A Prognostic Model for Drug-induced Liver Injury in China
ConditionDrug-induced Liver Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsSponsors and collaborators
Source ClinicalTrials.gov