A Retrospective Study on Drug Induced Liver Injury in China (DILI-R)

Drug Induced Liver Disease Study Group

Status: Completed

Conditions: Drug-Induced Liver Injury

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02407964

2012ZX09303-001

Details and patient eligibility

About

This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

Full description

This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

It investigates medical records of patients who were hospitalized during 2012 to 2014. Those patients should be diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.

Enrollment: 15,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any hospitalized patients who were diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
• The drug-induced liver injury and similar diagnosis were not excluded the possibility of drug-induced nature.

Exclusion criteria

• Confirmed non-drug induced liver injury.
• Insufficient clinical data supporting the diagnosis of drug-induced liver injury.
• Liver injury resulted from poisons and chemicals.