Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00345930
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2006-06-27
Brief Title:
DILIN - Prospective Study
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Multi-Center Longitudinal Study of Drug-and CAM-Induced Liver Injury
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 gastroenterologisthepatologist 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
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 gastroenterologisthepatologist 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pro00017208 | OTHER | Original Duke IRB number | httpsreporternihgovquickSearchU01DK065176 |
| U01DK065176 | NIH | None | None |
| Pro00072297 | OTHER | None | None |