Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT00360646

Conditions

Drug Induced Liver Injury

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Drug Induced Liver Injury

Study ID

NCT00360646

Start date

Sep, 2004

Status verified date

Apr, 2026

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects with liver injury

Subjects without liver injury

Primary outcome measure

  • maintain a registry of cases in the ILIAD database [ Time Frame: July 2028 ]

Central Contacts and Locations

Central contacts

Eilene Pham

919-660-7253eilene.pham@duke.edu

Matt Baum

919-668-0486matt.baum@duke.edu

Locations

University of Southen California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Susan Milstein, RN

323-442-2699smilstei@usc.edu

Neil Kaplowitz, MD

323-442-5576kaplowit@usc.edu

Principal Investigator:

Andrew Stolz, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202-5111

Contacts

Jennifer Terrell

317-278-6266jkramey@iu.edu

Principal Investigator:

Naga P Chalasani, MD

NIH Clinical Site

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Jaha Norman-Wheeler

301-435-6122jaha.norman-wheeler@nih.gov

Chris Koh, MD

christopher.koh@nih.gov

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109-0362

Contacts

Josefa Kaganove

kaganovj@med.umich.edu

Principal Investigator:

Robert J Fontana, MD

Univeristy of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-7600

Contacts

Jacquee Simpson

Jacqueline_Simpson@med.unc.edu

Principal Investigator:

Paul B Watkins, MD

Thomas Jefferson

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Katrin Koy

215-456-2004koykatri@einstein.edu

Principal Investigator:

Dima Halegoua-DeMarzio, MD

More Information

Sponsor

Duke University

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • LIVER DIS
  • CHEM IND
  • Drugs
  • Drug induced liver injury
  • phenotype
  • cholestatic liver injury
  • hepatocellular liver injury
  • mixed liver injury
  • genotype

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-08.