Observational study on liver injuries from drugs and alternative medicines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify individuals who have experienced liver injuries due to idiosyncratic reactions from prescription drugs or complementary and alternative medicines (CAM). It is a multi-centered epidemiological effort that collects clinical data and biological specimens to develop a comprehensive database of recent drug-induced liver injury (DILI) cases. The study also seeks to identify risk factors associated with DILI and establish standardized terminology for better diagnosis and reporting. Additionally, it includes the use of Fibroscans for chronic subjects to assess liver health over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• NIH Clinical Site
  Bethesda, Maryland, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Univeristy of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Thomas Jefferson
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Huiman X. Barnhart, PhD — Duke University
• Study coordinator: Eilene Pham
• Email: eilene.pham@duke.edu
• Phone: 9196607253

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.