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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02961413

Acronym

DILI-P

Enrollment

10000

Registered

2016-11-11

Start date

2016-04-30

Completion date

2030-12-31

Last updated

2025-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-induced Liver Injury

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.)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactChunxia Zhang

chunxia.zhang@unimedsci.com

Outcome results