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Trial record 1 of 1 for:    The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study
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The SHUNT-V Study for Varices

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ClinicalTrials.gov Identifier: NCT03583996
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
HepQuant, LLC

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
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 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 : January 23, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

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




Primary Outcome Measures :
  1. DSI less than/equal to 18.3 [ Time Frame: 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 :
  1. DSI greater than 18.3 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583996


Contacts
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Contact: Andrea Herman, RN, BA 303-923-2210 andrea.herman@hepquant.com
Contact: Steve Helmke, PhD 720-651-4493 steve.helmke@hepquant.com

Locations
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United States, Florida
Nature Coast Clinical Research Recruiting
Inverness, Florida, United States, 34452
Contact: Linda Gray    352-341-2100    lgray@encoredocs.com   
Principal Investigator: Paul Hellstern, MD         
Sponsors and Collaborators
HepQuant, LLC
Investigators
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Study Director: Greg Everson, MD HepQuant, LLC

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Responsible Party: HepQuant, LLC
ClinicalTrials.gov Identifier: NCT03583996     History of Changes
Other Study ID Numbers: HQ-US-SHUNT-1801
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases