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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR KALYDECO

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Clinical Trials for Kalydeco

Trial ID Title Status Sponsor Phase 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 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 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 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 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 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 Sponsor Phase Summary

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Clinical Trial Conditions for Kalydeco

Condition Name

Condition Name for Kalydeco
Intervention Trials
Cystic Fibrosis 18
Healthy 2
Chronic Rhinosinusitis (Diagnosis) 1
Chronic Obstructive Pulmonary Disease 1
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Condition MeSH

Condition MeSH for Kalydeco
Intervention Trials
Cystic Fibrosis 18
Fibrosis 16
Bronchitis 1
Acute Disease 1
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Clinical Trial Locations for Kalydeco

Trials by Country

Trials by Country for Kalydeco
Location Trials
United States 122
United Kingdom 9
Australia 4
Belgium 3
France 2
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Trials by US State

Trials by US State for Kalydeco
Location Trials
Alabama 9
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 4
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Clinical Trial Status

Clinical Trial Status for Kalydeco
Clinical Trial Phase Trials
Completed 8
Recruiting 6
Not yet recruiting 5
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Clinical Trial Sponsors for Kalydeco

Sponsor Name

Sponsor Name for Kalydeco
Sponsor Trials
Vertex Pharmaceuticals Incorporated 10
Cystic Fibrosis Foundation Therapeutics 5
University of Alabama at Birmingham 4
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Sponsor Type

Sponsor Type for Kalydeco
Sponsor Trials
Industry 15
Other 14
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Daiichi Sankyo
Chubb
McKesson
UBS
US Army
Mallinckrodt
Boehringer Ingelheim

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