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

Drug-induced Liver Injury Clinical Trial

— DILI-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02961413
• Other study ID #: 2012ZX09303-002
• Status: Recruiting
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2020
• Source: Drug Induced Liver Disease Study Group
• Contact: Chunxia Zhang
• Email: chunxia.zhang[@]unimedsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug-induced Liver Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Renji hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Drug Induced Liver Disease Study Group

Country where clinical trial is conducted

China, 

Outcome

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