Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study
Duke University
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.
Description
Drug-induced liver injury (DILI) is the single most common reason for regulatory actions concerning drugs, including failure to gain approval for marketing, removal from the market place, and restriction of prescribing indications. DILI is also a significant cause of morbidity and mortality in many patient populations. To stimulate and facilitate research into DILI, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has recently established the Drug-Induced Liver Injury Network (DILIN). One of the initial projects to be conducted by the network is to retrospectively e…
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- No
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 onse…
Locations (6)
- University of Southen CaliforniaLos Angeles, California
- Indiana UniversityIndianapolis, Indiana
- NIH Clinical SiteBethesda, Maryland
- University of MichiganAnn Arbor, Michigan
- Univeristy of North Carolina at Chapel HillChapel Hill, North Carolina
- Thomas JeffersonPhiladelphia, Pennsylvania