Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)
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ClinicalTrials.gov Identifier: NCT02061826
Recruitment Status : Unknown
Verified February 2014 by Wen Xie, Beijing Ditan Hospital. Recruitment status was: Not yet recruiting
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.
Condition or disease
Drug-induced Liver Injury
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.
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 ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
community sample and primary care clinic
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
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
Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases