Alcoholic HepatitisNCT07060547
Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease
An observational study of Alcoholic Hepatitis and Alcohol-related Liver Disease, run by HepQuant, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholic Hepatitis, Alcohol-related Liver Disease
- What is being tested?
- HepQuant DuO Test
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2025to Mar 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University Dept. of Medicine -Gastroenterology & Hepatology
Redwood City, California, 94063
Ethan Assistant Clinical Research Coordinating Associate, BA, 650-460-6119, eakamaga@stanford.edu
Allison Kwong, MD
About this study
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
- Being tested
- HepQuant DuO Test
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepQuant DuO TestDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 1 year past enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Jun 2025
- Primary completionDec 2031 (estimated)
- Study completionMar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HepQuant, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Leland Stanford Junior University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060547
- Sponsor's protocol ID
- Stanford 78916
- Status last verified
- Sep 2026
- First submitted
- 13 May 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease
- ClinicalTrials.gov ID
- NCT07060547
- Acronym / sponsor ID
- Stanford 78916
- Conditions
- Alcoholic Hepatitis, Alcohol-related Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HepQuant, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Leland Stanford Junior University
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepQuant DuO TestHepQuant 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. | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stanford University Dept. of Medicine -Gastroenterology & Hepatology
Redwood City, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcoholic Hepatitis and Alcohol-related Liver Disease, run by HepQuant, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.