NCT02514473

A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation

A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	VX-809
DRUG	Placebo
DRUG	VX-770

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-08-03
• Last updated: 2017-10-23
• Results posted: 2017-10-23

Locations

53 sites across 9 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Sweden, United Kingdom