Clinical trial NCT03294941: The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
Official title: The HepQuant SHUNT Test for Monitoring Liver Disease and Treatment Effects by Measuring Liver Function and Physiology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: HepQuant, LLC
Sponsor class: INDUSTRY
First posted: 2017-09-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: All subjects receive HepQuant SHUNT test and DSI measurement, but must first be enrolled into one of the three Gilead clinical trials listed above before they can be enrolled in the HepQuant study. Since the assigned intervention, the HepQuant SHUNT test, is the same for all participants in all three Gilead clinical trials, there is only one arm and intervention for the HepQuant study itself. Some analyses are conducted by grouping subjects into those who took the placebo in the parallel drug study versus those who were on active study drug in the parallel study.
Primary purpose: DIAGNOSTIC

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 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

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-3), and, GS-US-384-1944 trial of NASH and compensated cirrhosis (STELLAR-4). The time points for the HepQuant SHUNT tests coincide with pre-specified time points within the Gilead clinical trials. Subjects enrolled in GILEAD's STELLAR and Alcoholic hepatitis trials may participate concurrently in this HepQuant sponsored investigational device study at participating US sites only (IDEs as listed above) once approved by the applicable IRB/IEC.

The main eligibility criteria for enrollment into the HepQuant study is enrollment into one of the three Gilead clinical trials listed above.

The HepQuant SHUNT Test is minimally-invasive and measures hepatocyte function and inflow to the liver from the simultaneous clearances (hepatic filtration rates, HFRs) of cholate from systemic and portal circulations. The Test quantifies portal-systemic shunting (SHUNT) and generates a liver disease severity index (DSI). DSI is a score from 0 (no disease) to 50 (terminal illness) that is a composite of both HFRs and correlates with stage of fibrosis, presence of varices, especially large varices, and risk for future clinical outcomes. DSI is the primary output variable from the HepQuant SHUNT test. The HepQuant SHUNT test potentially satisfies the unmet medical need for a minimally-invasive test of global liver function and physiology

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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

Primary outcomes:
measure: Baseline DSI
timeFrame: Baseline
measure: Change in DSI From Baseline to 48 Weeks
timeFrame: Baseline and at 48 weeks
Secondary outcomes:
measure: Severity of Liver Disease Index (DSI) Scores Stratified by Baseline NASH CRN Stage of Fibrosis
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: Schiff Center for Liver Diseases
state: Florida
city: Philadelphia
country: United States
facility: University of PA
state: Pennsylvania
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: TX Digestive Disease Consultants
state: Texas
city: San Antonio
country: United States
facility: The Texas Liver Institute
state: Texas
city: Richmond
country: United States
facility: McGuire VA Med Cntr
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washingtion
state: Washington
Study officials:
affiliation: HepQuant, LLC
name: Greg Everson, MD
role: STUDY_DIRECTOR
References: