Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
NCT ID: NCT03087968
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2016-07-31
2017-09-13
Brief Summary
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Detailed Description
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This substudy uses the HepQuant SHUNT Liver Diagnostic test to assess severity of disease at baseline and to track disease progression or improvement over the 24 weeks of the study. The HepQuant SHUNT test will be performed at baseline (Day 1) and at Weeks 1, 2, 4, 12, and 24 regardless of treatment Arm.
GS-4997 Dose and Mode of Administration. Subjects will be randomized 1:1 to either:
* Treatment Group A: GS-4997 18 mg (1 x 18 mg tablet) AND prednisolone 40 mg (4 x 10 mg tablets), both administered orally once daily
* Treatment Group B: GS-4997 placebo (1 tablet) AND prednisolone 40 mg (4 x 10 mg tablets), both administered orally once daily
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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GS-4997 + Prednisolone
GS-4997 + Prednisolone for 28 days
HepQuant SHUNT Test
GS-4997
Experimental drug
Prednisolone
Control drug that is also administered with the Experimental drug, GS-4997. This drug is used in both arms.
HepQuant SHUNT Test
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.
Prednisolone + Placebo
Placebo + Prednisolone for 28 days
HepQuant SHUNT Test
Prednisolone
Control drug that is also administered with the Experimental drug, GS-4997. This drug is used in both arms.
HepQuant SHUNT Test
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.
Placebo
Placebo
Interventions
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GS-4997
Experimental drug
Prednisolone
Control drug that is also administered with the Experimental drug, GS-4997. This drug is used in both arms.
HepQuant SHUNT Test
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.
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of severe AH
3. Maddrey's DF ≥ 32 at screening
Exclusion Criteria
2. 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;
3. Serum AST \>400 U/L or ALT \>300 U/L;
4. MELD \>30 at screening;
5. Maddrey's DF \>60 at screening;
6. Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria;
7. Concomitant or previous history of hepatocellular carcinoma;
8. History of liver transplantation;
9. HIV Ab positive;
10. Clinical suspicion of pneumonia;
11. Uncontrolled sepsis;
12. 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;
13. 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;
14. Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation);
15. Portal vein thrombosis;
16. Acute pancreatitis;
18 Years
70 Years
ALL
No
Sponsors
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HepQuant, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Greg Everson, MD
Role: PRINCIPAL_INVESTIGATOR
HepQuant, LLC
Locations
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Southern California Research Center
Coronado, California, United States
University of Miami
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Liver Institute of Virginia
Newport News, Virginia, United States
Liver Institute of Virginia
Richmond, Virginia, United States
VCU Health System
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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HepQuant-002-2124
Identifier Type: -
Identifier Source: org_study_id
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