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

Phase 3

Completed

Conditions: Liver Disease

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

Registration Number: NCT02523196

Lead Sponsor: University of Colorado, Denver

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(HVPG) and HepQuant-SHUNT (HQ-Shunt)	HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)	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.
(HVPG) and HepQuant-SHUNT (HQ-Shunt)	Hepatic Venous Pressure Gradient (HVPG)	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.

Primary Outcome Measures

Name	Time	Method
Results of HepQuant SHUNT Test: Systemic Clearance	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	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	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	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	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)	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	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	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 Outcome Measures

Name	Time	Method
Hours for Test	Baseline, up to Day 60	Number of hours it took for subjects to complete each test
Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.	Immediately post HepQuant SHUNT test (Baseline up to Day 60)	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