• Conditions: Drug-induced Liver Injury

• Registration Number: NCT02961413
• Lead Sponsor: Drug Induced Liver Disease Study Group

Brief 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.)

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-10-24
• Study First Submitted QC: 2016-11-10
• Study First Posted: 2016-11-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease progression of DILI (drug-induced liver injury ), i.e. death, liver failure, chronic DILI, recover	6 months

Trial Locations

Locations (1)

Renji hospital; 🇨🇳 Shanghai, China