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
This trial does not accept healthy volunteersQualifiers
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 population
Adult with drug-induced liver injury
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 2 trial groupsGroup A: Modeling group
Group B: Validation group
Trial outcomes
Primary outcomes
1
death/liver transplantation
DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) . DILI is the primary indication for liver transplantation.
Time frame
1 year2
acute liver failure
Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompanied by mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.
Time frame
1 yearSecondary outcomes
1
chronic DILI
Chronicity is defined as the presence of any one of the following: (i) persistently elevated liver biochemistry indexes; (ii) radiological or histological evidence of persistent liver injury at one year after DILI onset.
Time frame
2 years2
recovery
Recovery status is defined as clinical and biochemical resolution within 1 year after DILI onset, with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤40 U/L, alkaline phosphatase (ALP) ≤150 U/L, and total bilirubin (TB) ≤1.5 upper limits of normal (ULN) (25.65 μmol/L).
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov