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

• Conditions: Drug-induced Liver Injury

• Registration Number: NCT02061826
• Lead Sponsor: Beijing Ditan Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2014-01-26
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-13
• Last Update Submitted: 2014-02-15
• Last Update Posted: 2014-02-19
• Study Start: 2014-05
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Ditan Hospital; 🇨🇳 Beijing, China