DILIN's Prospective Study
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Purpose
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.
| Condition |
|---|
|
Liver Diseases |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury |
Samples with DNA
| Estimated Enrollment: | 900 |
| Study Start Date: | September 2004 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
2
Individuals without drug induced liver disease
|
|
1
Individuals with drug induced liver disease
|
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 and biological specimens are collected. Patients who satisfy the definition of chronic DILI will be evaluated at 12 months and 24 months thereafter.
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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:
- 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00345930
| Contact: Katherine Galan, RN | 919-668-8579 | katherine.galan@duke.edu | |
| Contact: Nidia Rosado | 305-974-0424 | nidia.rosado@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: Kristen Chesney, MBA 734-936-4886 kches@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: Joseph Odin, MD 212-241-8035 joseph.odin@mountsinai.org | |
| Contact: Jawad Ahmad, MD 212-241-8035 jawad.ahmad@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: Maricruz Velez, MPH 215-456-2480 VegaMari@einstein.edu | |
| Contact: Manisha Verma, MD MPH 215-456-1026 vermam@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 |
More Information
Additional Information:
Publications:
Additional 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, 5 U01-DK065176-11 |
| Study First Received: | June 27, 2006 |
| Last Updated: | February 6, 2015 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
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:
|
Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on February 27, 2015