A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
Phase of Trial: Phase III
Latest Information Update: 06 Feb 2019
At a glance
- Drugs Ivacaftor/lumacaftor (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Vertex Pharmaceuticals
- 04 Oct 2018 Status changed from not yet recruiting to recruiting.
- 13 Aug 2018 Planned initiation date changed from 1 Jul 2018 to 1 Aug 2018.
- 01 Aug 2018 New trial record