DILIN - Prospective Study

Description

The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.

Conditions

Liver Diseases

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Study Overview

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Study Details

Study overview

The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.

A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury

DILIN - Prospective Study

Condition
Liver Diseases
Intervention / Treatment

-

Contacts and Locations

Los Angeles

University of Southern 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

  • * 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.
  • * 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.

Ages Eligible for Study

2 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Huiman X. Barnhart, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Robert Fontana, MD, STUDY_CHAIR, Univ. of Michiganl

Study Record Dates

2028-07-31