DILIN - Prospective Study

Last updated: April 6, 2026
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT00345930
Pro00113362_1
Pro00072297
Pro00017208
5U01DK065176-11
U01DK065176
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 2 years at enrollment into the study.

  • Evidence of liver injury that is known or suspected to be related to consumption ofa 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 consecutiveblood 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" isdefined as the average of at least 2 measurements performed during the 12-monthperiod prior to starting the DILI medication.

  3. Any elevation of ALT, A P'ase, or AST, associated with (a) increased totalbilirubin [ ≥ 2.5 mg/dL], in absence of prior diagnosis of liver disease,Gilbert's syndrome, or evidence of hemolysis or (b) coagulopathy with INR > 1.5in absence of coumadin therapy or known vitamin K deficiency.

Exclusion

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 theinvestigator to be the primary reason for observed liver injury and supported bylaboratory tests, serologies, liver biopsy, or radiology.

  • Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primarysclerosing cholangitis, or other chronic biliary tract disease which may confoundthe ability to make a diagnosis of DILI.

  • Acetaminophen hepatotoxicity.

  • Liver/bone marrow transplant prior to the development of drug- or CAM-induced liverinjury.

Study Design

Total Participants: 4000
Study Start date:
September 01, 2004
Estimated Completion Date:
July 31, 2028

Study 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.

Connect with a study center

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • California Pacific Medical Center

    San Fransisco, California 94120
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202-5111
    United States

    Active - Recruiting

  • NIH Clinical Site

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109-0362
    United States

    Active - Recruiting

  • Mayo Clinic College of Medicane

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Univeristy of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599-7600
    United States

    Active - Recruiting

  • Albert Einstein

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Thomas Jefferson

    Philadelphia, Pennsylvania 19141
    United States

    Active - Recruiting

  • UT Soutwestern Medical Center at Dallas

    Dallas, Texas 75390
    United States

    Site Not Available

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