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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02061826

Enrollment

800

Registered

2014-02-13

Start date

2014-05-31

Completion date

2017-04-30

Last updated

2014-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug-induced Liver Injury

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
histological features of drug-induced liver injury obtained by liver biopsy	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	participants will be followed for the duration of hospital stay, an expected average of 3 weeks	serum parameters of liver function is the focus

Countries

China

Contacts

Primary ContactWen Xie, master

+86 84322816

Outcome results