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 groupsLocations
13Beijing 302 Hospital100166, BeijingBeijing Municipality, China
Beijing Ditan Hospital100102, Beijing China
Beijing Friendship Hospital, Capital Medical University100050, Beijing China
Beijing You 'an Hospital, Capital Medical University100069, Beijing China
Sponsors and collaborators
Beijing Friendship Hospital
Lead sponsor
Source ClinicalTrials.gov