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

Drug Induced Liver Disease Study Group

Status: Enrolling

Conditions: Drug-induced Liver Injury

Study type: Observational

Funder types: Other

Identifiers

NCT02961413

2012ZX09303-002

Details and patient eligibility

About

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.

Full 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.)

Enrollment: 10,000 estimated patients

Sex: All

Volunteers: No 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

Trial design

10,000 participants in 6 patient groups

cohort 1

Description:

Compound glycyrrhizin tablets / injection

cohort 2

Description:

Isoglycyrrhizinate magnesium injection / diammonium glycyrrhizinate enteric-coated capsules

cohort 3

Description:

Bicyclol

cohort 4

Description:

Silibinin capsules

cohort 5

Description:

Ursodeoxycholic acid capsules

cohort 6

Description:

N- acetylcysteine