The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology

Stopped early · Phase 2 · Has a placebo group

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

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

Key facts

Study ID

NCT03294941

Run by

HepQuant, LLC

People needed

17

Starts

2017-12-08

Expected to finish

2019-09-11

Last updated by the study team

2021-08-09

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Schiff Center for Liver Diseases — Miami, Florida, United States
• University of PA — Philadelphia, Pennsylvania, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• TX Digestive Disease Consultants — Dallas, Texas, United States
• The Texas Liver Institute — San Antonio, Texas, United States
• McGuire VA Med Cntr — Richmond, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washingtion — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.