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

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.

Study Overview

• Status: Completed
• 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)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver (Leprino Building)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: (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.

Drug: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate); 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; Other Names: HQ-SHUNT; Device: Hepatic Venous Pressure Gradient (HVPG); Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease; 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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Amanda Wieland, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Lauriski S, Curto TM, Stoddard A, Wright EC; HALT-C Trial Group. Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial. Hepatology. 2012 Apr;55(4):1019-29. doi: 10.1002/hep.24752. Epub 2012 Mar 1.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): February 23, 2017
• Study Completion (Actual): February 23, 2017

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Liver Function; Hepatic Venous Pressure Gradient (HVPG) testing; HepQuant-SHUNT
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Gastrointestinal Agents; Cholic Acids
• Other Study ID Numbers: 15-0520; UL1TR001082 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No