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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 3

Conditions: Liver Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02523196

15-0520

UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Other group

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.

Treatment:

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

Device: Hepatic Venous Pressure Gradient (HVPG)