Study Stopped
No longer a sub-study - Changing to an independent parallel study
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
1 other identifier
interventional
N/A
1 country
13
Brief Summary
This clinical investigation is a substudy within GS-US-416-2124, IND 129570, which is A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination with Prednisolone versus Prednisolone Alone in Subjects with Severe Alcoholic Hepatitis. The use of the HepQuant SHUNT test is to assess liver disease severity before, during, and after treatment with GS-4997 or placebo, to assess liver disease severity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2016
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2016
CompletedFirst Submitted
Initial submission to the registry
March 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2017
CompletedAugust 30, 2021
September 1, 2017
1.1 years
March 9, 2017
August 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
To compare the change in (DSI ) Disease Severity Index between GS-4997 treatment and placebo arms
Using the SHUNT DSI to evaluate the liver, this outcome will compare the two arms to determine if SHUNT DSI is able to measure a change between the experimental and control groups.
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
Secondary Outcomes (4)
Secondary Outcome 1
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
Secondary Outcome 2
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
Secondary Outcome 3
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
Secondary Outcome 4
HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
Study Arms (2)
GS-4997 + Prednisolone
EXPERIMENTALGS-4997 + Prednisolone for 28 days HepQuant SHUNT Test
Prednisolone + Placebo
PLACEBO COMPARATORPlacebo + Prednisolone for 28 days HepQuant SHUNT Test
Interventions
Control drug that is also administered with the Experimental drug, GS-4997. This drug is used in both arms.
The HepQuant SHUNT Liver Diagnostic Kit is intended for use in the quantitative detection of 13C-cholate and d4-cholate in blood serum, collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. The device is indicated to assess the severity of liver disease. For use by health care professionals. Administer the test under a physician's supervision. The HepQuant Analytical Testing Laboratory must analyze the serum samples.
Eligibility Criteria
You may qualify if:
- Willing and able to give informed consent prior to any study specific procedures being performed. In individuals with hepatic encephalopathy (HE) which may impair decision-making, consent will be obtained per hospital procedures (eg, by Legally Authorized Representative)
- Clinical diagnosis of severe AH
- Maddrey's DF ≥ 32 at screening
You may not qualify if:
- Pregnant or lactating females;
- Other causes of liver disease including chronic hepatitis B (hepatitis B surface antigen \[HBsAg\] positive), chronic hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, and autoimmune liver disease;
- Serum AST \>400 U/L or ALT \>300 U/L;
- MELD \>30 at screening;
- Maddrey's DF \>60 at screening;
- Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;
- Concomitant or previous history of hepatocellular carcinoma;
- History of liver transplantation;
- HIV Ab positive;
- Clinical suspicion of pneumonia;
- Uncontrolled sepsis;
- Uncontrolled gastrointestinal (GI) bleeding or controlled GI bleeding within 7 days of screening that was associated with shock or required transfusion of more than 3 units of blood;
- Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine \>221 μmol/L (\>2.5 mg/dL) or the requirement for renal replacement therapy;
- Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation);
- Portal vein thrombosis;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HepQuant, LLClead
Study Sites (13)
Southern California Research Center
Coronado, California, 92118, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Liver Institute of Virginia
Newport News, Virginia, 23602, United States
Liver Institute of Virginia
Richmond, Virginia, 23226, United States
VCU Health System
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Greg Everson, MD
HepQuant, LLC
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2017
First Posted
March 23, 2017
Study Start
July 31, 2016
Primary Completion
September 13, 2017
Study Completion
September 13, 2017
Last Updated
August 30, 2021
Record last verified: 2017-09