Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
NCT ID: NCT02466516
Last Updated: 2019-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2015-06-08
2016-10-11
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
NONE
Study Groups
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SEL 6 mg
Selonsertib (SEL) 6 mg for 24 weeks.
SEL
SEL tablet administered orally once daily
SEL 18 mg
SEL 18 mg for 24 weeks.
SEL
SEL tablet administered orally once daily
SEL 6 mg+SIM 125 mg
SEL 6 mg plus SIM 125 mg for 24 weeks.
SEL
SEL tablet administered orally once daily
SIM
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
SEL 18 mg+SIM 125 mg
SEL 18 mg plus SIM 125 mg for 24 weeks.
SEL
SEL tablet administered orally once daily
SIM
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
SIM 125 mg
SIM 125 mg for 24 weeks.
SIM
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Interventions
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SEL
SEL tablet administered orally once daily
SIM
Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Evidence of NASH with fibrosis on biopsy
Exclusion Criteria
* Other causes of liver disease including viral hepatitis and alcoholic liver disease
* Any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
* History of liver transplantation
* Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1 oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine, and a 1 oz/30 mL measure of 40% proof alcohol)
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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Stanford University Medical Center
Palo Alto, California, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Northwestern University
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Methodist Dallas Medical Center
Dallas, Texas, United States
CHI St. Luke's Health Baylor College of Medicine
Houston, Texas, United States
Brooke Army Medical Center Ft. Sam
Houston, Texas, United States
Digestive Research Center
Live Oak, Texas, United States
American Research Corporation at Texas Liver Institute
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Mary Immaculate Hospital
Newport News, Virginia, United States
St. Mary's Hospital
Richmond, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
University of Calgary
Calgary, Alberta, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
Countries
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References
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Loomba R, Lawitz E, Mantry PS, Jayakumar S, Caldwell SH, Arnold H, et al. GS-4997, an inhibitor of apoptosis signal-regulating kinase (ASK1), alone or in combination with simtuzumab for the treatment of nonalcoholic steatohepatitis (NASH): a randomized, phase 2 trial. Hepatol 2016; 64 (6S): 1119A-1120A.
Diehl AM, French D, Xu R, et al. Treatment with selonsertib, an inhibitor of apoptosis signal-regulating kinase 1, hepatic phospho-p38 expression and markers of hepatocellular apoptosis and necrosis in patients with nonalcoholic steatohepatitis. J Hepatol 2017;66:S51. PS-090.
Middleton MS, Lawitz E, Jayakumar S, et al. Hepatic proton density fat fraction correlates with histologic measures of steatosis and is responsive to change in those measures in a multi-center nonalcoholic steatohepatitis clinical trial. J Hepatol 2017;66:S668. SAT-483.
Loomba R, Lawitz E, Ghalib R, et al. Longitudinal changes in liver stiffness by magnetic resonance elastography (MRE), liver fibrosis, and serum markers of fibrosis in a multi-center clinical trial in nonalcoholic steatohepatitis (NASH). J Hepatol 2017;66:S671. SAT-489.
Other Identifiers
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GS-US-384-1497
Identifier Type: -
Identifier Source: org_study_id
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