RECRUITING

Drug-Induced Liver Injury (DILI) Network Retrospective

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2004-09
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT00360646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The treating gastroenterologist / hepatologist or health care professional must believe that the subject suffered drug-induced liver injury;
  2. * The subject must be alive and the date of onset of the qualifying DILI episode must have occurred on or after January 1, 1994;
  3. * Evidence of injury that is known or suspected to be related to consumption of a drug or HDS/CAM product
  4. * 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;
  5. * Have clinically important DILI defined in terms of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (Alk Phos).
  6. * Sufficient documentation of the event for the Causality Committee to make a determination.
  1. * are not willing to have medical information and blood samples taken;
  2. * are unable to adequately give informed consent to participate in the study including the blood draw for the genetic component;
  3. * age \< 2 years old at the time of study enrollment (due to blood volume requirements).
  4. * 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.

Contacts and Locations

Study Contact

Eilene Pham
CONTACT
919-660-7253
eilene.pham@duke.edu
Matt Baum
CONTACT
919-668-0486
matt.baum@duke.edu

Principal Investigator

Huiman X. Barnhart, PhD
PRINCIPAL_INVESTIGATOR
Duke University
Robert Fontana, MD
STUDY_CHAIR
University of Michigan

Study Locations (Sites)

University of Southen California
Los Angeles, California, 90033
United States
Indiana University
Indianapolis, Indiana, 46202-5111
United States
NIH Clinical Site
Bethesda, Maryland, 20892
United States
University of Michigan
Ann Arbor, Michigan, 48109-0362
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7600
United States
Thomas Jefferson
Philadelphia, Pennsylvania, 19141
United States

Collaborators and Investigators

Sponsor: Duke University

  • Huiman X. Barnhart, PhD, PRINCIPAL_INVESTIGATOR, Duke University
  • Robert Fontana, MD, STUDY_CHAIR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2004-09
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2004-09
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • LIVER DIS
  • CHEM IND
  • Drugs
  • Drug induced liver injury
  • phenotype
  • cholestatic liver injury
  • hepatocellular liver injury
  • mixed liver injury
  • genotype

Additional Relevant MeSH Terms

  • Drug Induced Liver Injury