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

Capital Medical University

Status: Unknown

Conditions: Drug-induced Liver Injury

Study type: Observational

Funder types: Other

Identifiers

NCT02061826

Ditan-2014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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