RecruitingNot Applicable

A Prognostic Model for Drug-induced Liver Injury in China

China3,000 participantsStarted 2022-05-25

Plain-language 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 .

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

death/liver transplantation

Timeframe: 1 year

acute liver failure

Timeframe: 1 year

Trial details

NCT IDNCT05060289

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Yan Wang

18810530724 wangyanpku@163.com

View on ClinicalTrials.gov More Drug-induced Liver Injury trials