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DILIN - Prospective Study for Drug-Induced Liver Injury

This study aims to create a database of people who have experienced liver injury due to prescription drugs or complementary and alternative medicines (CAMs). Researchers want to understand more about these reactions, which are a growing concern. You might be able to join if you are over 2 years old and have experienced liver injury suspected to be from a drug or CAM within the last six months. The main goal is to build this database by July 2028. The study will also include Fibroscans (a test to check liver health) for some participants at the beginning and during follow-up.

Study design
This is an observational study, meaning researchers will collect information without giving any specific interventions. It plans to enroll about 4000 participants.
What's involved
Fibroscans will be completed at baseline and during follow-up for chronic subjects. Other specific procedures or visit schedules are not detailed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for developing the database is measured at July 2028, suggesting follow-up will continue until at least that time for data collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00345930

DILIN - Prospective Study

Recruiting
Not specifiedAges 2+Observational
Duke University
~4,000 participants
Updated 2026-04-08 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Develop a database of recent DILI cases
Measured over July 2028

Conditions

Liver Diseases

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NCT00345930

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Indiana University

    Indianapolis, Indianastudy coordinator listed

    Recruiting

  • NIH Clinical Site

    Bethesda, Marylandstudy coordinator listed

    Recruiting

  • Thomas Jefferson

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Univeristy of North Carolina at Chapel Hill

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

  • University of Michigan

    Ann Arbor, Michiganstudy coordinator listed

    Recruiting

  • University of Southern California

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Huiman X. Barnhart, PhD · PRINCIPAL_INVESTIGATOR · Duke University
  • Robert Fontana, MD · STUDY_CHAIR · Univ. of Michiganl

Who to contact

Eilene Pham
[email protected]
9196607253
Email the study team

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Eligibility criteria

Inclusion

Age \> 2 years at enrollment into the study.
Evidence of liver injury that is known or suspected to be related to consumption of a drug or CAM product in the 6-month period prior to enrollment.
Written Informed consent from the patient or the patient's legal guardian.
Documented clinically important DILI, defined as any of the following:

Exclusion

Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be the primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy, or radiology.
Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease which may confound the ability to make a diagnosis of DILI.
Acetaminophen hepatotoxicity.
Liver/bone marrow transplant prior to the development of drug- or CAM-induced liver injury.

What this trial measures

  • Develop a database of recent DILI casesJuly 2028

    develop a database of recent DILI cases