Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Results of HepQuant SHUNT Test: Systemic Clearance
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
(HVPG) and HepQuant-SHUNT (HQ-Shunt)
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.
Intervention: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate) (Drug)
(HVPG) and HepQuant-SHUNT (HQ-Shunt)
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.
Intervention: Hepatic Venous Pressure Gradient (HVPG) (Device)
Outcomes
Primary Outcomes
Results of HepQuant SHUNT Test: Systemic Clearance
Time Frame: Up to 90 minutes
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)
Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate
Time Frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: DSI Score
Time Frame: Up to 90 minutes
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.
Results of HepQuant SHUNT Test: Apparent Portal Clearance
Time Frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: SHUNT
Time Frame: Up to 90 minutes
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
Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)
Time Frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate
Time Frame: Up to 90 minutes
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG \<6 mmHg) portal hypertension.
Results of HepQuant SHUNT Test: STAT
Time Frame: 60 minutes
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.
Secondary Outcomes
- Hours for Test(Baseline, up to Day 60)
- Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.(Immediately post HepQuant SHUNT test (Baseline up to Day 60))