To establish a nationwide registry of people who have experience past liver injury due to prescription drugs and alternative agents like herbal and dietary supplements (HDS). This is an ongoing registry that has been active since 1994. Since this is a retrospective registry, it is possible participation can be done remotely and not necessarily on-site. Please contact one of the DILIN sites for more information on participation..
Background
Drug-induced liver injury (DILI) is the most common reason for regulatory actions concerning drugs in development and in clinical practice. Fortunately, severe DILI leading to jaundice is an infrequent event, with an annual incidence ranging from 1 in 10,000 to 1 in 1,000,000 prescription-years. The idiosyncratic nature of DILI plus its low incidence have hampered our ability to identify clinical, environmental, and genetic susceptibility factors. As a result, there is a great need to improve our detection, definition, and understanding of the mechanism of DILI.
To stimulate research, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has established the Drug-Induced Liver Injury Network (DILIN) to conduct controlled, clinical studies into DILI.
ILIAD’s Research Goals
- Establish a database of patients with severe DILI due to use of drugs or Herbal and Dietary Supplements known as HDS.
- Establish a bank of biological specimens (serum, DNA, and immortalized lymphocytes) from DILI cases and controls.
- Maintain a registry of DILI cases with annual contact.
How You Can Help
We need your help with patient recruitment. If you have patients who are eligible, contact the DILIN clinical site closest to you.
Eligibility Criteria
- Alive, with DILI onset on or after January 1, 1994.
- Age > 2 years old at enrollment.
- The implicated medications are drugs or Herbal and Dietary Supplements known as HDS.
- Peak total serum bilirubin > 2.5 mg/dl or, if valproic acid, INR > 1.5 / hospitalized.
- Detailed documentation of the event for causality assessment.
Study Protocol
- Screening criteria are reviewed during the initial contact with the subject.
- Clinical data are collected using a telephone or personal-interview format.
- Detailed data are abstracted from medical records and charts.
- A blood sample is drawn and forwarded to a repository.