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Status unknownNCT02061826Updated Feb 19, 2014

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

An observational study in Drug-induced Liver Injury, sponsored by Beijing Ditan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-19.

Sponsored by Beijing Ditan Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Enrollment
800
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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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Conditions studied

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In context

Chemical and Drug Induced Liver Injury

75 studies on the registry are indexed under Chemical and Drug Induced Liver Injury; 20 are open to participants now.

This study's planned enrollment of 800 is above the median of 504 across 38 observational studies indexed under Chemical and Drug Induced Liver Injury.

Browse Chemical and Drug Induced Liver Injury studies →

Lead sponsor

Beijing Ditan Hospital is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

community sample and primary care clinic

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

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
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Study design

Observational model
Case-control
Enrollment
800 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. histological features of drug-induced liver injury obtained by liver biopsy

    Liver biopsy is the main method

    Time frame: within six months of the DILI onset date

  2. clinical features of drug-induced liver injury assessed by serum parameters of liver function

    serum parameters of liver function is the focus

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks

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Study locations

1 site
  • Beijing Ditan Hospital
    Beijing, 100015, China
    • Hong Zhao, master · Contact · +86 84322816
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02061826
Lead sponsor
Beijing Ditan Hospital
Responsible party
Wen Xie (head of department, Beijing Ditan Hospital) — Principal investigator
First posted
Feb 13, 2014
Start date
May 2014
Primary completion
Apr 2017 (estimated)
Completion
Apr 2017 (estimated)
Last update
Feb 19, 2014

Study contacts

Wen Xie, master
Contact
+86 84322816
Wen Xie, master
study director · Beijing Ditan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.

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