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 Sep 2017
At a glance
- Drugs Ivacaftor/lumacaftor (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Vertex Pharmaceuticals
- 12 Sep 2017 Status changed from active, no longer recruiting to completed.
- 08 Aug 2017 Planned End Date changed from 1 Oct 2017 to 1 Sep 2017.
- 08 Aug 2017 Planned primary completion date changed from 1 Oct 2017 to 1 Sep 2017.