NCT02742519

A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation

A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long-term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy of ivacaftor treatment, as measured by lung clearance index (LCI), in subjects with cystic fibrosis (CF) who have a specified CF transmembrane conductance regulator (CFTR) gating mutation

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	ivacaftor
DRUG	Placebo

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-04-19
• Last updated: 2018-11-19
• Results posted: 2018-11-19

Locations

6 sites across 3 countries: Australia, Canada, United Kingdom