CLINICAL TRIALS PROFILE FOR IVACAFTOR

All Clinical Trials for ivacaftor

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00457821 ↗	Safety Study of Ivacaftor in Subjects With Cystic Fibrosis	Completed	Cystic Fibrosis Foundation	Phase 2	2007-05-01	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	Cystic Fibrosis Foundation Therapeutics	Phase 2	2007-05-01	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	2007-05-01	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	Phase 3	2009-06-01	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	Cystic Fibrosis Foundation Therapeutics	Phase 3	2009-06-01	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	2009-06-01	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.

Clinical Trial Conditions for ivacaftor

Condition Name

Condition Name for ivacaftor
Intervention	Trials
Cystic Fibrosis	110
Chronic Obstructive Pulmonary Disease	3
Healthy Volunteer	2
Cystic Fibrosis, Homozygous for the F508del CFTR Mutation	2

Condition MeSH

Condition MeSH for ivacaftor
Intervention	Trials
Cystic Fibrosis	113
Fibrosis	106
Lung Diseases	5
Pulmonary Disease, Chronic Obstructive	3

Clinical Trial Locations for ivacaftor

Trials by Country

Trials by Country for ivacaftor
Location	Trials
Canada	96
United Kingdom	83
Australia	65
Germany	61
France	55

Trials by US State

Trials by US State for ivacaftor
Location	Trials
Massachusetts	55
California	53
Missouri	52
Ohio	51
Pennsylvania	50

Clinical Trial Progress for ivacaftor

Clinical Trial Phase

Clinical Trial Phase for ivacaftor
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	59
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for ivacaftor
Clinical Trial Phase	Trials
Completed	76
Recruiting	17
Active, not recruiting	12

Clinical Trial Sponsors for ivacaftor

Sponsor Name

Sponsor Name for ivacaftor
Sponsor	Trials
Vertex Pharmaceuticals Incorporated	93
Cystic Fibrosis Foundation	14
Cystic Fibrosis Foundation Therapeutics	13

Sponsor Type

Sponsor Type for ivacaftor
Sponsor	Trials
Industry	105
Other	76
NIH	5