Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
NCT ID: NCT02854605
Last Updated: 2019-01-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
140 participants
INTERVENTIONAL
2016-10-26
2018-01-09
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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GS-9674 30 mg
GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
GS-9674
Tablet administered orally once daily
Placebo to match GS-9674
Tablet(s) administered orally once daily
GS-9674 100 mg
GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
GS-9674
Tablet administered orally once daily
Placebo to match GS-9674
Tablet(s) administered orally once daily
Placebo
Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
Placebo to match GS-9674
Tablet(s) administered orally once daily
Interventions
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GS-9674
Tablet administered orally once daily
Placebo to match GS-9674
Tablet(s) administered orally once daily
Eligibility Criteria
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Inclusion Criteria
* A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)
* Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF) with ≥ 8% steatosis
* Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5 kilopascal (kPa) OR
* A historical liver biopsy within 12 months of screening consistent with NASH with fibrosis, but not cirrhosis, and
* No documented weight loss \> 5% between the date of the liver biopsy and screening.
* Platelet count ≥ 150,000/mm\^3
* Albumin ≥ 3.3 g/dL
* Serum creatinine ≤ upper limit of normal (ULN)
Exclusion Criteria
* Alanine aminotransferase (ALT) \> 5x upper limit of the normal range (ULN)
* Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
* Cirrhosis of the liver
* Prior history of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding
* Body mass index (BMI) \< 18 kg/m\^2
* Uncontrolled diabetes mellitus (hemoglobin A1c \> 9% at screening)
* International normalized ratio (INR) \> 1.2 unless on anticoagulant therapy
* Total bilirubin \> 1 x ULN, except with diagnosis of Gilbert's syndrome
18 Years
75 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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Addenbrooke's Hospital
Cambridge, , United Kingdom
Ruane Clinical Research Group Inc.
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Northwestern Memorial Hospital, Clinical Research Unit
Chicago, Illinois, United States
Crescent Clinical Research Center, LLC
Metairie, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Concorde Medical Group, PLLC
New York, New York, United States
Duke University Medical Center, Duke South Clinics
Durham, North Carolina, United States
Carolinas Center for Liver Disease/Carolinas HealthCare System
Durham, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Gastro One
Germantown, Tennessee, United States
Quality Medical Research, PC
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Texas Digestive Disease Consultants
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Pinnacle Clinical Research
Live Oak, Texas, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
Intermountain Liver Disease and Transplant Center
Murray, Utah, United States
Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia
Newport News, Virginia, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
Richmond, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, United States
University of Calgary
Calgary, Alberta, Canada
LMC Clinical Research Inc (Bayview)
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Liver Center
Toronto, Ontario, Canada
Toronto Digestive Disease Associates, Inc.
Vaughan, Ontario, Canada
Princess Margaret Hospital
Kowloon, , Hong Kong
The Chinese University of Hong Kong
Shatin, , Hong Kong
Auckland Clinical Studies
Auckland, , New Zealand
Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie
Bern, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
Countries
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References
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Patel K, Harrison SA, Elkhashab M, Trotter JF, Herring R, Rojter SE, Kayali Z, Wong VW, Greenbloom S, Jayakumar S, Shiffman ML, Freilich B, Lawitz EJ, Gane EJ, Harting E, Xu J, Billin AN, Chung C, Djedjos CS, Subramanian GM, Myers RP, Middleton MS, Rinella M, Noureddin M. Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial. Hepatology. 2020 Jul;72(1):58-71. doi: 10.1002/hep.31205.
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: Statistical Analysis Plan
Other Identifiers
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2016-002496-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-402-1852
Identifier Type: -
Identifier Source: org_study_id
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