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: 29 Jan 2018
At a glance
- Drugs Ivacaftor/tezacaftor (Primary) ; Ivacaftor
- Indications Cystic fibrosis
- Focus Adverse reactions; Registrational
- Sponsors Vertex Pharmaceuticals
- 18 Aug 2017 Planned End Date changed from 1 Jul 2019 to 1 Sep 2019.
- 18 Aug 2017 Planned primary completion date changed from 1 Jun 2019 to 1 Jul 2019.
- 18 Aug 2017 Planned number of patients changed from 1292 to 1116.