RECRUITING

DILIN - Prospective Study

Conditions

Liver Diseases Complementary and alternative medicine Complementary therapies Alternative therapies Prescription Drugs Non prescription Drugs Liver Disease Chemical Ind Phenotype Proteomics Metabolomics Cholestatic Liver Injury Hepatocellular Liver Injury Mixed Liver Injury Matched Case Control Studies Genotype Liver Dis Chem Ind

Quick Navigation

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 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.

Official Title

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

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

NCT00345930

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:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Eilene Pham

CONTACT

9196607253

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

Univ. of Michiganl

Study Locations (Sites)

University of Southern 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, Univ. of Michiganl

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

Complementary and alternative medicine
Complementary therapies
Alternative therapies
Prescription Drugs
Non prescription Drugs
Liver Disease
Chemical Ind
Phenotype
Proteomics
Metabolomics
Cholestatic Liver Injury
Hepatocellular Liver Injury
Mixed Liver Injury
Matched Case Control Studies
Genotype
Liver Dis
Chem Ind

Additional Relevant MeSH Terms

Liver Diseases