DILIN's Prospective Study
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| ClinicalTrials.gov Identifier: NCT00345930 |
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Recruitment Status :
Recruiting
First Posted : June 29, 2006
Last Update Posted : April 19, 2018
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| Condition or disease |
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| Liver Diseases |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 1600 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 : | July 2022 |
| Estimated Study Completion Date : | July 2022 |
| Group/Cohort |
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2
Individuals without drug induced liver disease
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1
Individuals with drug induced liver disease
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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 |
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.
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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.
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.
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
| Contact: Katherine Galan, RN | 919-668-8579 | katherine.galan@duke.edu | |
| Contact: Theresa O'Rielly | 919-668-8465 | theresa.o'rielly@duke.edu |
| 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: Audrey Corne, RN ,EdD 317-278-3062 acorne@iu.edu | |
| Principal Investigator: Naga P Chalasani, MD | |
| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0362 | |
| Contact: Ben Johnson 734-936-4886 kendalld@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: Stephanie Pagan stephanie.pagan@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: Manisha Verma, MD MPH 215-456-2480 VegaMari@einstein.edu | |
| Principal Investigator: Victor J Navarro, MD | |
| Principal Investigator: | Huiman X. Barnhart, PhD | Duke University | |
| Study Chair: | Paul Watkins, MD | University of North Carolina, Chapel Hill |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00345930 History of Changes |
| 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 19, 2018 |
| Last Verified: | April 2018 |
Keywords provided by Duke University:
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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:
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Liver Diseases Digestive System Diseases |