NCT02523196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
4 years until next milestone

Results Posted

Study results publicly available

February 5, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

August 3, 2015

Results QC Date

February 3, 2020

Last Update Submit

August 5, 2021

Conditions

Liver Disease

Keywords

Hepatic Venous Pressure Gradient (HVPG) testingHepQuant-SHUNTLiver Function

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

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

    Immediately post HepQuant SHUNT test (Baseline up to Day 60)

  • Hours for Test

    Baseline, up to Day 60

Study Arms (1)

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

OTHER

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.

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

Interventions

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

Also known as: HQ-SHUNT
(HVPG) and HepQuant-SHUNT (HQ-Shunt)
Hepatic Venous Pressure Gradient (HVPG)DEVICE

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

Also known as: (HVPG)
(HVPG) and HepQuant-SHUNT (HQ-Shunt)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver (Leprino Building)

Aurora, Colorado, 80045, United States

Location

Related 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 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.

    PMID: 22030902RESULT

MeSH Terms

Conditions

Liver Diseases

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Digestive System Diseases

Limitations and Caveats

Study did not reach enrollment goal of 110, therefore analysis was limited due to low power

Results Point of Contact

Title
Dr. Amanda Wieland
Organization
University of Colorado Denver
amanda.wieland@cuanschutz.edu
720-848-2291

Study Officials

  • Amanda Wieland, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 14, 2015

Study Start

March 1, 2016

Primary Completion

February 23, 2017

Study Completion

February 23, 2017

Last Updated

August 9, 2021

Results First Posted

February 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)