NCT02407964

A Retrospective Study on Drug Induced Liver Injury in China

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15,000 (actual)
• Sponsor: Drug Induced Liver Disease Study Group · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Drug-Induced Liver Injury

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-05-01
• Completion: 2016-07-01
• First posted: 2015-04-03
• Last updated: 2016-10-26

Locations

371 sites across 1 country: China