The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
Status: Terminated
Location: See all (8) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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⁃ 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
Locations
United States
Florida
Schiff Center for Liver Diseases
Miami
Pennsylvania
University of PA
Philadelphia
Texas
Methodist Dallas Medical Center
Dallas
TX Digestive Disease Consultants
Dallas
The Texas Liver Institute
San Antonio
Virginia
McGuire VA Med Cntr
Richmond
Virginia Commonwealth University
Richmond
Washington
University of Washingtion
Seattle
Time Frame
Start Date: 2017-12-08
Completion Date: 2019-09-11
Participants
Target number of participants: 17
Treatments
Other: 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
Authors
Related Therapeutic Areas
Sponsors
Leads: HepQuant, LLC