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

Drug-induced Liver Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02061826
• Other study ID #: Ditan-2014-01
• Status: Not yet recruiting
• Phase: N/A
• First received: January 26, 2014
• Last updated: February 15, 2014
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: February 2014
• Source: Beijing Ditan Hospital
• Contact: Wen Xie, master
• Phone: +86 84322816
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control

Related Conditions & MeSH terms

• Drug-induced Liver Injury

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histological features of drug-induced liver injury obtained by liver biopsy	Liver biopsy is the main method	within six months of the DILI onset date	No
Primary	clinical features of drug-induced liver injury assessed by serum parameters of liver function	serum parameters of liver function is the focus	participants will be followed for the duration of hospital stay, an expected average of 3 weeks	No