Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHepQuant, LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult with a clinical diagnosis of liver disease due to alcohol who have acute hepatic decompensation.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
HepQuant DuO Test
DeviceHepQuant 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
From enrollment to 1 year past enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
HepQuant, LLC
Lead sponsor
Leland Stanford Junior University
Collaborator
Source ClinicalTrials.gov