Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient testing in patients with liver disease.

Detailed Description
-----------------
The goal of this study is to demonstrate the HQ-SHUNT is safe, simple to administer, noninvasive, cost-effective, and well tolerated by patients. This study will compare the HQ-SHUNT to Hepatic Venous Pressure Gradient (HVPG) testing. In this study, 100 consecutive patients with various etiologies of liver disease who have undergone technically successful HVPG testing as standard of care will also undergo HQ-SHUNT testing.

Official Title
-----------------
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Drug: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)
* Device: Hepatic Venous Pressure Gradient (HVPG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver disease patient scheduled to have an Hepatic Venous Pressure Gradient (HVPG) procedure At time of enrollment, being between the ages of 18 and 75 Exclusion Criteria: Concomitant treatment with both a beta blocker and an ACE inhibitor Concurrent hepatic malignancy. Patients with a history of treated HCC can be included if there is no evidence of recurrent disease at the time of this study. Unstable angina or history of myocardial infarction or congestive heart failure within 6 months prior to enrollment into this study Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2) Crohn's disease or any active intestinal inflammatory condition Having had an ileal resection Diabetic Gastroparesis Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed prior to HQ SHUNT testing. Inability to consent for one's self

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: (HVPG) and HepQuant-SHUNT (HQ-Shunt)<br>Successful Hepatic Venous Pressure Gradiant (HVPG) testing is required prior to administration of the HepQuant-SHUNT test. Comparison of Disease Severity Index (DSI) from HQ-SHUNT with HVPG in identifying patients with cirrhosis and patients with varices. | Drug: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)<br>* The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease<br>* Other names: HQ-SHUNT;Device: Hepatic Venous Pressure Gradient (HVPG)<br>* Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease<br>* Other names: (HVPG);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1) | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes | 
| Results of HepQuant SHUNT Test: Systemic Clearance | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. Systemic Clearance (13C-CA; ml min-1) | Up to 90 minutes | 
| Results of HepQuant SHUNT Test: Apparent Portal Clearance | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes | 
| Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes | 
| Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. | Up to 90 minutes | 
| Results of HepQuant SHUNT Test: SHUNT | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. SHUNT% is The percent of the oral dose of cholate that escapes hepatic extraction | Up to 90 minutes | 
| Results of HepQuant SHUNT Test: DSI Score | Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. DSI range is from 0 to 50. 0 implies no disease; 50 implies severe end-stage disease. | Up to 90 minutes | 
| Results of HepQuant SHUNT Test: STAT | Compare HepQuant STAT test from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension. HepQuant STAT is a simple drink and draw blood-based clearance test that quantifies hepatic impairment from early through late stages of disease. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures. | Overall experience and willingness to repeat 0-10 Scale 0 being no pain, 10 being severe pain 0 being no discomfort, 10 being severe discomfort 0 being no interference with daily life, 10 being unable to carry on activities 0 being very negative experience, 10 being very positive experience 0 being definitely not wanting to have the test again, 10 being very willing to have the test again | Immediately post HepQuant SHUNT test (Baseline up to Day 60) | 
| Hours for Test | Number of hours it took for subjects to complete each test | Baseline, up to Day 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic Venous Pressure Gradient (HVPG) testing, HepQuant-SHUNT, Liver Function