Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)

Overview

The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.

Full Title of Study: “Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
  • Study Primary Completion Date: April 2017

Detailed Description

Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.

Clinical Trial Outcome Measures

Primary Measures

  • histological features of drug-induced liver injury obtained by liver biopsy
    • Time Frame: within six months of the DILI onset date
    • Liver biopsy is the main method
  • clinical features of drug-induced liver injury assessed by serum parameters of liver function
    • Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
    • serum parameters of liver function is the focus

Participating in This Clinical Trial

Inclusion Criteria

  • Males and females between the age of 18 to 70 years
  • Women in child-bearing period taking some contraception measures
  • Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method(RUCAM ) score≥6
  • Written informed consent can be obtained, some patients agree with liver biopsy

Exclusion Criteria

  • Viral hepatitis
  • Alcoholic liver disease or non-alcoholic liver disease
  • Wilson's disease or other inherited metabolic liver diseases
  • Auto-immune liver diseases
  • Any dysfunction of liver
  • Malnutrition
  • Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases
  • Patients who can not complete follow-ups on time

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Beijing Ditan Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wen Xie, head of department – Beijing Ditan Hospital
  • Overall Official(s)
    • Wen Xie, master, Study Director, Beijing Ditan Hospital
  • Overall Contact(s)
    • Wen Xie, master, +86 84322816

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