Chronic Liver DiseaseNCT03583996
The SHUNT-V Study for Varices
A study testing HepQuant SHUNT Liver Diagnostic Test in people with Chronic Liver Disease, run by HepQuant, LLC at 26 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- HepQuant SHUNT Liver Diagnostic Test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 26 sitesUnited States
- Study dates
- 23 Jan 2019to 22 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Digestive Disease Associates
Catonsville, Maryland, 21228
Arizona Liver Health
Chandler, Arizona, 85224
Ralph H Johnson Veterans Affairs Medical Center
Charleston, South Carolina, 29401
Peak Gastroenterlogy Associates
Colorado Springs, Colorado, 80907
Southern CA Research Center
Coronado, California, 92118
Methodist Dallas Liver Center
Dallas, Texas, 75203
Baylor, Scott & White
Dallas, Texas, 75246
Nature Coast Clinical Research
Inverness, Florida, 34452
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
Tandem Clinical Research
Marrero, Louisiana, 70072
Lucas Research (Diabetes & Endocrinology Consultants, PC)
Morehead City, North Carolina, 28557
Intermountain Healthcare
Murray, Utah, 84107
Gastroenterology Health Partners, PLLC
New Albany, Indiana, 47150
Bon Secours, Newport News
Newport News, Virginia, 23602
Accel Research Sites
Orange City, Florida, 32763
California Liver Research Institute
Pasadena, California, 91105
Gastroenterology Associates of Pensacola
Pensacola, Florida, 32503
Univ of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
Inland Empire Liver Foundation
Rialto, California, 92377
Bon Secours, Richmond
Richmond, Virginia, 23226
Gastroenterology Consultants of SW VA
Roanoke, Virginia, 24014
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Clinical Trials of Texas
San Antonio, Texas, 78229
University of WA
Seattle, Washington, 98195
St Louis University
St Louis, Missouri, 63104
PMG Research
Winston-Salem, North Carolina, 27103
About this study
Official title: The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study
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.
Read the 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. 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.
- Conditions
- Chronic Liver Disease
- Being tested
- HepQuant SHUNT Liver Diagnostic Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: HepQuant SHUNT Liver Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
DSI and Probability of Large Esophageal Varices
Logistic regression analysis of DSI as predictor of large varices
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start23 Jan 2019
- Primary completion7 May 2021
- Study completion22 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- HepQuant, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Everson, MD, Study director, HepQuant, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583996
- Sponsor's protocol ID
- HQ-US-SHUNT-1801
- Status last verified
- Mar 2025
- First submitted
- 20 Apr 2018
- Last updated
- 11 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rahimi RS, Mena E, Lucas KJ, McRae MP, Kittelson J, Imperial JC, Smith AD, Everson GT; SHUNT-V Subjects, Investigators, and Coordinators. HMG-CoA Reductase Inhibitors (Statins) May Preserve Hepatic Function and Reduce Portal-Systemic Shunting in Compensated Advanced Chronic Liver Disease: Results From the SHUNT-V Study. Clin Transl Gastroenterol. 2026 Mar 1;17(3):e00980. doi: 10.14309/ctg.0000000000000980.
PubMed 41586527Shiffman 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.
PubMed 39523681
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HepQuant SHUNT Liver Diagnostic Kit for Likelihood of Large Esophageal Varices: The SHUNT-V Study
- ClinicalTrials.gov ID
- NCT03583996
- Acronym / sponsor ID
- HQ-US-SHUNT-1801
- Conditions
- Chronic Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- HepQuant, LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 22 Oct 2022 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 11 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Combination Product: HepQuant SHUNT Liver Diagnostic TestAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepQuant SHUNT Liver Diagnostic TestOne 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 | Combination product | Open Label |
Primary outcome
Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices
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.
1 secondary outcome
DSI and Probability of Large Esophageal Varices
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41586527Rahimi RS, Mena E, Lucas KJ, McRae MP, Kittelson J, Imperial JC, Smith AD, Everson GT; SHUNT-V Subjects, Investigators, and Coordinators. HMG-CoA Reductase Inhibitors (Statins) May Preserve Hepatic Function and Reduce Portal-Systemic Shunting in Compensated Advanced Chronic Liver Disease: Results From the SHUNT-V Study. Clin Transl Gastroenterol. 2026 Mar 1;17(3):e00980. doi: 10.14309/ctg.0000000000000980.
- Derived from this study: PubMed 39523681Shiffman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Everson, MD study director
HepQuant, LLC
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HepQuant SHUNT Liver Diagnostic Test in people with Chronic Liver Disease, run by HepQuant, LLC at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03583996, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.