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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR IVACAFTOR

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Clinical Trials for Ivacaftor

Trial ID Title Status Sponsor Phase Summary
NCT00457821 Safety Study of Ivacaftor in Subjects With Cystic Fibrosis Completed Cystic Fibrosis Foundation Therapeutics Phase 2 The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
NCT00457821 Safety Study of Ivacaftor in Subjects With Cystic Fibrosis Completed Vertex Pharmaceuticals Incorporated Phase 2 The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
NCT00909532 Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation Completed Cystic Fibrosis Foundation Therapeutics Phase 3 The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
NCT00909532 Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 12 years and older who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic AMP-dependent protein kinase A (PKA) activation.
NCT00909727 Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation Completed Cystic Fibrosis Foundation Therapeutics Phase 3 The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.
NCT00909727 Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 The purpose of this study was to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Ivacaftor is a potent and selective potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.
NCT00953706 Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation Terminated Cystic Fibrosis Foundation Therapeutics Phase 2 The purpose of this study was to evaluate the safety and efficacy of ivacaftor in participants with cystic fibrosis (CF) who were aged 12 years or older and were homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation. Ivacaftor is a potent and selective CFTR potentiator of wild-type, G551D, F508del, and R117H forms of human CFTR protein. Potentiators are pharmacological agents that increase the chloride ion transport properties of the channel in the presence of cyclic adenosine monophosphate (AMP)-dependent protein kinase A (PKA) activation.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ivacaftor

Condition Name

Condition Name for Ivacaftor
Intervention Trials
Cystic Fibrosis 81
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation 2
Diabetes 2
Advanced Lung Disease 1
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Condition MeSH

Condition MeSH for Ivacaftor
Intervention Trials
Cystic Fibrosis 84
Fibrosis 75
Lung Diseases 3
Sinusitis 1
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Clinical Trial Locations for Ivacaftor

Trials by Country

Trials by Country for Ivacaftor
Location Trials
United States 868
Canada 68
United Kingdom 60
Australia 46
France 42
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Trials by US State

Trials by US State for Ivacaftor
Location Trials
Massachusetts 41
Missouri 36
Pennsylvania 36
Alabama 35
Illinois 34
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Clinical Trial Progress for Ivacaftor

Clinical Trial Phase

Clinical Trial Phase for Ivacaftor
Clinical Trial Phase Trials
Phase 4 8
Phase 3 40
Phase 2 20
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Clinical Trial Status

Clinical Trial Status for Ivacaftor
Clinical Trial Phase Trials
Completed 34
Recruiting 26
Not yet recruiting 11
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Clinical Trial Sponsors for Ivacaftor

Sponsor Name

Sponsor Name for Ivacaftor
Sponsor Trials
Vertex Pharmaceuticals Incorporated 66
Cystic Fibrosis Foundation Therapeutics 13
University of Alabama at Birmingham 7
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Sponsor Type

Sponsor Type for Ivacaftor
Sponsor Trials
Industry 72
Other 37
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fuji
Merck
Harvard Business School
US Department of Justice
Fish and Richardson
AstraZeneca
Farmers Insurance
Covington

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