NCT03583996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 23, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2022

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 11, 2025

Completed
Last Updated

April 11, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

April 20, 2018

Results QC Date

May 2, 2023

Last Update Submit

March 26, 2025

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (1)

  • DSI and Probability of Large Esophageal Varices

    1 day

Study Arms (1)

Open Label

EXPERIMENTAL

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

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

Open Label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Arizona Liver Health

Chandler, Arizona, 85224, United States

Location

Southern CA Research Center

Coronado, California, 92118, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Peak Gastroenterlogy Associates

Colorado Springs, Colorado, 80907, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

Accel Research Sites

Orange City, Florida, 32763, United States

Location

Gastroenterology Associates of Pensacola

Pensacola, Florida, 32503, United States

Location

Gastroenterology Health Partners, PLLC

New Albany, Indiana, 47150, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Digestive Disease Associates

Catonsville, Maryland, 21228, United States

Location

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

St Louis University

St Louis, Missouri, 63104, United States

Location

Lucas Research (Diabetes & Endocrinology Consultants, PC)

Morehead City, North Carolina, 28557, United States

Location

PMG Research

Winston-Salem, North Carolina, 27103, United States

Location

Univ of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

Ralph H Johnson Veterans Affairs Medical Center

Charleston, South Carolina, 29401, United States

Location

Methodist Dallas Liver Center

Dallas, Texas, 75203, United States

Location

Baylor, Scott & White

Dallas, Texas, 75246, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

Bon Secours, Newport News

Newport News, Virginia, 23602, United States

Location

Bon Secours, Richmond

Richmond, Virginia, 23226, United States

Location

Gastroenterology Consultants of SW VA

Roanoke, Virginia, 24014, United States

Location

University of WA

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Shiffman M, Reddy KR, Leise MD, Qureshi K, Smith AD, Helmke S, Kittelson J, McRae MP, Imperial JC, Everson GT; SHUNT-V Investigators. Cholate Shunt, Oral Cholate Challenge and Endoscopic Lesions of Portal Hypertension: The SHUNT-V Study. Aliment Pharmacol Ther. 2025 Jan;61(1):75-87. doi: 10.1111/apt.18386. Epub 2024 Nov 10.

    PMID: 39523681DERIVED

Results Point of Contact

Title
Elyse Handley
Organization
HepQuant LLC
elyse.handley@hepquant.com
3037480524

Study Officials

  • Greg Everson, MD

    HepQuant, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All subjects receive HepQuant SHUNT test and DSI measurement prior to a standard of care (SOC) EGD, to be done within 42 days of the SHUNT test. HepQuant SHUNT is a combination product where 24-13C-cholic acid (13C cholate) 20mg is administered intravenously once for each test and 2,2,4,4-D4-cholic acid (d4 cholate) 40mg is administered once orally for each test
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2018

First Posted

July 12, 2018

Study Start

January 23, 2019

Primary Completion

May 7, 2021

Study Completion

October 22, 2022

Last Updated

April 11, 2025

Results First Posted

April 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(26)