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Massive study tracks hidden liver dangers of common drugs and herbal remedies

NCT ID NCT00345930

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 collect detailed information from 4,000 people who have experienced liver injury possibly caused by prescription drugs or complementary and alternative medicines. Researchers will track participants over time, using blood tests and liver scans to better understand how these injuries happen and how they progress. The goal is to build a database that helps doctors recognize and manage such injuries in the future.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better identify which drugs or supplements cause liver injury and how to prevent it.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly help participants. It may take years to gather enough data for meaningful conclusions.

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 4,000 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 who have suffered a drug induced liver injury and meet inclusion and exclusion criteria

Ages

2 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 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: 1. ALT or AST \>5 x ULN or A P'ase \>2 x ULN confirmed on at least 2 consecutive blood draws in patients with previously normal values. 2. If baseline (BL) ALT, AST or A P'ase are known to be elevated, then ALT or AST \>5 x BL or A P'ase \>2 x BL on at least 2 consecutive blood draws. "Baseline" is defined as the average of at least 2 measurements performed during the 12-month period prior to starting the DILI medication. 3. Any elevation of ALT, A P'ase, or AST, associated with (a) increased total bilirubin \[ ≥ 2.5 mg/dL\], in absence of prior diagnosis of liver disease, Gilbert's syndrome, or evidence of hemolysis or (b) coagulopathy with INR \> 1.5 in absence of coumadin therapy or known vitamin K deficiency. Exclusion Criteria: Patients with any of the following will not be eligible for participation: * 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.

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Conditions

The condition(s) this trial relates to.

drug-induced liver injury liver disorder

As listed by the trial registrant

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

Liver diseases

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 Southern California

    RECRUITING

    Los Angeles, California, 90033, United States

More trials for these conditions

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