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

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.

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Key information

Conditions

Alcoholic Hepatitis Alcohol-Induced Disorders Alcohol-Related Disorders Alcohol-related Liver Disease Chemically-Induced Disorders Digestive System Diseases Hepatitis Hepatitis, Alcoholic Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Dept. of Medicine -Gastroenterology & Hepatology

Redwood City, California, 94063, United States

Location status: Recruiting

Location contact

Allison Kwong, MD

PRINCIPAL_INVESTIGATOR

Ethan Assistant Clinical Research Coordinating Associate, BA

CONTACT

[email protected]

650-460-6119

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

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.

Primary outcomes

Change in HepQuant Disease Severity Index (DSI) over time in patients with ALD

Time frame: From enrollment to 1 year past enrollment

The objective of use of the HepQuant DuO test in this study is to evaluate how the HepQuant Disease Severity Index (DSI) changes over time in patients with alcohol-related liver disease (ALD) and to define the relationships of change in HepQuant DSI (ΔDSI) to the changes in the standard of care laboratory and imaging tests used for measuring severity of liver disease and clinical outcomes. The HepQuant DSI is a value on a scale of 0 to 50, where 0 indicates no liver disease and 50 indicates severe liver disease.

Sponsors and collaborators

Lead sponsor

HepQuant, LLC

Industry

Collaborators

Leland Stanford Junior University

Registry information

Important dates

Study start: 2025
Primary completion: 2031
Study completion: 2032
First posted: Jul 11, 2025
Registry last updated: Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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