NCT01931839

A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis

A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,164 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.

Detailed description

This is a Phase 3, parallel group, multicenter, rollover study in participants with CF who are homozygous or heterozygous for the F508del CFTR mutation and who previously participated in Study 103 (Study VX12-809-103, NCT01807923), Study 104 (Study VX12-809-104, NCT01807949), or Cohort 4 of Study 102 (Study VX09-809-102, NCT01225211).

Conditions

• Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Interventions

Type	Name	Description
DRUG	Lumacaftor Plus Ivacaftor Combination	Fixed dose combination tablet, oral use
DRUG	Ivacaftor	Film-coated tablet, oral use

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-08-29
• Last updated: 2017-05-12
• Results posted: 2017-05-12

Locations

166 sites across 15 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Sweden, United Kingdom