Observational study on liver injuries from drugs and alternative medicines

A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury

This study is trying to find out how certain prescription drugs and alternative medicines can cause liver injuries in people, while also looking for risk factors and ways to improve diagnosis.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: Duke University (other)
• Locations: 6 sites (Los Angeles, California and 5 other locations)
• Trial ID: NCT00345930 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals over the age of 2 who have experienced liver injury suspected to be related to drug or CAM use within the last six months.

Not a fit: Patients who have not experienced liver injury or those with prior liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the understanding and management of liver injuries related to medications, potentially leading to better patient outcomes.

How similar studies have performed: Other studies have shown success in identifying drug-induced liver injuries, but this study's focus on CAM and its comprehensive approach is relatively novel.

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.

Where this trial is running

Los Angeles, California and 5 other locations

• 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

Conditions: Liver Diseases, Complementary and alternative medicine, Complementary therapies, Alternative therapies, Prescription Drugs, Non prescription Drugs, Liver Disease, Chemical Ind