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The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology

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ClinicalTrials.gov Identifier: NCT03294941
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
HepQuant, LLC

Brief Summary:

The HepQuant SHUNT test, which is provided as a HepQuant SHUNT Liver Diagnostic Kit, is a minimally-invasive test of liver function and physiology which has been designated by the FDA as an investigational drug/device combination product.

Enrollment into one of the 3 Gilead Selonsertib clinical trials (GS-US-416-2124, GS-US-384-1943/1944) is required for enrollment into the HepQuant study


Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Combination Product: HepQuant SHUNT Liver Diagnostic Kit Phase 2

Detailed Description:

The HepQuant study is to run parallel to the Gilead clinical trials,GS-US-416-2124 trial of Alcoholic Hepatitis, GS-US-384-1943 trial of non-alcoholic steatohepatitis (NASH) fibrosis Stage 3 (STELLAR-3), and, GS-US-384-1944 trial of NASH and compensated cirrhosis (STELLAR-4). The time points for the HepQuant SHUNT tests coincide with pre-specified time points within the Gilead clinical trials. Subjects enrolled in GILEAD's STELLAR and Alcoholic hepatitis trials may participate concurrently in this HepQuant sponsored investigational device study at participating US sites only (IDEs as listed above) once approved by the applicable IRB/IEC.

The main eligibility criteria for enrollment into the HepQuant study is enrollment into one of the three Gilead clinical trials listed above.

The HepQuant SHUNT Test is minimally-invasive and measures hepatocyte function and inflow to the liver from the simultaneous clearances (hepatic filtration rates, HFRs) of cholate from systemic and portal circulations. The Test quantifies portal-systemic shunting (SHUNT) and generates a liver disease severity index (DSI). DSI is a score from 0 (no disease) to 50 (terminal illness) that is a composite of both HFRs and correlates with stage of fibrosis, presence of varices, especially large varices, and risk for future clinical outcomes. DSI is the primary output variable from the HepQuant SHUNT test. The HepQuant SHUNT test potentially satisfies the unmet medical need for a minimally-invasive test of global liver function and physiology


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
Actual Study Start Date : December 8, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
HepQuant SHUNT Liver Diagnostic Kit
All subjects receive HepQuant SHUNT test and DSI measurement. 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
Combination Product: HepQuant SHUNT Liver Diagnostic Kit
Serial testing over 48 weeks
Other Name: SHUNT test




Primary Outcome Measures :
  1. Baseline DSI [ Time Frame: Up to 240 weeks ]
    Baseline severity of liver disease

  2. Change in DSI over study period [ Time Frame: Up to 240 weeks ]
    Improvement or worsening of liver disease severity


Secondary Outcome Measures :
  1. Comparing DSI to other tests of liver disease severity [ Time Frame: Up to 240 weeks ]
    Correlation of DSI with other baseline tests of liver disease severity



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The key inclusion criteria for this HepQuant Parallel Study are the inclusion criteria into one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). Once that has been met, subjects must:

  • Be able to ingest liquid by mouth
  • Have venous access to support a peripheral IV and 6 blood draws

Exclusion Criteria:

The key exclusion criteria for this HepQuant Parallel Study are the exclusion criteria for one of the Gilead selonsertib trials (GS-US-416-2124, GS-US-384-1943 or 1944). If this has been met, the subject is not eligible to participate in HepQuant. If no exclusion criteria has been met for the Gilead selonsertib trial, ADDITIONAL exclusions for HepQuant are:

  • Subject should not have had first dose of selonsertib
  • Subject cannot take anything by mouth
  • Subject cannot be hypersensitive to eggs, albumin preparations, any ingredient in the formulation, or component of the container
  • Subject cannot have intercurrent medical or surgical illness (eg: acute MI, acute cerebral hemorrhage, sepsis)
  • subject cannot have had extensive resection of large segments of small intestine (short gut)
  • Subject cannot have severe gastroparesis

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): NCT03294941


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

Locations
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United States, Florida
Schiff Center for Liver Diseases Recruiting
Miami, Florida, United States, 33136
Contact: Kay Sornmayura, RN    305-243-6681    ksornmayura@med.miami.edu   
Principal Investigator: Kaylan Bhamidimarri, MD         
United States, Pennsylvania
University of PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christine Gepty    215-349-8563    christine.gepty@uphs.upenn.edu   
Principal Investigator: Rajender Reddy, MD         
United States, Texas
Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: LaToya Thomas    214-947-1288    latoyathomas@mhd.com   
Principal Investigator: Parvez Mantry, MD         
Principal Investigator: Mangesh Pagadala, MD         
TX Digestive Disease Consultants Recruiting
Dallas, Texas, United States, 76092
Contact: Anne Marie Jones    214-820-1710    anne.jones@bswhealth.org   
Principal Investigator: James Trotter, MD         
The Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Contact: Bertha Buan    210-253-3426    bbuan@txliver.com   
Contact: Toluwalase Okubote    210-253-3426    tokubote@txliver.com   
Principal Investigator: Naim Alkhouri, MD         
Principal Investigator: Fred Poordad, MD         
United States, Virginia
McGuire VA Med Cntr Recruiting
Richmond, Virginia, United States, 23224
Contact: Jill Meador    804-675-6407    jill.meador@va.gov   
Principal Investigator: Michael Fuchs, MD         
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Leslie Yost Schomer    804-828-6314    leslie.yostschomer@vcuhealth.org   
Principal Investigator: Arun Sanyul, MD         
United States, Washington
University of Washingtion Recruiting
Seattle, Washington, United States, 98103
Contact: Jenna Craft    206-543-0826    jcraft@medicine.washington.edu   
Principal Investigator: Kiran Bambha, MD         
Sponsors and Collaborators
HepQuant, LLC

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Responsible Party: HepQuant, LLC
ClinicalTrials.gov Identifier: NCT03294941     History of Changes
Other Study ID Numbers: HQ-US-SHUNT-1701
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Liver Extracts
Hematinics