Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HepQuant DuO Test.
- Who it may be relevant to
- Registry conditions: Alcoholic Hepatitis, Alcohol-related Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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 measures
- Change in HepQuant Disease Severity Index (DSI) over time in patients with ALD [Time frame: From enrollment to 1 year past enrollment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Stanford University Dept. of Medicine -Gastroenterology & Hepatology — Redwood City
Identifiers
NCT: NCT07060547 · Stanford 78916