Recruiting

HepQuant DuO Test as Biomarker in Alcohol-related Liver Disease

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Study Aim

This observational study uses the HepQuant DuO test to see how the severity of alcohol-related liver disease changes over time, and how those changes relate to standard tests for measuring liver disease and outcomes.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Digestive System Diseases+6

+ Hepatitis

+ Hepatitis, Alcoholic

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: June 2025
See protocol details

Summary

Principal SponsorHepQuant, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 10, 2025

Actual date on which the first participant was enrolled.

This study aims to explore how well the liver recovers in individuals who have suffered liver damage related to alcohol use. It uses a special test called the HepQuant DuO to evaluate liver function and health. This blood-based test involves drinking a natural compound called cholate and then taking two blood samples at specific times. The participants in the study are individuals who have recently experienced alcohol-related liver injury. The goal is to gather information that can help better monitor and treat people with this condition, ultimately improving their care and outcomes. Participants in the study will visit an outpatient clinic four times over a year, specifically at 1, 3, 6, and 12 months. During each visit, they will take the HepQuant DuO test and undergo other routine medical tests. The study will also collect information about the participant's alcohol use, symptoms, and quality of life. One of the key measurements is the HepQuant Disease Severity Index (DSI), which ranges from 0, indicating no liver disease, to 50, indicating severe liver disease. This study seeks to understand how this index changes over time and how it relates to other standard tests for liver disease.

Official TitleInvestigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease
NCT07060547
Principal SponsorHepQuant, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesHepatitisHepatitis, AlcoholicLiver DiseasesLiver Diseases, AlcoholicSubstance-Related DisordersAlcohol-Related DisordersAlcohol-Induced DisordersChemically-Induced Disorders

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Stanford University Dept. of Medicine -Gastroenterology & Hepatology

Redwood City, United StatesOpen Stanford University Dept. of Medicine -Gastroenterology & Hepatology in Google Maps
Recruiting
One Study Center