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A Prognostic Model for Drug-induced Liver Injury in China

Recruitingn/aAges 18 Years - anyAllBeijing Friendship Hospital
NCT05060289 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 .

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

13 sites
Beijing 302 Hospital
Beijing, China
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Beijing You 'an Hospital, Capital Medical University
Beijing, China
Beijing Ditan Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Qinzhou First People's Hospital
Guangxi, China
Hebei CNPC Central Hospital
Hebei, China

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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