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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
First Posted : February 13, 2014
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Wen Xie, 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.

Condition or disease
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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case Control
Target Follow-Up Duration: 3 Years
Official Title: Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA
Study Start Date : May 2014
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017



Primary Outcome Measures :
  1. 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

  2. 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


Biospecimen Retention:   Samples With DNA
whole blood, serum,plasma,PBMC


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
community sample and primary care clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061826


Contacts
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Contact: Wen Xie, master +86 84322816

Locations
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China
Beijing Ditan Hospital Not yet recruiting
Beijing, China, 100015
Contact: Hong Zhao, master    +86 84322816      
Sponsors and Collaborators
Beijing Ditan Hospital
Investigators
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Study Director: Wen Xie, master Beijing Ditan Hospital

Additional Information:

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Responsible Party: Wen Xie, head of department, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02061826     History of Changes
Other Study ID Numbers: Ditan-2014-01
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
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Wounds and Injuries
Chemical and Drug Induced Liver Injury
Liver Diseases
Digestive System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning