A Prognostic Model for Drug-induced Liver Injury in China
A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study
Beijing Friendship Hospital
3,000 participants
May 25, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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.
Exclusion Criteria11
- 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.
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Locations(13)
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NCT05060289