Alcoholic Hepatitis, Alcohol-related Liver Disease
Conditions
Brief 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. 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
DEVICEHepQuant 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.
Sponsors
HepQuant, LLC
Leland Stanford Junior University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HepQuant Disease Severity Index (DSI) over time in patients with ALD | 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. |
Countries
United States
Outcome results
None listed