Recruiting

HepQuant DuO

Sponsor:

HepQuant, LLC

Code:

NCT07060547

Conditions

Alcoholic Hepatitis

Alcohol-related Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HepQuant DuO Test

Study Details

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

Study ID

NCT07060547

Start date

Jun 10, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2032

Anticipated

Primary completion date

Dec, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

HepQuant DuO Test

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 outcome measure

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

Central Contacts and Locations

Locations

Stanford University Dept. of Medicine -Gastroenterology & Hepatology

Recruiting

Redwood City, California, United States, 94063

Contacts

Ethan Assistant Clinical Research Coordinating Associate, BA

650-460-6119eakamaga@stanford.edu

Principal Investigator:

Allison Kwong, MD

More Information

Sponsor

HepQuant, LLC

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by HepQuant, LLC on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.