The SHUNT-V Study for Varices

HepQuant, LLC306 enrolled

Overview

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.

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. The Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial training dataset demonstrated that the DSI 18.3 had sensitivity 95%, specificity 54%, positive predictive value (PPV) 19%, negative predictive value (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, area under the receiver operating characteristic curve (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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

306

Conditions

Chronic Liver Disease

Interventions

HepQuant SHUNT Liver Diagnostic TestCOMBINATION_PRODUCT

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 University of California, San Francisco (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

Locations (26)

Outcomes

Primary Outcomes

Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices

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 Outcomes

DSI and Probability of Large Esophageal Varices

Logistic regression analysis of DSI as predictor of large varices

Time frame: 1 day

Data from ClinicalTrials.gov

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