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The SHUNT-V Study for Varices

Primary Purpose

Chronic Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HepQuant SHUNT Liver Diagnostic Test
Sponsored by
HepQuant, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to have a peripheral venous catheter for administration of the 13C cholate
  • Ability to take the oral dose of d4-cholate
  • Ability to hold morning doses of medications for the 90-minute duration of the HepQuant SHUNT Test
  • Meets the protocol defined criteria for CLD in addition to having the diagnoses of CLD for >6 months
  • Is scheduled, or in the process of being scheduled, for a standard of care EGD

Exclusion Criteria:

  • Unable to give informed consent
  • Unable to obtain venous access for administration of intravenous cholate
  • Unable to absorb orally-administered cholate
  • Known hypersensitivity to human serum albumin
  • Known hypersensitivity to any of the components of the HepQuant SHUNT Liver Diagnostic Kit
  • Acute hepatitis or Acute Liver Failure
  • Acute drug-induced liver disease (DILI)
  • Noncirrhotic causes for portal hypertension and varices
  • Ongoing active alcoholic hepatitis
  • Child-Pugh class C defined by Child-Pugh score 10 or higher
  • Dialysis
  • Active infection or febrile illness within the last month
  • Documented history of esophageal or gastric variceal hemorrhage
  • Documented history of treatment of esophageal varices
  • Documented history of endoscopic findings of large esophageal varices
  • Hepatocellular carcinoma beyond Milan or UCSF criteria
  • Thrombosis of main portal vein
  • Liver transplant recipient
  • Pregnancy
  • Women who are breast-feeding
  • Serious intercurrent medical or surgical illness, such as acute myocardial infarction, acute cerebral hemorrhage, sepsis, or other immediate life-threatening illness

Sites / Locations

  • Arizona Liver Health
  • Southern CA Research Center
  • California Liver Research Institute
  • Inland Empire Liver Foundation
  • Peak Gastroenterlogy Associates
  • Nature Coast Clinical Research
  • Mayo Clinic, Jacksonville
  • Accel Research Sites
  • Gastroenterology Associates of Pensacola
  • Gastroenterology Health Partners, PLLC
  • Tandem Clinical Research
  • Digestive Disease Associates
  • Mayo Clinic, Rochester
  • St Louis University
  • Lucas Research (Diabetes & Endocrinology Consultants, PC)
  • PMG Research
  • Univ of Pennsylvania Hospital
  • Ralph H Johnson Veterans Affairs Medical Center
  • Methodist Dallas Liver Center
  • Baylor, Scott & White
  • Clinical Trials of Texas
  • Intermountain Healthcare
  • Bon Secours, Newport News
  • Bon Secours, Richmond
  • Gastroenterology Consultants of SW VA
  • University of WA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label

Arm Description

All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.

Outcomes

Primary Outcome Measures

DSI less than/equal to 18.3
The primary objective of this study is to measure the subjects' liver function using DSI ≤18.3 for those that are not likely to have large esophageal varices.

Secondary Outcome Measures

DSI greater than 18.3
Secondary objective is to measure the subjects' liver function using DSI >18.3 for those subjects who are likely to have large esophageal varices.

Full Information

First Posted
April 20, 2018
Last Updated
August 27, 2021
Sponsor
HepQuant, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03583996
Brief Title
The SHUNT-V Study for Varices
Official Title
The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
May 7, 2021 (Actual)
Study Completion Date
May 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HepQuant, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.
Detailed Description
The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices. Our HALT-C Training dataset demonstrated that the DSI 18.3 had sensitivity 95%, specificity 54%, PPV 19%, NPV >99%, negative likelihood ratio (NLR) 0.09, and positive likelihood ratio (PLR) 2.09 for large varices. To validate DSI 18.3 as a cutoff for large varices, we will enroll 420 subjects with chronic liver disease (CLD) of mixed etiologies from 15 to 25 US clinical centers (CLD Validation dataset). The target prevalence of large varices is ≥20%. Each subject will have been scheduled for an esophago-gastro-duodenoscopy (EGD) as part of their standard of care for either variceal or non-variceal indications. Enrolled subjects will undergo standard clinical assessment, laboratory tests, and the HepQuant SHUNT Test. The EGD will be performed within 6 weeks following the HepQuant SHUNT Test. The relationship of DSI to large varices will be analyzed by univariate and multivariate logistic regression analyses, AUROC, and linear and nonlinear regression and correlation coefficients. Diagnostic performance of the DSI cutoff will be defined in the CLD Validation dataset and validated for likelihood of large esophageal varices. The validated DSI cutoff will identify subjects who are either unlikely or likely to have large esophageal varices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects receive HepQuant SHUNT test and DSI measurement prior to a SOC EGD, to be done within 42 days of the SHUNT test. HepQuant SHUNT is a combination product where 13C Cholate 20mg is administered intravenously once for each test and d4 Cholate 40mg is administered once orally for each test
Masking
None (Open Label)
Allocation
N/A
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label
Arm Type
Experimental
Arm Description
All subjects receive HepQuant SHUNT Liver Diagnostic Test within 42 days of the scheduled EGD. Test includes 20mg of 13C Cholate mixed with Albumin via IV push, and 40mg of d4 Cholate mixed with juice orally, both doses given simultaneously one time.
Intervention Type
Combination Product
Intervention Name(s)
HepQuant SHUNT Liver Diagnostic Test
Intervention Description
One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test will be completed prior to the EGD. Each subject will receive an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate
Primary Outcome Measure Information:
Title
DSI less than/equal to 18.3
Description
The primary objective of this study is to measure the subjects' liver function using DSI ≤18.3 for those that are not likely to have large esophageal varices.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
DSI greater than 18.3
Description
Secondary objective is to measure the subjects' liver function using DSI >18.3 for those subjects who are likely to have large esophageal varices.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to have a peripheral venous catheter for administration of the 13C cholate Ability to take the oral dose of d4-cholate Ability to hold morning doses of medications for the 90-minute duration of the HepQuant SHUNT Test Meets the protocol defined criteria for CLD in addition to having the diagnoses of CLD for >6 months Is scheduled, or in the process of being scheduled, for a standard of care EGD Exclusion Criteria: Unable to give informed consent Unable to obtain venous access for administration of intravenous cholate Unable to absorb orally-administered cholate Known hypersensitivity to human serum albumin Known hypersensitivity to any of the components of the HepQuant SHUNT Liver Diagnostic Kit Acute hepatitis or Acute Liver Failure Acute drug-induced liver disease (DILI) Noncirrhotic causes for portal hypertension and varices Ongoing active alcoholic hepatitis Child-Pugh class C defined by Child-Pugh score 10 or higher Dialysis Active infection or febrile illness within the last month Documented history of esophageal or gastric variceal hemorrhage Documented history of treatment of esophageal varices Documented history of endoscopic findings of large esophageal varices Hepatocellular carcinoma beyond Milan or UCSF criteria Thrombosis of main portal vein Liver transplant recipient Pregnancy Women who are breast-feeding Serious intercurrent medical or surgical illness, such as acute myocardial infarction, acute cerebral hemorrhage, sepsis, or other immediate life-threatening illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Everson, MD
Organizational Affiliation
HepQuant, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Southern CA Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Peak Gastroenterlogy Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Accel Research Sites
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Gastroenterology Associates of Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Gastroenterology Health Partners, PLLC
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Digestive Disease Associates
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Mayo Clinic, Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Lucas Research (Diabetes & Endocrinology Consultants, PC)
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
PMG Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Univ of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Ralph H Johnson Veterans Affairs Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Methodist Dallas Liver Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Baylor, Scott & White
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Clinical Trials of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Intermountain Healthcare
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Bon Secours, Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Bon Secours, Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Gastroenterology Consultants of SW VA
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
University of WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The SHUNT-V Study for Varices

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