Status:
TERMINATED
The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
Lead Sponsor:
HepQuant, LLC
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 investigat...
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03294941
Start Date
December 8 2017
End Date
September 11 2019
Last Update
August 9 2021
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Schiff Center for Liver Diseases
Miami, Florida, United States, 33136
2
University of PA
Philadelphia, Pennsylvania, United States, 19104
3
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
4
TX Digestive Disease Consultants
Dallas, Texas, United States, 76092