Actively Recruiting
DILIN - Prospective Study
Led by Duke University · Updated on 2026-04-08
4000
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 identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.
CONDITIONS
Official Title
DILIN - Prospective Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 2 years at enrollment into the study.
- Evidence of liver injury suspected to be related to drug or CAM use within 6 months before enrollment.
- Written informed consent from the patient or legal guardian.
- Documented clinically important DILI, defined by at least one of the following:
- ALT or AST >5 times the upper limit of normal (ULN) or alkaline phosphatase >2 times ULN on at least 2 consecutive blood tests if previous values were normal.
- If baseline liver enzymes are elevated, then ALT or AST >5 times baseline or alkaline phosphatase >2 times baseline on at least 2 consecutive blood tests.
- Any elevation of ALT, alkaline phosphatase, or AST with increased total bilirubin ≥ 2.5 mg/dL without prior liver disease or coagulopathy with INR > 1.5 without coumadin therapy or vitamin K deficiency.
You will not qualify if you...
- Competing cause of acute liver injury such as hepatic ischemia judged to be the primary reason.
- Known pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease.
- Acetaminophen hepatotoxicity.
- Liver or bone marrow transplant before development of 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 Southern 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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