PF-Atlas › Clinical Trials › NCT01705145

Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation

Ivacaftor · Phase 3

Registry ID
NCT01705145
Phase
Phase 3
Status
Completed
Drug / intervention
Ivacaftor
Sponsor
Vertex Pharmaceuticals Incorporated
Start
2013-01
Enrollment
35
Locations
20

About this trial

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.

View NCT01705145 on ClinicalTrials.gov →

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Medical disclaimer. This page summarizes public trial data for NCT01705145 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.