Status:
UNKNOWN
A Diagnostic Study on Patients With Drug-induced Liver Injury
Lead Sponsor:
Drug Induced Liver Disease Study Group
Conditions:
Acute Drug-induced Liver Injury
Chronic Liver Disease
Eligibility:
All Genders
Brief Summary
This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM sc...
Detailed Description
This study is a multi-center, prospective, non-interventional cohort study with an estimated enrollment of 600 patients with acute DILI. According to the inclusion and exclusion criteria, the RUCAM sc...
Eligibility Criteria
Inclusion
- No restriction on age and gender.
- Patients need to meet one of the following biochemical thresholds for acute liver injury recommended by the international consensus:
- ALT \< 5 x ULN
- ALP \< 2 x ULN
- ALT 3 ULN and TBIL 2 ULN
- The duration of liver biochemical abnormalities does not exceed 90 days.
- For the clinical diagnosis of acute drug-induced liver injury, the RUCAM scale ≥ 6 points is required. However, if the RUCAM scale score is 3-5 points, the opinions of 3 experts are needed to confirm the diagnosis of DILI, and the patients can only be enrolled after the experts agree to it.
- The patient signs the informed consent form after fully understanding the nature of the study, the nature of his/her disease, related treatment methods, and the potential risks associated with participating in the trial.
Exclusion
- Non-drug induced liver injury
- An inability to complete the visits prescribed by the study
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04526548
Start Date
October 1 2020
End Date
October 1 2021
Last Update
August 27 2020
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