A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have a CFTR Gating Mutation
Phase of Trial: Phase III
Latest Information Update: 17 Oct 2017
At a glance
- Drugs Ivacaftor (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacokinetics; Registrational
- Sponsors Vertex Pharmaceuticals
- 15 Aug 2017 Planned End Date changed from 1 Sep 2018 to 1 Jun 2020.
- 15 Aug 2017 Planned primary completion date changed from 1 Sep 2018 to 1 Jun 2020.
- 06 Oct 2016 Planned number of patients changed from 30 to 35.