A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating Mutation
Phase of Trial: Phase III
Latest Information Update: 24 Sep 2017
At a glance
- Drugs Ivacaftor (Primary)
- Indications Cystic fibrosis
- Focus Adverse reactions
- Sponsors Vertex Pharmaceuticals
- 11 Sep 2017 New trial record
- 10 Sep 2017 Planned End Date changed from 4 Jun 2021 to 7 Jun 2021.
- 10 Sep 2017 Planned primary completion date changed from 12 Mar 2021 to 7 Jun 2021.