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

Part of paid clinical trials in Redwood City, California.

Sponsor
HepQuant, LLC
Study ID
NCT07060547
Status
Recruiting
Apply to this trial

Conditions

  • Alcohol-related Liver Disease
  • Alcoholic Hepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HepQuant DuO Test — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2031
Completion
Mar 31, 2032

Study Design

Enrollment
40 participants (estimated)

Primary Outcome Measure

Change in HepQuant Disease Severity Index (DSI) over time in patients with ALD [ Time Frame: From enrollment to 1 year past enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Dept. of Medicine -Gastroenterology & HepatologyRedwood CityCalifornia94063
Ethan Assistant Clinical Research Coordinating Associate, BA
[email protected]
650-460-6119
Allison Kwong, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University Dept. of Medicine -Gastroenterology & Hepatology· Redwood City, CA

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