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

NCT07060547 | Recruiting

• 1 other identifier: Stanford 78916
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  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.

  From enrollment to 1 year past enrollment

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Identify patients through an automated report run in electronic medical record and notifications by treating physicians on the hepatology consult service. No recruitment materials (e.g. flyers) will be used as all patients are identified and enrolled as inpatients. Potential participants identified during the chart review will be notified that they may be eligible for this research study by their primary inpatient medical team (MD). Patients will be contacted only after the patient's physician has previously notified the potential research participant and obtained approval for such contact.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• HepQuant, LLC: lead
• Leland Stanford Junior University: collaborator

Study Sites (1)

Stanford University Dept. of Medicine -Gastroenterology & Hepatology

Redwood City, California, 94063, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis, Alcoholic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: July 11, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): March 1, 2032
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)