HepQuant DuO Test as Biomarker in Alcohol-related Liver Disease
This observational study uses the HepQuant DuO test to see how the severity of alcohol-related liver disease changes over time, and how those changes relate to standard tests for measuring liver disease and outcomes.
Data Collection
Collected from today forward - ProspectiveDigestive System Diseases+6
+ Hepatitis
+ Hepatitis, Alcoholic
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: June 10, 2025
Actual date on which the first participant was enrolled.This study aims to explore how well the liver recovers in individuals who have suffered liver damage related to alcohol use. It uses a special test called the HepQuant DuO to evaluate liver function and health. This blood-based test involves drinking a natural compound called cholate and then taking two blood samples at specific times. The participants in the study are individuals who have recently experienced alcohol-related liver injury. The goal is to gather information that can help better monitor and treat people with this condition, ultimately improving their care and outcomes. Participants in the study will visit an outpatient clinic four times over a year, specifically at 1, 3, 6, and 12 months. During each visit, they will take the HepQuant DuO test and undergo other routine medical tests. The study will also collect information about the participant's alcohol use, symptoms, and quality of life. One of the key measurements is the HepQuant Disease Severity Index (DSI), which ranges from 0, indicating no liver disease, to 50, indicating severe liver disease. This study seeks to understand how this index changes over time and how it relates to other standard tests for liver disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Stanford University Dept. of Medicine -Gastroenterology & Hepatology
Redwood City, United StatesOpen Stanford University Dept. of Medicine -Gastroenterology & Hepatology in Google Maps