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

February 15, 2014 updated by: Wen Xie, Beijing Ditan Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wen Xie, master
  • Phone Number: +86 84322816

Study Locations

  • China
      • Beijing, China, 100015
        • Beijing Ditan Hospital
        • Contact:
          • Hong Zhao, master
          • Phone Number: +86 84322816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

community sample and primary care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within six months of the DILI onset date
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
participants will be followed for the duration of hospital stay, an expected average of 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Ditan Hospital

Investigators

  • Study Director: Wen Xie, master, Beijing Ditan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

January 26, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 15, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ditan-2014-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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