A Prognostic Model for Drug-induced Liver Injury in China
- Conditions
- Drug-induced Liver Injury
- Registration Number
- NCT05060289
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
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 .
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3000
- 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.
- 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.
- Onset to enrollment ≤3 months.
- Hepatotropic viral infection: hepatitis A, B, C, D and E.
- Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
- Hypoxic ischemic hepatitis and congestive liver disease.
- Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
- Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
- Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
- Parasitic infection.
- Sepsis.
- Previous liver transplantation or bone marrow transplantation.
- Pregnancy or lactation.
- Genetic and metabolic liver diseases.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method acute liver failure 1 year 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.
death/liver transplantation 1 year 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.
- Secondary Outcome Measures
Name Time Method chronic DILI 2 years 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.
recovery 2 years 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).
Trial Locations
- Locations (13)
Jiaozuo People's Hospital
🇨🇳Jiaozuo, China
The Second Hospital of Lanzhou University
🇨🇳Lanzhou, China
Yuncheng Central Hospital
🇨🇳Yuncheng, China
Beijing You 'an Hospital, Capital Medical University
🇨🇳Beijing, China
Qinzhou First People's Hospital
🇨🇳Guangxi, China
Beijing 302 Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Qinghai People's Hospital
🇨🇳Qinghai, China
Hebei CNPC Central Hospital
🇨🇳Hebei, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Ditan Hospital
🇨🇳Beijing, China
Peking University Third Hospital
🇨🇳Beijing, China