Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Clinical Trial
Official title:
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
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.
This is a Phase 3, parallel group, multicenter, rollover study in subjects with CF who are homozygous or heterozygous for the F508del CFTR mutation and who previously participated in Study 103, Study 104, or Cohort 4 of Study 102 ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment