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- Klinische proef NCT03087968
Evaluation of HepQuant SHUNT to Assess Liver Disease; Substudy Within GS-US-416-2124
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The main study is a Phase 2, double blind, proof-of-concept, randomized study evaluating the safety, tolerability, and biological activity of GS-4997 in combination with prednisolone, compared to prednisolone alone, in subjects with severe, histologically-confirmed AH.
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
Studietype
Fase
- Vroege fase 1
Contacten en locaties
Studie Locaties
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California
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Coronado, California, Verenigde Staten, 92118
- Southern California Research Center
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Florida
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Miami, Florida, Verenigde Staten, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- University of Minnesota
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39216
- University of Mississippi Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania
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Texas
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Dallas, Texas, Verenigde Staten, 75203
- The Liver Institute at Methodist Dallas Medical Center
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San Antonio, Texas, Verenigde Staten, 78215
- American Research Corporation at The Texas Liver Institute
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Utah
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Murray, Utah, Verenigde Staten, 84107
- Intermountain Medical Center
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Virginia
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Newport News, Virginia, Verenigde Staten, 23602
- Liver Institute of Virginia
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Richmond, Virginia, Verenigde Staten, 23226
- Liver Institute of Virginia
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Richmond, Virginia, Verenigde Staten, 23298
- VCU Health System
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Washington
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Seattle, Washington, Verenigde Staten, 98104
- University of Washington
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
Key Exclusion Criteria:
- 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;
- Acute pancreatitis;
- Cessation of alcohol consumption for more than 2 months before Baseline/ Day 1 NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: GS-4997 + Prednisolone
GS-4997 + Prednisolone for 28 days HepQuant SHUNT Test |
Experimental drug
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.
Andere namen:
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Placebo-vergelijker: Prednisolone + Placebo
Placebo + Prednisolone for 28 days HepQuant SHUNT Test |
Placebo
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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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To compare the change in (DSI ) Disease Severity Index between GS-4997 treatment and placebo arms
Tijdsspanne: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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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.
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Secondary Outcome 1
Tijdsspanne: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To determine the relationship of baseline Disease Severity Index (DSI) to mortality risk;
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Secondary Outcome 2
Tijdsspanne: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To determine the relationship of change in Disease Severity Index (DSI) to mortality risk
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Secondary Outcome 3
Tijdsspanne: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To correlate baseline Disease Severity Index (DSI) with baseline Maddrey, MELD, and Lille scorestest with the pharmacokinetics of GS-4997
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Secondary Outcome 4
Tijdsspanne: HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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To determine the relationship between baseline Disease Severity Index (DSI), Maddrey, MELD, and Lille scores and mortality
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HepQuant Shunt testing will be done at baseline (Day1), Week 1, Week 4, Week 12, Week 24
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Greg Everson, MD, HepQuant, LLC
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Chemisch veroorzaakte aandoeningen
- Ziekten van het spijsverteringsstelsel
- Aan alcohol gerelateerde aandoeningen
- Middelgerelateerde aandoeningen
- Hepatitis
- Leverziekten, alcoholisch
- Door alcohol veroorzaakte stoornissen
- Lever Ziekten
- Hepatitis, alcoholist
- Fysiologische effecten van medicijnen
- Ontstekingsremmende middelen
- Antineoplastische middelen
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Prednisolon
Andere studie-ID-nummers
- HepQuant-002-2124
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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