N/A
N=280
The SHUNT-V Study for Varices
Chronic Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT03583996 ↗Enrolled (actual)
280
Serious AEs
1.7%
Results posted
Apr 2025
Primary outcome: Primary: Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices — 33; 3; 171; 68 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- HepQuant SHUNT Liver Diagnostic Test (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HepQuant, LLC
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Severity Index (DSI) Less Than/Equal to 18.3 to Rule Out Large Varices |
33; 3; 171; 68 | — |
| SECONDARY DSI and Probability of Large Esophageal Varices |
33; 3; 171; 68 | <0.0001 sig |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03583996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.