Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease

HepQuant

Status: Enrolling

Conditions: Alcoholic Hepatitis; Alcohol-related Liver Disease

Treatments: Device: HepQuant DuO Test

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT07060547

Stanford 78916

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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