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

NCT03294941 | Terminated Phase 2 Results FDA Drug FDA Device

• 1 other identifier: HQ-US-SHUNT-1701
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 8

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

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• Baseline DSI

  The baseline DSI, or disease severity index, is a measure of severity of liver disease at baseline. The scores for DSI range on a scale from 0 (healthy liver) to 50 (severe liver disease).

  Baseline

• Change in DSI From Baseline to 48 Weeks

  Improvement or worsening of liver disease severity from baseline to the week 48 visit as measured by the change in the disease severity index (DSI) (DSI at 48 weeks minus DSI at baseline). The scores for DSI range on a scale from 0 (healthy liver) to 50 (severe liver disease).

  Baseline and at 48 weeks

Secondary Outcomes (1)

• Severity of Liver Disease Index (DSI) Scores Stratified by Baseline NASH CRN Stage of Fibrosis

  Baseline

Study Arms (1)

HepQuant SHUNT Liver Diagnostic Kit

OTHER

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

Combination Product: HepQuant SHUNT Liver Diagnostic Kit

Interventions

HepQuant SHUNT Liver Diagnostic Kit COMBINATION_PRODUCT

Serial testing over 48 weeks

Also known as: SHUNT test

HepQuant SHUNT Liver Diagnostic Kit

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to ingest liquid by mouth
• Have venous access to support a peripheral IV and 6 blood draws

You may not qualify if:

• 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

Sponsors & Collaborators

• HepQuant, LLC: lead

Study Sites (8)

Schiff Center for Liver Diseases

Miami, Florida, 33136, United States

Location

University of PA

Philadelphia, Pennsylvania, 19104, United States

Location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

TX Digestive Disease Consultants

Dallas, Texas, 76092, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

McGuire VA Med Cntr

Richmond, Virginia, 23224, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washingtion

Seattle, Washington, 98103, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Elyse Handley
• Organization: HepQuant, LLC

elyse.handley@hepquant.com

303-923-2109

Study Officials

• Greg Everson, MD

  HepQuant, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: September 27, 2017
• Study Start: December 8, 2017
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: August 9, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-08

Locations

US (8)