The SHUNT-V Study for Varices

Sponsor

HepQuant, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT03583996

Collaborator

(none)

311

Enrollment

Locations

Arm

27.4

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Liver Disease	Combination Product: HepQuant SHUNT Liver Diagnostic Test	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

311 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention 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 testAll 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)

Primary Purpose:

Diagnostic

Official Title:

The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study

Actual Study Start Date :

Jan 23, 2019

Actual Primary Completion Date :

May 7, 2021

Actual Study Completion Date :

May 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Label 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.	Combination Product: HepQuant SHUNT Liver Diagnostic Test 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

Arm

Intervention/Treatment

Experimental: Open Label

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.

Combination Product: HepQuant SHUNT Liver Diagnostic Test

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

Outcome Measures

Primary Outcome Measures

DSI less than/equal to 18.3 [1 day]
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 [1 day]
Secondary objective is to measure the subjects' liver function using DSI >18.3 for those subjects who are likely to have large esophageal varices.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Liver Health	Chandler	Arizona	United States	85224
2	Southern CA Research Center	Coronado	California	United States	92118
3	California Liver Research Institute	Pasadena	California	United States	91105
4	Inland Empire Liver Foundation	Rialto	California	United States	92377
5	Peak Gastroenterlogy Associates	Colorado Springs	Colorado	United States	80907
6	Nature Coast Clinical Research	Inverness	Florida	United States	34452
7	Mayo Clinic, Jacksonville	Jacksonville	Florida	United States	32224
8	Accel Research Sites	Orange City	Florida	United States	32763
9	Gastroenterology Associates of Pensacola	Pensacola	Florida	United States	32503
10	Gastroenterology Health Partners, PLLC	New Albany	Indiana	United States	47150
11	Tandem Clinical Research	Marrero	Louisiana	United States	70072
12	Digestive Disease Associates	Catonsville	Maryland	United States	21228
13	Mayo Clinic, Rochester	Rochester	Minnesota	United States	55905
14	St Louis University	Saint Louis	Missouri	United States	63104
15	Lucas Research (Diabetes & Endocrinology Consultants, PC)	Morehead City	North Carolina	United States	28557
16	PMG Research	Winston-Salem	North Carolina	United States	27103
17	Univ of Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19104
18	Ralph H Johnson Veterans Affairs Medical Center	Charleston	South Carolina	United States	29401
19	Methodist Dallas Liver Center	Dallas	Texas	United States	75203
20	Baylor, Scott & White	Dallas	Texas	United States	75246
21	Clinical Trials of Texas	San Antonio	Texas	United States	78229
22	Intermountain Healthcare	Murray	Utah	United States	84107
23	Bon Secours, Newport News	Newport News	Virginia	United States	23602
24	Bon Secours, Richmond	Richmond	Virginia	United States	23226
25	Gastroenterology Consultants of SW VA	Roanoke	Virginia	United States	24014
26	University of WA	Seattle	Washington	United States	98195

Sponsors and Collaborators

HepQuant, LLC

Investigators

Study Director: Greg Everson, MD, HepQuant, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HepQuant, LLC

ClinicalTrials.gov Identifier:

NCT03583996

Other Study ID Numbers:

HQ-US-SHUNT-1801

First Posted:

Jul 12, 2018

Last Update Posted:

Aug 30, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Liver Diseases

Study Results

No Results Posted as of Aug 30, 2021