Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)
NCT ID: NCT02854631
Last Updated: 2019-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2016-09-01
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Selonsertib + Prednisolone
Selonsertib + prednisolone for 28 days
Selonsertib
18 mg tablet administered orally once daily
Prednisolone
40 mg (4 x 10 mg tablets) administered orally once daily
Prednisolone
Selonsertib placebo + prednisolone for 28 days
Prednisolone
40 mg (4 x 10 mg tablets) administered orally once daily
Placebo
Selonsertib placebo tablet administered orally once daily
Interventions
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Selonsertib
18 mg tablet administered orally once daily
Prednisolone
40 mg (4 x 10 mg tablets) administered orally once daily
Placebo
Selonsertib placebo tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of severe AH
* Maddrey's Discriminant Function (DF) ≥ 32 at screening
Exclusion Criteria
* 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 aspartate aminotransferase (AST) \>400 U/L or alanine aminotransferase (ALT) \>300 U/L;
* Model for End Stage Liver Disease (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
18 Years
70 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Research Centers
Coronado, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Cleveland Clinic Florida
Weston, Florida, United States
Oschner Medical Center
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Methodist Healthcare Dallas - The Liver Institute
Dallas, Texas, United States
Liver Institute of Virginia
Newport News, Virginia, United States
University of Washington
Seattle, Washington, United States
Medizinische Universitat Graz
Graz, , Austria
Universitätsklinik für Innere Medizin I
Innsbruck, , Austria
Medical University Vienna
Vienna, , Austria
Cliniques Universitaires UCL Saint-Luc
Brussels, , Belgium
CUB Hopital Erasme
Brussels, , Belgium
Ghent University Hospital
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege
Liège, , Belgium
University of Calgary
Calgary, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Toronto General Hospital
Toronto, Ontario, Canada
CHU Amiens Picardie
Amiens, , France
CHU Angers
Angers, , France
Hôpital Jean Minjoz
Besançon, , France
C.H.U. de Caen
Caen, , France
CHU henri Mondor
Créteil, , France
CHU de Grenoble- Hopital Michallon
La Tronche, , France
CHRU de Lille
Lille, , France
Hôpital de la Croix Rousse
Lyon, , France
Hopital La Pitie Salpetriere
Paris, , France
Hopital Paul Brousse
Villejuif, , France
University of Zurich
Zurich, , Switzerland
Brighton & Sussex University Hospitals NHS Trust
Brighton, , United Kingdom
Hull and East Yorkshire Hospitals NHS Trust
Hull, , United Kingdom
Royal Liverpool & Broadgreen University Hospitals NHS Trust
Liverpool, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Imperial College
London, , United Kingdom
Kings College Hospital NHS Trust
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000821-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-416-2124
Identifier Type: -
Identifier Source: org_study_id
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