A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury
Duke University
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.
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 dif…
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- Yes
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: 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…
Locations (6)
- University of Southern CaliforniaLos Angeles, California
- Indiana UniversityIndianapolis, Indiana
- NIH Clinical SiteBethesda, Maryland
- University of MichiganAnn Arbor, Michigan
- Univeristy of North Carolina at Chapel HillChapel Hill, North Carolina
- Thomas JeffersonPhiladelphia, Pennsylvania