A Retrospective Study on Drug Induced Liver Injury in China

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 2016

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.

Clinical Trial Outcome Measures

Primary Measures

  • diagnosis of drug-induced liver injury
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Drug Induced Liver Disease Study Group
  • Collaborator
    • Unimed Scientific Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yimin Mao, MD, Study Chair, RenJi Hospital
    • Chengwei Chen, MD, Study Chair, No. 85 Hospital of PLA

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