NCT00360646 Drug-Induced Liver Injury (DILI) Network Retrospective
| NCT ID | NCT00360646 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Drug Induced Liver Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2004-09 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2004-09 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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 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 Criteria: 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.
Contact & Investigator
Huiman X. Barnhart, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT00360646 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Drug Induced Liver Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00360646 currently recruiting?
Yes, NCT00360646 is actively recruiting participants. Contact the research team at eilene.pham@duke.edu for enrollment information.
Where is the NCT00360646 trial being conducted?
This trial is being conducted at Los Angeles, United States, Indianapolis, United States, Bethesda, United States, Ann Arbor, United States and 2 additional locations.
Who is sponsoring the NCT00360646 clinical trial?
NCT00360646 is sponsored by Duke University. The principal investigator is Huiman X. Barnhart, PhD at Duke University. The trial plans to enroll 400 participants.