A Prognostic Model for Drug-induced Liver Injury in China

Beijing Friendship Hospital3,000 enrolled

Overview

A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers. A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .

Research Objectives: 1. To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data. 2. To establish and verify prognostic model(s) of DILI in China. 3. To explore novel serum biomarkers for the prognosis of DILI.

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Drug-induced Liver Injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN. 2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis. 3. Onset to enrollment ≤3 months. Exclusion Criteria: 1. Hepatotropic viral infection: hepatitis A, B, C, D and E. 2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc. 3. Hypoxic ischemic hepatitis and congestive liver disease. 4. Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years. 5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis. 6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment. 7. Parasitic infection. 8. Sepsis. 9. Previous liver transplantation or bone marrow transplantation. 10. Pregnancy or lactation. 11. Genetic and metabolic liver diseases.

Locations (13)

Beijing 302 Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

death/liver transplantation

DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) . DILI is the primary indication for liver transplantation.

Time frame: 1 year

acute liver failure

Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompanied by mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.

Time frame: 1 year

Secondary Outcomes

chronic DILI

Chronicity is defined as the presence of any one of the following: (i) persistently elevated liver biochemistry indexes; (ii) radiological or histological evidence of persistent liver injury at one year after DILI onset.

Time frame: 2 years

recovery

Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤40 U/L, alkaline phosphatase (ALP) ≤150 U/L, and total bilirubin (TB) ≤1.5 upper limits of normal (ULN) (25.65 μmol/L).

Time frame: 2 years

Central Contacts

Yan Wang

CONTACT

18810530724 wangyanpku@163.com

Zikun Ma

CONTACT

18311270304 maazikun0114@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.