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Clinical trialNCT00360646RecruitingObservational

Drug-Induced Liver Injury (DILI) Network Retrospective

SponsorDuke UniversityEnrollment400Drug Induced Liver Injury
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

6 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Southen California

    Los Angeles, California, United States

    Andrew Stolz, MD
    Recruiting
  • Indiana University

    Indianapolis, Indiana, United States

    Naga P Chalasani, MD
    Recruiting
  • Nih Clinical Site

    Bethesda, Maryland, United States

    Recruiting
  • University of Michigan

    Ann Arbor, Michigan, United States

    Robert J Fontana, MD
    Recruiting
  • Univeristy of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, United States

    Paul B Watkins, MD
    Recruiting
  • Thomas Jefferson

    Philadelphia, Pennsylvania, United States

    Dima Halegoua-DeMarzio, MD
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2004
Primary completion
31 Jul 2028
Completion
31 Jul 2028
Last update posted
8 Apr 2026
Registered enrollment
400
Registry id
NCT00360646

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.