Drug-Induced Liver Injury (DILI) Network Retrospective
ILIAD
Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study
4 other identifiers
observational
400
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2004
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
April 8, 2026
April 1, 2026
23.9 years
August 2, 2006
April 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
maintain a registry of cases in the ILIAD database
maintain a registry of cases in the ILIAD database
July 2028
Study Arms (2)
Subjects with liver injury
Subjects without liver injury
Eligibility Criteria
Patients with liver injury ascribed to any drug or HDS/CAM agent which the DILI onset date occurred beyond six months from enrollment.
You may qualify if:
- Screening Criteria
- To be included in the ILIAD registry, the following criteria must be satisfied:
- The treating gastroenterologist / hepatologist or health care professional must believe that the subject suffered drug-induced liver injury;
- The subject must be alive and the date of onset of the qualifying DILI episode must have occurred on or after January 1, 1994;
- Evidence of injury that is known or suspected to be related to consumption of a drug or HDS/CAM product
- The subject is taking only one of these drugs or HDS agent(s) in the period leading up to the onset of the qualifying DILI episode;
- Have clinically important DILI defined in terms of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (Alk Phos).
- Sufficient documentation of the event for the Causality Committee to make a determination.
You may not qualify if:
- Subjects will be excluded according to the following criteria:
- are not willing to have medical information and blood samples taken;
- are unable to adequately give informed consent to participate in the study including the blood draw for the genetic component;
- age \< 2 years old at the time of study enrollment (due to blood volume requirements).
- Have a competing cause of liver injury such as hepatic ischemia that the investigator felt to be the primary reason for the observed liver injury. Known, pre-existing autoimmune hepatitis; primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease. Subjects are excluded due to acetaminophen hepatoxicity or liver transplant or allogeneic bone marrow transplant prior to development of drug-CAM induced liver injury.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Southen California
Los Angeles, California, 90033, United States
Indiana University
Indianapolis, Indiana, 46202-5111, United States
NIH Clinical Site
Bethesda, Maryland, 20892, United States
University of Michigan
Ann Arbor, Michigan, 48109-0362, United States
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600, United States
Thomas Jefferson
Philadelphia, Pennsylvania, 19141, United States
Related Publications (1)
Rochon J, Protiva P, Seeff LB, Fontana RJ, Liangpunsakul S, Watkins PB, Davern T, McHutchison JG; Drug-Induced Liver Injury Network (DILIN). Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Hepatology. 2008 Oct;48(4):1175-83. doi: 10.1002/hep.22442.
PMID: 18798340BACKGROUND
Related Links
Biospecimen
Samples with DNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huiman X. Barnhart, PhD
Duke University
- STUDY CHAIR
Robert Fontana, MD
University of Michigan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 4, 2006
Study Start
September 1, 2004
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
April 8, 2026
Record last verified: 2026-04