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

Primary Purpose

Liver Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)
Hepatic Venous Pressure Gradient (HVPG)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Disease focused on measuring Hepatic Venous Pressure Gradient (HVPG) testing, HepQuant-SHUNT, Liver Function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Denver (Leprino Building)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

(HVPG) and HepQuant-SHUNT (HQ-Shunt)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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)
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.
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.
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.
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
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.
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.

Secondary Outcome Measures

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
Hours for Test
Number of hours it took for subjects to complete each test

Full Information

First Posted
August 3, 2015
Last Updated
August 5, 2021
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT02523196
Brief Title
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Official Title
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 23, 2017 (Actual)
Study Completion Date
February 23, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
Hepatic Venous Pressure Gradient (HVPG) testing, HepQuant-SHUNT, Liver Function

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(HVPG) and HepQuant-SHUNT (HQ-Shunt)
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)
Other Intervention Name(s)
HQ-SHUNT
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Hepatic Venous Pressure Gradient (HVPG)
Other Intervention Name(s)
(HVPG)
Intervention Description
Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease
Primary Outcome Measure Information:
Title
Results of HepQuant SHUNT Test: Elimination Rate (IV Phase 1 Only; Min-1)
Description
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Time Frame
Up to 90 minutes
Title
Results of HepQuant SHUNT Test: Systemic Clearance
Description
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)
Time Frame
Up to 90 minutes
Title
Results of HepQuant SHUNT Test: Apparent Portal Clearance
Description
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Time Frame
Up to 90 minutes
Title
Results of HepQuant SHUNT Test: Systemic Hepatic Filtration Rate
Description
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Time Frame
Up to 90 minutes
Title
Results of HepQuant SHUNT Test: Portal Hepatic Filtration Rate
Description
Compare Disease Severity Index (DSI) from HQ-SHUNT for defining patients with (HVPG ≥6 mmHg) and without (HVPG <6 mmHg) portal hypertension.
Time Frame
Up to 90 minutes
Title
Results of HepQuant SHUNT Test: SHUNT
Description
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
Time Frame
Up to 90 minutes
Title
Results of HepQuant SHUNT Test: DSI Score
Description
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.
Time Frame
Up to 90 minutes
Title
Results of HepQuant SHUNT Test: STAT
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.
Description
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
Time Frame
Immediately post HepQuant SHUNT test (Baseline up to Day 60)
Title
Hours for Test
Description
Number of hours it took for subjects to complete each test
Time Frame
Baseline, up to Day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Wieland, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver (Leprino Building)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22030902
Citation
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.
Results Reference
result

Learn more about this trial

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

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