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 and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation |
|---|---|
| Study Drug | Lumacaftor/Ivacaftor |
| Type of Study Drug | CFTR modulator |
| Study Title | An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del |
| Study Phase | 2a |
| Study Sponsor | Vertex |
|
https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003761-99/DE |
|
| Participating ECFS-CTN sites | Please contact ecfs-ctn@uzleuven.be for most recent sitelist |
| Age | 2 through 5 years of age |