Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Duke University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
---|---|
Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00345930 |
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.
Condition |
---|
Liver Diseases |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury |
Samples without DNA
Estimated Enrollment: | 450 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | August 2008 |
Groups/Cohorts |
---|
2
Individuals without drug induced liver disease
|
1
Individuals with drug induced liver disease
|
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.
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:
Documented clinically important DILI, defined as any of the following:
Exclusion Criteria:
Patients with any of the following will not be eligible for participation:
Contact: Mary V Moggio, MSPH | 919-668-8819 | mary.moggio@duke.edu |
Contact: Satarah Latiker | 919-668-8952 | satarah.latiker@duke.edu |
United States, California | |
University of California at San Francisco | Recruiting |
San Fransisco, California, United States, 94143 | |
Contact: None Available | |
Contact: Maurizio Bonacini, MD 415-605-1026 bonacim@itsa.ucsf.edu | |
Principal Investigator: Timothy J Davern, MD | |
United States, Connecticut | |
University of Connecticut Health Center | Recruiting |
Farmington, Connecticut, United States, 06030-1111 | |
Contact: Mariola Smialek 860-679-2996 smialek@uchc.edu | |
Principal Investigator: Petr Protiva, MD | |
United States, Indiana | |
Indiana University | Recruiting |
Indianapolis, Indiana, United States, 46202-5111 | |
Contact: Audrey Corne, RN, CCRN 317-287-3062 acorne@iupui.edu | |
Contact: Debbie Breed 317-274-3505 dbreed@iupui.edu | |
Principal Investigator: Naga P Chalasani, MD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109-0362 | |
Contact: Suzanne Welch 734-936-4886 swelc@umich.edu | |
Contact: Jordan Kridler 734-936-4886 | |
Principal Investigator: Robert J Fontana, MD | |
United States, North Carolina | |
Univeristy of North Carolina at Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7600 | |
Contact: Susan Pusek, MPH 919-966-0128 suspusek@med.unc.edu | |
Contact: Anne Criss 919-966-6022 abcriss@med.unc.edu | |
Principal Investigator: Paul B Watkins, MD |
Principal Investigator: | James Rochon, PhD | Duke University |
Study Chair: | Paul Watkins, MD | The University of North Carolina, Chapel Hill |
Principal Investigator: | John McHutchison, MD | Duke University |
Responsible Party: | Duke Clinical Research Institute ( James Rochon, PhD ) |
Study ID Numbers: | 5 U01-DK065176-05 |
Study First Received: | June 27, 2006 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00345930 |
Health Authority: | United States: Institutional Review Board |
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 |
Liver Diseases Digestive System Diseases |