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DILIN's Prospective Study

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ClinicalTrials.gov Identifier: NCT00345930
Recruitment Status : Recruiting
First Posted : June 29, 2006
Last Update Posted : April 27, 2022
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease
Liver Diseases

Detailed Description:

Liver injury due to prescription and non-prescription medication use is a medical, scientific and public health problem of increasing frequency and importance in the United States. Indeed, drug-induced liver injury (DILI) is the most important reason for non-approval, withdrawal, limitation in use and clinical monitoring by the Food and Drug Administration (FDA). However, detection of signals for liver injury frequently relies upon the reporting of cases by practitioners to health authorities in post-marketing surveillance. Under-reporting of cases, lack of mandatory reporting systems, and difficulties in establishing a diagnosis make the current system sub-optimal. Moreover, with the growing use of complementary and alternative medications (CAM), there have also been increasing reports of liver toxicity due to various non-prescription herbal, dietary and food additive supplements. Because the manufacturing, dispensing and testing of these products is not regulated, the hepatotoxic potential of these formulations is poorly characterized or completely unknown.

The DILIN Prospective Study is a multi-centered epidemiological study designed to gather clinical information and biological specimens on cases of suspected liver injury due to drugs and CAM. The goals of this study are to develop a database of recent DILI cases, identify the clinical, environmental and genetic risk factors that predict DILI, develop standardized instruments and terminology and perform careful longitudinal follow-up of DILI subjects. Biological samples collected will be used in future studies of the mechanisms and genetics of DILI.

Patients who are referred to one of the DILIN clinical sites and who, in the opinion of gastroenterologist/hepatologist, experienced a drug-induced liver injury are enrolled. Detailed clinical data and biological specimens are collected. Clinical data will be reviewed by the DILIN Causality Committee and the final determination on whether the subject qualifies as a bona fide DILI case is made by consensus opinion. DILI cases (only) are followed for at least 6 months to derive the longitudinal profile of drug-and CAM-induced liver injury. Detailed clinical data including liver elastography (FibroScans) and biological specimens are collected. Patients who satisfy the definition of chronic DILI will be evaluated with additional FibroScans at 12, 24, 36 and 48 months thereafter.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury
Study Start Date : September 2004
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Individuals without drug induced liver disease
Individuals with drug induced liver disease

Biospecimen Retention:   Samples With DNA
Samples with DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have suffered a drug induced liver injury and meet inclusion and exclusion criteria

Inclusion 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.

Exclusion Criteria:

Patients with any of the following will not be eligible for participation:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345930

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Contact: Katherine Galan, RN 919-668-8579 katherine.galan@duke.edu
Contact: Matt Baum 919-668-0486 matt.baum@duke.edu

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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Susan Milstein, RN, BSN    323-224-5441    smilstei@usc.edu   
Contact: None Available         
Principal Investigator: Andrew Stolz, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202-5111
Contact: Jennifer Terrel    317-278-6266    jkramey@iu.edu   
Principal Investigator: Naga P Chalasani, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-0362
Contact: Andrew Tucker    734-936-4886    andrewtu@med.umich.edu   
Principal Investigator: Robert J Fontana, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Umair Masood    212-659-8369    umair.masood@mssm.edu   
Contact: Jospeph odin, MD    212-241-8035    joseph.odin@mountsinai.org   
United States, North Carolina
Univeristy of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7600
Contact: Tracy Russell    919-843-2376    trussell@med.unc.edu   
Contact: None Available         
Principal Investigator: Paul B Watkins, MD         
United States, Pennsylvania
Albert Einstein Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Katrin Koy    215-456-2004    koykatri@einstein.edu   
Principal Investigator: Victor J Navarro, MD         
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Huiman X. Barnhart, PhD Duke University
Study Chair: Robert Fontana, MD Univ. of Michiganl
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00345930    
Other Study ID Numbers: Pro00017208_1
5U01DK065176-11 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: January 2022
Keywords provided by Duke University:
Complementary and alternative medicine
Complementary therapies
Alternative therapies
Prescription Drugs
Non prescription Drugs
Liver Disease
Chemical Ind
Cholestatic Liver Injury
Hepatocellular Liver Injury
Mixed Liver Injury
Matched Case Control Studies
Liver Dis
Chem Ind
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases