Dataset from Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study

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 caused by four specific drugs, 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.