Registry for patients with drug-induced liver injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create a nationwide registry of patients who have experienced drug-induced liver injury (DILI) by collecting and storing biological specimens such as serum, DNA, and lymphocytes. The registry will serve as a resource for future research into the mechanisms behind severe idiosyncratic DILI. Patients who meet specific criteria will be included, and their clinical data will be documented to facilitate further investigations. The study will also maintain a database for potential future contact with participants.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Southen California
  Los Angeles, California, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• NIH Clinical Site
  Bethesda, Maryland, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Univeristy of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Thomas Jefferson
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Huiman X. Barnhart, PhD — Duke University
• Study coordinator: Eilene Pham
• Email: eilene.pham@duke.edu
• Phone: 919-660-7253

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treating acute drug-induced liver injury with high bilirubin using steroids

  This trial will test whether adding glucocorticoid (steroid) treatment to standard care helps adults with acute drug‑induced liver injury and high bilirubin recover faster and avoid worsening liver problems.

  Recruiting General Hospital of Shenyang Military Region · Shenyang, Liaoning · NCT06922669

• Comparing two diagnostic methods for drug-induced liver injury

  This study is testing two different scoring systems to see which one better helps doctors diagnose drug-induced liver injury in hospitalized patients.

  Recruiting Beijing Friendship Hospital · Beijing, Beijing Municipality · NCT06771011

• Understanding itching caused by drug-induced liver injury

  This study looks at how common itching is for people with drug-induced liver injury to better understand it and help find new treatments.

  Recruiting University of Nottingham · Nottingham · NCT06446609

• Prognostic model for drug-induced liver injury in China

  This study is trying to understand the causes and outcomes of drug-induced liver injury in China to help create a better tool for predicting how patients will do.

  Recruiting at 9 sites Beijing Friendship Hospital · Beijing, Beijing Municipality and 12 other locations · NCT05060289

• Identifying genetic factors for acetaminophen-induced liver injury in Chinese patients

  This study is trying to find out if certain genes make Chinese patients more likely to have liver problems from taking acetaminophen.

  Recruiting The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT04964310

• Observational study on drug-induced liver injury in China

  This study looks at how drug-induced liver injury affects patients in China to better understand its causes and how it progresses, especially in different age groups and health conditions.

  Recruiting Drug Induced Liver Disease Study Group · Shanghai · NCT02961413

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.