AzTrials
AzTrials

Drug Induced Liver InjuryILIADNCT00360646

Drug-Induced Liver Injury (DILI) Network Retrospective

An observational study of Drug Induced Liver Injury, run by Duke University at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Drug Induced Liver Injury
How many people
400 participants
Where
6 sitesUnited States
Study dates
Sep 2004to 31 Jul 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with liver injury ascribed to any drug or HDS/CAM agent which the DILI onset date occurred beyond six months from enrollment.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eilene Pham contact

919-660-7253

eilene.pham@duke.edu

Matt Baum contact

919-668-0486

matt.baum@duke.edu

6 sites in 1 country

United States6 sites, 6 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109-0362

    Josefa Kaganove, kaganovj@med.umich.edu

    Robert J Fontana, MD

    Recruiting

  • NIH Clinical Site

    Bethesda, Maryland, 20892

    Jaha Norman-Wheeler, 301-435-6122, jaha.norman-wheeler@nih.gov

    Chris Koh, MD, christopher.koh@nih.gov

    Recruiting

  • Univeristy of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7600

    Jacquee Simpson, Jacqueline_Simpson@med.unc.edu

    Paul B Watkins, MD

    Recruiting

  • Indiana University

    Indianapolis, Indiana, 46202-5111

    Jennifer Terrell, 317-278-6266, jkramey@iu.edu

    Naga P Chalasani, MD

    Recruiting

  • University of Southen California

    Los Angeles, California, 90033

    Susan Milstein, RN, 323-442-2699, smilstei@usc.edu

    Neil Kaplowitz, MD, 323-442-5576, kaplowit@usc.edu

    Recruiting

  • Thomas Jefferson

    Philadelphia, Pennsylvania, 19141

    Katrin Koy, 215-456-2004, koykatri@einstein.edu

    Dima Halegoua-DeMarzio, MD

    Recruiting

Other trials in United States

About this study

Official title: Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study

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.

Read the 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 restriction of prescribing indications. DILI is also a significant cause of morbidity and mortality in many patient populations. To stimulate and facilitate research into DILI, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has recently established the Drug-Induced Liver Injury Network (DILIN). One of the initial projects to be conducted by the network is to retrospectively establish a nationwide registry of patients who have suffered severe idiosyncratic liver injury associated with any drugs (ILIAD) and HDS agents, and to collect, immortalize and store serum, DNA, and lymphocytes from these patients (hereafter referred to as the "ILIAD protocol"). This ILIAD protocol will serve as a resource for subsequent mechanistic investigations of the basis for susceptibility to severe idiosyncratic DILI.

The network will initially identify people who have developed DILI onset beyond 6 months of enrollment due to all drugs or HDS/CAM cases that did not meet the entrance criteria for the Prospective study.

The specific aims are as follows:

  1. Establish and maintain a clinical database of these people that contains relevant clinical data.
  2. Establish a bank of biological specimens (serum, DNA, and immortalized lymphocytes) prepared from cases and control in the clinical database.
  3. Maintain a registry including yearly updated contact information of the subjects enrolled in the clinical database so that it is possible to recontact these individuals at a later date to offer participation in studies which are not part of the current proposal.
Keywords
LIVER DIS, CHEM IND, Drugs, Drug induced liver injury, phenotype, cholestatic liver injury, hepatocellular liver injury, mixed liver injury, genotype
Medical subject headings
Chemical and Drug Induced Liver Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00360646
Study groupRoleWhat they receive
Subjects with liver injuryNot described
Subjects without liver injuryNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maintain a registry of cases in the ILIAD database

    maintain a registry of cases in the ILIAD database

    Measured: July 2028

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2006 (estimated)
  2. Study startSep 2004
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00360646
Sponsor's protocol ID
Pro00113362
Other IDs
2U01DK065176-21, Pro00072297, Pro00017208
Acronym
ILIAD
Status last verified
Apr 2026
First submitted
2 Aug 2006
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Rochon J, Protiva P, Seeff LB, Fontana RJ, Liangpunsakul S, Watkins PB, Davern T, McHutchison JG; Drug-Induced Liver Injury Network (DILIN). Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Hepatology. 2008 Oct;48(4):1175-83. doi: 10.1002/hep.22442.

    PubMed 18798340

  • Zaborenko CJ, Schwantes-An TH, Li YJ, Dellinger A, Nicoletti P, Daly AK, Aithal G, Chalasani N; Drug-Induced Liver Injury Network. HLA and non-HLA genetic analyses reveal suggestive variants associated with statin-induced liver injury. Hepatol Commun. 2026 Aug 28;10(9):e1026. doi: 10.1097/HC9.0000000000001026. eCollection 2026 Sep 1.

    PubMed 42684112

Questions about this trial

What is this clinical trial studying?

An observational study of Drug Induced Liver Injury, run by Duke University at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eilene Pham (919-660-7253, eilene.pham@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maintain a registry of cases in the ILIAD database (time frame: July 2028). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00360646, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in