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New study collects data and samples to unlock mysteries of Drug-Induced liver damage

NCT ID NCT00360646

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to create a nationwide registry of 400 people who have experienced drug-induced liver injury (DILI). Researchers will collect medical information and biological samples like blood and DNA to build a resource for future studies. The goal is to better understand why some drugs cause severe liver damage in certain people. Participants must have had DILI since 1994 and be alive to join.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2004

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

drug-induced liver injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Drug-induced liver injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202-5111, United States

  • NIH Clinical Site

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • Thomas Jefferson

    RECRUITING

    Philadelphia, Pennsylvania, 19141, United States

  • Univeristy of North Carolina at Chapel Hill

    RECRUITING

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

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109-0362, United States

  • University of Southen California

    RECRUITING

    Los Angeles, California, 90033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.