HepQuant DuO blood test to track liver recovery after alcohol-related liver disease
Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease
HepQuant, LLC · NCT07060547
This tests whether the HepQuant DuO blood test can track liver recovery over one year in adults with alcohol-related liver disease or alcoholic hepatitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HepQuant, LLC (industry) |
| Locations | 1 site (Redwood City, California) |
| Trial ID | NCT07060547 on ClinicalTrials.gov |
What this trial studies
This observational study uses the HepQuant DuO, a blood-based test that involves a drink of the natural compound cholate and blood samples at 20 and 60 minutes, to measure liver physiology. Participants attend outpatient visits at 1, 3, 6, and 12 months during which the HepQuant DuO and standard clinical and laboratory tests are performed. The team collects clinical data, alcohol use history, symptoms, and quality-of-life measures to correlate HepQuant results with recovery. Data will be used to better monitor and treat people affected by alcohol-associated liver injury.
Who should consider this trial
Good fit: Adults (18+) with a clinical diagnosis of alcohol-related liver disease, including alcoholic hepatitis or combined ALD and NASH, who have experienced recent hepatic decompensation and can attend scheduled outpatient visits are the intended participants.
Not a fit: Patients whose liver disease is due primarily to non-alcohol causes, those with active solid-organ malignancy, autoimmune or genetic liver diseases, drug-induced liver injury, pregnant people, and those under 18 are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the HepQuant DuO could provide a convenient blood-based way to monitor liver recovery and help tailor follow-up and treatment for patients with alcohol-related liver injury.
How similar studies have performed: Prior pilot work has used HepQuant measurements to reflect liver function in other liver diseases, but applying the HepQuant DuO specifically to track recovery after alcohol-related liver injury is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Redwood City, California
- Stanford University Dept. of Medicine -Gastroenterology & Hepatology — Redwood City, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcoholic Hepatitis, Alcohol-related Liver Disease