A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi
Phase of Trial: Phase II
Latest Information Update: 14 Nov 2017
At a glance
- Drugs P 1037 (Primary) ; Ivacaftor; Lumacaftor
- Indications Cystic fibrosis
- Focus Adverse reactions; Therapeutic Use
- Sponsors Vertex Pharmaceuticals
- 25 Oct 2017 Primary endpoint (Absolute change in percent predicted forced expiratory volume in 1 second (FEV1)) has not been met, according to a Vertex Pharmaceuticals media release.
- 03 Oct 2017 Status changed from active, no longer recruiting to completed.
- 09 Aug 2017 Planned primary completion date changed from 25 Jul 2017 to 22 Aug 2017.