The SHUNT-V Study for Varices

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583996
• Other study ID #: HQ-US-SHUNT-1801
• Status: Completed
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: May 7, 2021

Study information

• Verified date: August 2021
• Source: HepQuant, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	Digestive Disease Associates	Catonsville	Maryland
United States	Arizona Liver Health	Chandler	Arizona
United States	Ralph H Johnson Veterans Affairs Medical Center	Charleston	South Carolina
United States	Peak Gastroenterlogy Associates	Colorado Springs	Colorado
United States	Southern CA Research Center	Coronado	California
United States	Baylor, Scott & White	Dallas	Texas
United States	Methodist Dallas Liver Center	Dallas	Texas
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Mayo Clinic, Jacksonville	Jacksonville	Florida
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Lucas Research (Diabetes & Endocrinology Consultants, PC)	Morehead City	North Carolina
United States	Intermountain Healthcare	Murray	Utah
United States	Gastroenterology Health Partners, PLLC	New Albany	Indiana
United States	Bon Secours, Newport News	Newport News	Virginia
United States	Accel Research Sites	Orange City	Florida
United States	California Liver Research Institute	Pasadena	California
United States	Gastroenterology Associates of Pensacola	Pensacola	Florida
United States	Univ of Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Inland Empire Liver Foundation	Rialto	California
United States	Bon Secours, Richmond	Richmond	Virginia
United States	Gastroenterology Consultants of SW VA	Roanoke	Virginia
United States	Mayo Clinic, Rochester	Rochester	Minnesota
United States	St Louis University	Saint Louis	Missouri
United States	Clinical Trials of Texas	San Antonio	Texas
United States	University of WA	Seattle	Washington
United States	PMG Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
HepQuant, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day
Secondary	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.	1 day