Actively Recruiting
Drug-Induced Liver Injury (DILI) Network Retrospective
Led by Duke University · Updated on 2026-04-08
400
Participants Needed
6
Research Sites
1247 weeks
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
The purpose of this study is to establish retrospectively a nationwide registry of patients who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of individuals who have experienced severe DILI and the relevant clinical data concerning the episode of DILI; and, (b) to create a bank of biological specimens obtained from these individuals. These biological specimens will be DNA, plasma, and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of genomic DNA for study as well as living immune cells for phenotyping studies. A secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that they may be recontacted in the future. It is expected that this will facilitate additional studies exploring the mechanisms of DILI.
CONDITIONS
Official Title
Drug-Induced Liver Injury (DILI) Network Retrospective
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The treating gastroenterologist, hepatologist, or healthcare professional must believe the subject suffered drug-induced liver injury
- The subject must be alive and have had the qualifying DILI episode on or after January 1, 1994
- Evidence of liver injury related to consumption of a drug or herbal/dietary supplement (HDS/CAM)
- The subject was taking only one drug or HDS agent leading up to the DILI episode
- Clinically important DILI shown by elevated serum AST, ALT, and alkaline phosphatase levels
- Sufficient documentation of the event for causality determination
You will not qualify if you...
- Not willing to provide medical information and blood samples
- Unable to give informed consent for participation and blood draw
- Under 2 years old at study enrollment
- Have another primary cause of liver injury such as hepatic ischemia
- Known pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease
- Acetaminophen hepatotoxicity
- History of liver transplant or allogeneic bone marrow transplant before developing drug or CAM-induced liver injury
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
E
Eilene Pham
CONTACT
M
Matt Baum
CONTACT
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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