DILIN - Prospective Study

Launched by DUKE UNIVERSITY · Jun 28, 2006

Keywords

ClinConnect Summary

The DILIN Prospective Study is investigating liver injuries caused by certain prescription drugs or alternative medicines. The goal is to find and better understand individuals who have experienced these types of liver injuries. Recently, the study has expanded to include new patients who have had acute liver injuries and will use a non-invasive test called Fibroscan to check liver health at the beginning and during follow-up visits for those with ongoing issues.

To participate in this study, you or your child must be over 2 years old and have signs of liver injury linked to a medication or alternative treatment within the last six months. It's important to have consent from a parent or guardian if the participant is a minor. Participants will undergo tests to confirm liver injury and will be monitored throughout the study. However, certain conditions, like existing liver diseases or previous liver transplants, may prevent someone from joining the study. This research aims to provide better insights into drug-induced liver injuries and improve care for affected individuals.

Gender

ALL

Eligibility 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:
• • 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 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.
• • 3. 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.