Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease
HepQuant, LLC
40 participants
Jun 10, 2025
OBSERVATIONAL
Conditions
Summary
This is a study to measure liver recovery in patients with recent alcohol-associated liver injury by assessing liver function and physiology using HepQuant DuO. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and 2 blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data to better monitor and treat patients who have been affected by alcohol-associated liver disease. The study has 4 visits at an outpatient clinic at 1, 3, 6, and 12 months. At each of these visits, participants will undergo a HepQuant DuO test and other standard tests. In addition, the study team will ask about a participant's alcohol use, symptoms, and quality of life.
Eligibility
Inclusion Criteria2
- adult with a clinical diagnosis of liver disease due to alcohol who have acute hepatic decompensation.
- adult with a combined clinical diagnosis of alcohol-related liver disease (ALD) and nonalcoholic steatohepatitis (NASH).
Exclusion Criteria5
- Clinical diagnosis of liver disease with an etiology other than alcohol liver disease unless it is a combined clinical diagnosis of ALD and NASH.
- patients with solid organ malignancy.
- patients with other disease affecting the liver including autoimmune, drug-related liver injury, hemochromatosis or Wilson's disease
- pregnancy
- under the age of 18
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Interventions
HepQuant DuO is commercially available in the U.S. as a Laboratory Developed Test (LDT), but it will be used in this study as a nonsignificant risk investigational device to measure change in liver function over time.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07060547