NCT02544451

Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor

A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109 (NCT02514473) or Study 011B (NCT01897233). Study 110 is designed to evaluate the safety and efficacy of long term treatment of lumacaftor in combination with ivacaftor.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	LUM/IVA	Lumacaftor (LUM) 200 mg every 12 hours (q12h)/ivacaftor (IVA) 250 mg q12h (for 6 through 11 years of age). LUM 400 mg q12h/IVA 250 mg q12h (for 12 years and older).
DRUG	LUM/IVA	LUM 200 mg q12h/IVA 250 mg q12h (for 6 through 11 years of age).

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-08-01
• Completion: 2020-04-01
• First posted: 2015-09-09
• Last updated: 2021-05-24
• Results posted: 2019-10-29

Locations

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