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Investigating HepQuant DuO Test for Alcohol-related Liver Disease

This study is looking at how well the HepQuant DuO Test can measure liver recovery in people with liver damage caused by alcohol. The HepQuant DuO Test is a blood test that involves drinking a natural compound called cholate and then having two blood samples taken. Researchers want to see how the HepQuant DuO Test's Disease Severity Index (DSI) changes over one year. You might be able to join if you are an adult with a liver disease diagnosis due to alcohol, especially if you have acute hepatic decompensation (a sudden worsening of liver function) or a combination of alcohol-related liver disease and nonalcoholic steatohepatitis (NASH). The study is currently recruiting 40 participants.

Study design
This is an observational study with 40 planned participants. It is not specified if it is randomized or blinded.
What's involved
You would have 4 outpatient clinic visits over one year (at 1, 3, 6, and 12 months). At each visit, you will have a HepQuant DuO test, other standard tests, and answer questions about your alcohol use, symptoms, and quality of life.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year after enrollment to measure changes in the HepQuant Disease Severity Index (DSI).

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NCT07060547

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

Recruiting
Not specifiedAges 18+Observational
HepQuant, LLC
~40 participants
Updated 2025-07-11 on ClinicalTrials.gov
What's tested:HepQuant DuO Test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in HepQuant Disease Severity Index (DSI) over time in patients with ALD
Measured over From enrollment to 1 year past enrollment

Conditions

Alcoholic Hepatitis
Alcohol-related Liver Disease

Explore related trials

Alcoholic HepatitisAlcohol-related Liver DiseaseNonalcoholic Steatohepatitis

Where it's being run

1 sites across 1 states
California1

Who to contact

Ethan Assistant Clinical Research Coordinating Associate, BA
[email protected]
650-460-6119
Email the study team

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Eligibility criteria

Inclusion

adult with a clinical diagnosis of liver disease due to alcohol who have acute hepatic decompensation.

Exclusion

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

What this trial measures

  • Change in HepQuant Disease Severity Index (DSI) over time in patients with ALDFrom 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.