Study Results
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Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2004-09-30
2028-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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2
Individuals without drug induced liver disease
No interventions assigned to this group
1
Individuals with drug induced liver disease
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
2 Years
ALL
Yes
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Huiman X. Barnhart, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Robert Fontana, MD
Role: STUDY_CHAIR
Univ. of Michiganl
Locations
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University of Southern California
Los Angeles, California, United States
Indiana University
Indianapolis, Indiana, United States
NIH Clinical Site
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Univeristy of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Thomas Jefferson
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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None Available
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Multi-center, Longitudinal Study of Drug- and CAM-Induced Liver Injury.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports biomedical research and disseminates research findings \& health information to the public.
Other Identifiers
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Pro00072297
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00017208
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00113362_1
Identifier Type: -
Identifier Source: org_study_id
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