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Completed

NCT Number: NCT02523196

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.

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Key information

Conditions

Liver Disease Digestive System Diseases Liver Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Denver (Leprino Building)

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)

Drug

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

Hepatic Venous Pressure Gradient (HVPG)

Device

Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease

Other names: (HVPG)

Primary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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

  1. Survey Patients on Their Experience of Having Both HQ-SHUNT and HVPG Procedures.

    Time frame: 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

  2. Hours for Test

    Time frame: Baseline, up to Day 60

    Number of hours it took for subjects to complete each test

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 14, 2015
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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