drugset / Trial / NCT03583996

The SHUNT-V Study for Varices

NCT03583996 ↗

Completed 306 enrolled HepQuant, LLC
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2019-01-23
Primary completion
2021-05-07
Completion
2022-10-22

Outcome

Met primary endpoint

paper DSI 18.3 had sensitivity 96.3%-100% for LEV and 97.3%-100% for all significant PH lesions. PMID 39523681 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 13C Cholate Unknown 20 mg —
Subject d4 Cholate Unknown 40 mg —

Indications