Status:
RECRUITING
DILIN - Prospective Study
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Liver Diseases
Eligibility:
All Genders
2+ years
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 ...
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-induce...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT00345930
Start Date
September 1 2004
End Date
July 31 2028
Last Update
April 20 2025
Active Locations (6)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Indiana University
Indianapolis, Indiana, United States, 46202-5111
3
NIH Clinical Site
Bethesda, Maryland, United States, 20892
4
University of Michigan
Ann Arbor, Michigan, United States, 48109-0362