Registry for patients with drug-induced liver injury
Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study
This study is creating a national registry to collect information and samples from people who have had liver injuries caused by medications, so researchers can learn more about how these injuries happen.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 6 sites (Los Angeles, California and 5 other locations) |
| Trial ID | NCT00360646 on ClinicalTrials.gov |
What this trial studies
This study aims to create a nationwide registry of patients who have experienced drug-induced liver injury (DILI) by collecting and storing biological specimens such as serum, DNA, and lymphocytes. The registry will serve as a resource for future research into the mechanisms behind severe idiosyncratic DILI. Patients who meet specific criteria will be included, and their clinical data will be documented to facilitate further investigations. The study will also maintain a database for potential future contact with participants.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have suffered from clinically significant drug-induced liver injury and have sufficient documentation of their condition.
Not a fit: Patients who have not experienced drug-induced liver injury or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of drug-induced liver injury and improve patient safety regarding drug prescriptions.
How similar studies have performed: Other studies have successfully established registries for similar conditions, indicating that this approach is viable and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Where this trial is running
Los Angeles, California and 5 other locations
- University of Southen California — Los Angeles, California, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- NIH Clinical Site — Bethesda, Maryland, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Univeristy of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Thomas Jefferson — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Huiman X. Barnhart, PhD — Duke University
- Study coordinator: Eilene Pham
- Email: eilene.pham@duke.edu
- Phone: 919-660-7253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.