A Phase 3, Open-Label, Rollover Study to Evaluate the Safety and Efficacy of Long-Term Treatment with XV-661 in Combination with Ivacaftor in Subjects Aged 12 Years and Older with Cystic Fibrosis, homozygous or Heterozygous for the F508del-Cftr Mutation
Principal Investigator (?)
This is a Phase 3, multicenter, open-label, 2-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in Studies NCT02070744, NCT02347657, NCT02516410, NCT02392234, NCT02412111, and NCT02508207. The study is designed to evaluate the safety and efficacy of long term treatment of VX-661 in combination with ivacaftor.
Vertex Pharmaceuticals, Inc
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