The Drug-Induced Liver Injury Network (DILIN)
DILIN consists of a Data Coordinating Center at the Duke Clinical Research Institute and the following clinical sites: Paul B. Watkins, MD University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7600 Phone: (919) 966-0128 E-mail: suspusek@med.unc.edu Herbert L. Bonkovsky, MD University of Connecticut Health Center Farmington, CT 06030-1111 Phone: (860) 679-4725 E-mail: laska@nso.uchc.edu Robert J. Fontana, MD University of Michigan Ann Arbor, MI 48109-0362 Phone: (866) 865-4837 E-mail: tayehn@umich.edu Naga P. Chalasani, MD Indiana University Indianapolis, IN 46202-5111 Phone: (317) 287-3062 E-mail: acorne@iupui.edu
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Timothy J. Davern, MD University of California at San Francisco San Francisco, CA 94143 Phone: (415) 502-3105 E-mail: moawadd@itsa.ucsf.edu
WEBSITE:
Idiosyncratic Liver Injury Associated with Drugs (ILIAD)
A STUDY OF DRUG-INDUCED LIVER INJURY DUE TO PHENYTOIN, ISONIAZID, AMOXICILLIN/CLAVULANIC ACID, AND VALPROIC ACID
http://dilin.dcri.duke.edu
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FUNDED BY THE NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
DRUG-INDUCED LIVER INJURY NET WORK
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
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The ILIAD Study
BACKGROUND: ILIAD’S RESEARCH GOALS: ELIGIBILITY CRITERIA:
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 has 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 NIDDK has established the Drug-Induced Liver Injury Network to conduct controlled, clinical studies into DILI.
● Establish a database of patients with severe DILI due to 4 specific drugs ● 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:
● Alive, with DILI onset on or after January 1, 1994 ● Age > 2 years old at enrollment ● The implicated medication is isoniazid (INH), phenytoin (Dilantin), combination clavulanic acid/amoxicillin (Augmentin), or valproic acid (Depakote) ● 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:
We need your help with patient recruitment. If you have patients who are eligible, we want to hear from you.
● 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.
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