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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

Tracking Information
First Submitted Date January 26, 2014
First Posted Date February 13, 2014
Last Update Posted Date February 19, 2014
Study Start Date May 2014
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2014)
  • 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 Measures
 (submitted: February 12, 2014)
  • 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 ]
Change History Complete list of historical versions of study NCT02061826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Establishment of Drug-induced Liver Injury Databases and Application of Circulating microRNA(miRNA)
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 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 [Patient Registry]
Study Design Observational Model: Case Control
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum,plasma,PBMC
Sampling Method Probability Sample
Study Population community sample and primary care clinic
Condition Drug-induced Liver Injury
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 12, 2014)
800
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02061826
Other Study ID Numbers Ditan-2014-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wen Xie, Beijing Ditan Hospital
Study Sponsor Beijing Ditan Hospital
Collaborators Not Provided
Investigators
Study Director: Wen Xie, master Beijing Ditan Hospital
PRS Account Beijing Ditan Hospital
Verification Date February 2014