A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Phase of Trial: Phase III
Latest Information Update: 15 Jan 2018
At a glance
- Drugs Ivacaftor/lumacaftor (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacokinetics; Registrational
- Sponsors Vertex Pharmaceuticals
- 25 Oct 2017 According to a Vertex Pharmaceuticals media release, the company expects to submit a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) line extension to the European Medicines Agency (EMA) in the first quarter of 2018 based on results from this study.
- 25 Oct 2017 According to a Vertex Pharmaceuticals media release, the company has announced results from this trial.
- 12 Sep 2017 Status changed from active, no longer recruiting to completed.