A Retrospective Epidemiologic Study on Incidence and Treatment Status of Hospitalized Drug Induced Liver Injury Patients in Mainland China

Drug Induced Liver Disease Study Group370 sites in 1 country15,000 target enrollmentMarch 2015

Overview

Brief Summary

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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

July 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Drug Induced Liver Disease Study Group

Responsible Party

Sponsor

Eligibility Criteria

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.