A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Phase of Trial: Phase III
Latest Information Update: 06 Jul 2017
At a glance
- Drugs Ivacaftor/tezacaftor (Primary) ; Ivacaftor
- Indications Cystic fibrosis
- Focus Adverse reactions; Registrational
- Sponsors Vertex Pharmaceuticals
- 10 Jun 2017 Biomarkers information updated
- 15 Aug 2016 According to Vertex Pharmaceuticals media release, patients from part A of the parant study (VX14-661-107) who were enrolled in the this long-term extension study will be transitioned off the combination of VX-661 and ivacaftor.
- 28 Apr 2016 Planned number of patients changed from 1375 to 1292.