Clinical Trial: Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)
Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational [Patient Registry]
Official Title: Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA
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 Summary: 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.
Sponsor: Beijing Ditan Hospital
Current Primary Outcome:
- 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
Original Primary Outcome:
- histological features of DILI obtained by liver biopsy [ Time Frame: within six months of the DILI onset date ]
- clinical features of DILI 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 ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Beijing Ditan Hospital
Dates:
Date Received: January 26, 2014
Date Started: May 2014
Date Completion: April 2017
Last Updated: February 15, 2014
Last Verified: February 2014
