Actively Recruiting
A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China
Led by Drug Induced Liver Disease Study Group · Updated on 2025-05-04
10000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand patients with drug-induced liver injury (DILI) in various hospitals across mainland China, including Western medicine, Chinese medicine, integrated hospitals, and specialist hospitals for conditions like tuberculosis. The study focuses on evaluating the clinical characteristics, progression, and influencing factors of DILI in real-world clinical practice. It also seeks to learn about suspected drugs causing DILI, rechallenging, and patterns of liver biochemical abnormalities. The study is a multi-center, prospective, non-interventional cohort study that observes patients without providing experimental treatment. It involves different cohorts receiving standard care or treatments such as compound glycyrrhizin tablets/injection, isoglycyrrhizinate magnesium injection, diammonium glycyrrhizinate capsules, bicyclol, silibinin capsules, ursodeoxycholic acid capsules, and N-acetylcysteine. The study will assess compliance with DILI guidelines, histological features, and specific populations including elderly and children with liver disease backgrounds. Participants will be monitored over time to observe disease progression including outcomes like death, liver failure, chronic DILI, or recovery within six months. Researchers will collect clinical data, liver function tests, and other relevant information to evaluate the course of DILI and factors affecting outcomes. The study will continue until December 2030, focusing on real-world data without altering patient treatment plans.
CONDITIONS
Brief Title
A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of drug-induced liver injury according to the 2015 Chinese DILI treatment guidelines
- RUCAM score of 6 or higher, or between 3 and 5 confirmed by three experts
- Ability to provide informed consent
You will not qualify if you...
- Liver injury not caused by drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants are observed to assess clinical outcomes and influencing factors of drug-induced liver injury in a real-world setting.
Regular visits depending on clinical needs
Trial Site Locations
Total: 1 location
1
Renji hospital
Shanghai, China
Actively Recruiting
Research Team
C
Chunxia Zhang
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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