Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury.
James Rochon, Petr Protiva, Leonard B Seeff...
https://pubmed.ncbi.nlm.nih.gov/18798340Actively Recruiting
Age: 2Years +
All Genders
ID00360646
Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study
Led by Duke University · Updated on 2026-04-08
400
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to create a nationwide registry of patients who have experienced severe drug-induced liver injury (DILI) to help understand this condition better. The study focuses on collecting and storing biological samples like serum, DNA, and lymphocytes from these patients. The goal is to build a clinical database and specimen bank to support future research into why some people develop severe DILI. This effort is part of the Drug-Induced Liver Injury Network (DILIN) established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The study retrospectively identifies individuals who had severe DILI episodes due to drugs or herbal and dietary supplements (HDS/CAM) starting from January 1, 1994. Researchers collect clinical information and biological specimens, including immortalized lymphocytes that provide ongoing access to DNA and living immune cells for analysis. The study maintains a registry with yearly updates to allow recontacting participants for future research. Participants provide medical information and blood samples for genetic and other analyses. Researchers track and update contact details annually to facilitate future studies. The primary outcome is to maintain this registry through July 2028. The study involves no investigational treatments but focuses on gathering data and samples for ongoing and future mechanistic investigations into severe DILI.
CONDITIONS
Brief Title
Drug-Induced Liver Injury (DILI) Network Retrospective
Who Can Participate
Age: 2Years +
All Genders
Eligibility Criteria
You may qualify if you...
- The treating healthcare professional must believe the subject suffered drug-induced liver injury
- The subject must be alive with liver injury onset on or after January 1, 1994
- Evidence of liver injury related to a drug or herbal/dietary supplement
- The subject is taking only one drug or herbal/dietary supplement before the liver injury onset
- Clinically important liver injury shown by liver enzyme tests (AST, ALT, alkaline phosphatase)
- Sufficient documentation for causality assessment
You will not qualify if you...
- Not willing to provide medical information and blood samples
- Unable to give informed consent, including for genetic testing
- Age under 2 years at study enrollment
- Presence of other liver diseases like autoimmune hepatitis, primary biliary cirrhosis, or chronic biliary tract disease
- Liver injury caused primarily by other conditions such as hepatic ischemia
- History of acetaminophen toxicity, liver transplant, or bone marrow transplant before drug-induced liver injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) to confirm eligibility and collect initial information
Diagnostic Evaluation
Duration - One-time data and sample collection
Participants provide medical information and biological specimens to help establish and maintain a clinical database and specimen bank related to drug-induced liver injury.
1 visit (in-person) for medical record review and sample collection
Long-term Monitoring
Duration - Up to several years with yearly updates
Participants are registered and their contact information is updated yearly to allow for future recontact and follow-up studies.
Annual contact updates (remote or in-person) to maintain registry information
Trial Site Locations
Total: 6 locations
1
University of Southen California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Indiana University
Indianapolis, Indiana, United States, 46202-5111
Actively Recruiting
3
NIH Clinical Site
Bethesda, Maryland, United States, 20892
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48109-0362
Actively Recruiting
5
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7600
Actively Recruiting
6
Thomas Jefferson
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
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Research Team
E
Eilene Pham
M
Matt Baum
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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