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Last Updated: November 24, 2024

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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 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 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 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 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 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KALYDECO

Condition Name

Condition Name for KALYDECO
Intervention Trials
Cystic Fibrosis 19
Chronic Obstructive Pulmonary Disease 3
Chronic Bronchitis 2
Healthy 2
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Condition MeSH

Condition MeSH for KALYDECO
Intervention Trials
Cystic Fibrosis 19
Fibrosis 17
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 162
United Kingdom 10
Canada 8
Australia 7
Belgium 4
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Trials by US State

Trials by US State for KALYDECO
Location Trials
Alabama 11
Massachusetts 9
California 9
Pennsylvania 8
Missouri 8
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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 16
Recruiting 6
Active, not recruiting 1
[disabled in preview] 3
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Clinical Trial Sponsors for KALYDECO

Sponsor Name

Sponsor Name for KALYDECO
Sponsor Trials
Vertex Pharmaceuticals Incorporated 13
University of Alabama at Birmingham 6
Cystic Fibrosis Foundation 5
[disabled in preview] 12
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Sponsor Type

Sponsor Type for KALYDECO
Sponsor Trials
Other 22
Industry 19
NIH 3
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