NCT00345930

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Sep 2004

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Sep 2004Jul 2028

Study Start

First participant enrolled

September 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
22.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

23.9 years

First QC Date

June 27, 2006

Last Update Submit

April 6, 2026

Conditions

Liver Diseases

Keywords

Complementary and alternative medicineComplementary therapiesAlternative therapiesPrescription DrugsNon prescription DrugsLiver DiseaseChemical IndPhenotypeProteomicsMetabolomicsCholestatic Liver InjuryHepatocellular Liver InjuryMixed Liver InjuryMatched Case Control StudiesGenotypeLiver DisChem Ind

Outcome Measures

Primary Outcomes (1)

  • Develop a database of recent DILI cases

    develop a database of recent DILI cases

    July 2028

Study Arms (2)

2

Individuals without drug induced liver disease

1

Individuals with drug induced liver disease

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have suffered a drug induced liver injury and meet inclusion and exclusion criteria

You may qualify if:

  • 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:
  • 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.
  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202-5111, United States

RECRUITING

NIH Clinical Site

Bethesda, Maryland, 20892, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109-0362, United States

RECRUITING

Univeristy of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7600, United States

RECRUITING

Thomas Jefferson

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

Related Publications (10)

  • Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J; DILIN Study Group. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55-68. doi: 10.2165/00002018-200932010-00005.

    PMID: 19132805BACKGROUND

  • Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology. 2008 Dec;135(6):1924-34, 1934.e1-4. doi: 10.1053/j.gastro.2008.09.011. Epub 2008 Sep 17.

    PMID: 18955056BACKGROUND

  • Gopalakrishna H, Ghabril M, Gu J, Li YJ, Fontana RJ, Kleiner DE, Koh C, Chalasani N; Drug-Induced Liver Injury Network. Drug-induced Liver Injury Due to Medications for Alcohol Use Disorder: Results From the DILIN Prospective Study. J Addict Med. 2025 May-Jun 01;19(3):314-321. doi: 10.1097/ADM.0000000000001421. Epub 2024 Dec 9.

    PMID: 39651750DERIVED

  • Fontana RJ, Kleiner DE, Chalasani N, Bonkovsky H, Gu J, Barnhart H, Li YJ, Hoofnagle JH. The Impact of Patient Age and Corticosteroids in Patients With Sulfonamide Hepatotoxicity. Am J Gastroenterol. 2023 Sep 1;118(9):1566-1575. doi: 10.14309/ajg.0000000000002232. Epub 2023 Feb 27.

    PMID: 36848311DERIVED

  • Fontana RJ, Engle RE, Hayashi PH, Gu J, Kleiner DE, Nguyen H, Barnhart H, Hoofnagle JH, Farci P. Incidence of Hepatitis E Infection in American Patients With Suspected Drug-Induced Liver Injury Is Low and Declining: The DILIN Prospective Study. Am J Gastroenterol. 2022 Sep 1;117(9):1462-1470. doi: 10.14309/ajg.0000000000001869. Epub 2022 Jun 10.

    PMID: 35973149DERIVED

  • Devarbhavi H, Ghabril M, Barnhart H, Patil M, Raj S, Gu J, Chalasani N, Bonkovsky HL. Leflunomide-induced liver injury: Differences in characteristics and outcomes in Indian and US registries. Liver Int. 2022 Jun;42(6):1323-1329. doi: 10.1111/liv.15189. Epub 2022 Feb 15.

    PMID: 35129282DERIVED

  • Vuppalanchi R, Bonkovsky HL, Ahmad J, Barnhart H, Durazo F, Fontana RJ, Gu J, Khan I, Kleiner DE, Koh C, Rockey DC, Phillips EJ, Li YJ, Serrano J, Stolz A, Tillmann HL, Seeff LB, Hoofnagle JH, Navarro VJ; Drug-Induced Liver Injury Network. Garcinia cambogia, Either Alone or in Combination With Green Tea, Causes Moderate to Severe Liver Injury. Clin Gastroenterol Hepatol. 2022 Jun;20(6):e1416-e1425. doi: 10.1016/j.cgh.2021.08.015. Epub 2021 Aug 14.

    PMID: 34400337DERIVED

  • Martinez MA, Vuppalanchi R, Fontana RJ, Stolz A, Kleiner DE, Hayashi PH, Gu J, Hoofnagle JH, Chalasani N. Clinical and histologic features of azithromycin-induced liver injury. Clin Gastroenterol Hepatol. 2015 Feb;13(2):369-376.e3. doi: 10.1016/j.cgh.2014.07.054. Epub 2014 Aug 9.

    PMID: 25111234DERIVED

  • Navarro VJ, Barnhart H, Bonkovsky HL, Davern T, Fontana RJ, Grant L, Reddy KR, Seeff LB, Serrano J, Sherker AH, Stolz A, Talwalkar J, Vega M, Vuppalanchi R. Liver injury from herbals and dietary supplements in the U.S. Drug-Induced Liver Injury Network. Hepatology. 2014 Oct;60(4):1399-408. doi: 10.1002/hep.27317. Epub 2014 Aug 25.

    PMID: 25043597DERIVED

  • Ghabril M, Bonkovsky HL, Kum C, Davern T, Hayashi PH, Kleiner DE, Serrano J, Rochon J, Fontana RJ, Bonacini M; US Drug-Induced Liver Injury Network. Liver injury from tumor necrosis factor-alpha antagonists: analysis of thirty-four cases. Clin Gastroenterol Hepatol. 2013 May;11(5):558-564.e3. doi: 10.1016/j.cgh.2012.12.025. Epub 2013 Jan 17.

    PMID: 23333219DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Samples with DNA

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Huiman X. Barnhart, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Robert Fontana, MD

    Univ. of Michiganl

    STUDY CHAIR

Central Study Contacts

Eilene Pham

CONTACT

9196607253eilene.pham@duke.edu

Matt Baum

CONTACT

919-668-0486matt.baum@duke.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2006

First Posted

June 29, 2006

Study Start

September 1, 2004

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

April 8, 2026

Record last verified: 2026-04

Locations

US(6)