A Prognostic Model for Drug-induced Liver Injury in China
Trial Parameters
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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 .
Eligibility Criteria
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. Sepsi