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 (link sends e-mail)
| Study Name on ClinicalTrials.gov (link is external) | A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation |
|---|---|
| Study Drug | ivacaftor |
| Type of Study Drug | CFTR Modulation |
| Study Title | A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long-term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation |
| Study Phase | 3 |
| Study Sponsor | Vertex |
https://clinicaltrials.gov/ct2/show/NCT02742519 (link is external) | |
| Participating ECFS-CTN sites | Please contact ecfs-ctn@uzleuven.be for most recent sitelist |
| Age | 3-5 Years |