NCT07060547

Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: HepQuant, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Hepatitis
• Alcohol-related Liver Disease

Interventions

Type	Name	Description
DEVICE	HepQuant DuO Test	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.

Timeline

• Start date: 2025-06-10
• Primary completion: 2031-12-01
• Completion: 2032-03-01
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: United States