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

NCT07060547 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-07-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Leland Stanford Junior University

    collaborator UNKNOWN

  • HepQuant, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2031-12-31
Completion
2032-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07060547 on ClinicalTrials.gov