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

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523196
• Other study ID #: 15-0520
• Secondary ID: UL1TR001082
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: February 23, 2017

Study information

• Verified date: August 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 23, 2017
• Est. primary completion date: February 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

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

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

Locations

Country	Name	City	State
United States	University of Colorado Denver (Leprino Building)	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 H — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	Hours for Test	Number of hours it took for subjects to complete each test	Baseline, up to Day 60