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Last Updated: September 19, 2020

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CLINICAL TRIALS PROFILE FOR KALYDECO

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All Clinical Trials for KALYDECO

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01614457 Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT) Completed Cystic Fibrosis Foundation Therapeutics Phase 3 2012-07-01 The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.
NCT01614457 Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT) Completed Vertex Pharmaceuticals Incorporated Phase 3 2012-07-01 The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.
NCT01614470 Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation Completed Cystic Fibrosis Foundation Therapeutics Phase 3 2012-07-01 The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).
NCT01614470 Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 2012-07-01 The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).
NCT01705145 Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation Completed Cystic Fibrosis Foundation Therapeutics Phase 3 2013-01-01 The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5 years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at least 1 allele. Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through 5 years of age.
NCT01705145 Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation Completed Vertex Pharmaceuticals Incorporated Phase 3 2013-01-01 The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), of ivacaftor in children with cystic fibrosis (CF) who are 2 through 5 years of age and have a CF Transmembrane Conductance Regulator (CFTR) gating mutation in at least 1 allele. Part A is designed to evaluate the safety and PK of multiple-dose administration of ivacaftor in participants 2 through 5 years of age and to confirm the doses for Part B. Part B is designed to evaluate the safety, PK, PD, and efficacy of ivacaftor in participants 2 through 5 years of age.
NCT01707290 Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation Completed Cystic Fibrosis Foundation Therapeutics Phase 3 2013-02-01 The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in subjects with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KALYDECO

Condition Name

Condition Name for KALYDECO
Intervention Trials
Cystic Fibrosis 18
Chronic Obstructive Pulmonary Disease 3
Chronic Bronchitis 2
Healthy 2
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Condition MeSH

Condition MeSH for KALYDECO
Intervention Trials
Cystic Fibrosis 18
Fibrosis 16
Pulmonary Disease, Chronic Obstructive 3
Lung Diseases, Obstructive 3
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Clinical Trial Locations for KALYDECO

Trials by Country

Trials by Country for KALYDECO
Location Trials
United States 123
United Kingdom 9
Australia 4
Belgium 3
Canada 2
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Trials by US State

Trials by US State for KALYDECO
Location Trials
Alabama 10
Massachusetts 8
Missouri 7
Illinois 7
Washington 6
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Clinical Trial Progress for KALYDECO

Clinical Trial Phase

Clinical Trial Phase for KALYDECO
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2 6
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Clinical Trial Status

Clinical Trial Status for KALYDECO
Clinical Trial Phase Trials
Completed 8
Recruiting 7
Not yet recruiting 6
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Clinical Trial Sponsors for KALYDECO

Sponsor Name

Sponsor Name for KALYDECO
Sponsor Trials
Vertex Pharmaceuticals Incorporated 12
University of Alabama at Birmingham 6
Cystic Fibrosis Foundation Therapeutics 5
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Sponsor Type

Sponsor Type for KALYDECO
Sponsor Trials
Industry 17
Other 16
NIH 3
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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Medtronic
Express Scripts
Merck
Mallinckrodt

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