The ECFS-CTN cannot guarantee that the information provided here is comprehensive. Please go to the ClinicalTrials.gov link for detailed and up-to-date information on study background, eligibility criteria, study design, outcome measures, study status, participating sites, sponsor contact information and timelines.
You can also contact the CTN coordinating centre for additional information: ECFS-CTN@uzleuven.be
| Study Name on ClinicalTrials.gov (link is external) |
A 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 |
|---|---|
| Study Drug | ivacaftor |
| Type of Study Drug | CFTR modulator |
| Study Title | 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 |
| Study Phase | 3 |
| Study Sponsor | Vertex |
| Participating ECFS-CTN sites | Please contact ecfs-ctn@uzleuven.be for most recent sitelist |
| Age | up to 24 Months |