Drug-Induced Liver Injury (DILI) Network Retrospective

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.

Conditions

Drug Induced Liver Injury

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Study Overview

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Study Details

Study overview

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.

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

Drug-Induced Liver Injury (DILI) Network Retrospective

Condition
Drug Induced Liver Injury
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southen California, Los Angeles, California, United States, 90033

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202-5111

Bethesda

NIH Clinical Site, Bethesda, Maryland, United States, 20892

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109-0362

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Chapel Hill

Univeristy of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States, 27599-7600

Philadelphia

Thomas Jefferson, Philadelphia, Pennsylvania, United States, 19141

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

2 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Duke University,

Huiman X. Barnhart, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Robert Fontana, MD, STUDY_CHAIR, University of Michigan

Study Record Dates

2028-07-31