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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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(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.

Group Type OTHER

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

Intervention Type 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

Hepatic Venous Pressure Gradient (HVPG)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DRUG

Hepatic Venous Pressure Gradient (HVPG)

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

Intervention Type DEVICE

Other Intervention Names

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HQ-SHUNT (HVPG)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No