Status:
RECRUITING
Drug-Induced Liver Injury (DILI) Network Retrospective
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Drug Induced Liver Injury
Eligibility:
All Genders
2+ years
Brief 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 l...
Detailed 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 restrict...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00360646
Start Date
September 1 2004
End Date
July 31 2028
Last Update
April 20 2025
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southen California
Los Angeles, California, United States, 90033
2
Indiana University
Indianapolis, Indiana, United States, 46202-5111
3
NIH Clinical Site
Bethesda, Maryland, United States, 20892
4
University of Michigan
Ann Arbor, Michigan, United States, 48109-0362