Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Leland Stanford Junior University | UNKNOWN |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HepQuant DuO Test | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 1 year past enrollment |
Not provided
Not provided
Inclusion Criteria:
adult with a combined clinical diagnosis of alcohol-related liver disease (ALD) and nonalcoholic steatohepatitis (NASH).
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Dept. of Medicine -Gastroenterology & Hepatology | Recruiting | Redwood City | California | 94063 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
Not provided
Not provided
Not provided
Not provided
Not provided
| D020751 |
| Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |