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 Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation |
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Study Drug | Tezacaftor in combination with ivacaftor |
Type of Study Drug | CFTR modulator |
Study Title | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation |
Study Phase | 3 |
Study Sponsor | Vertex |
https://clinicaltrials.gov/ct2/show/NCT03537651?term=661-116&rank=1 |
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Participating ECFS-CTN sites | Please contact ecfs-ctn@uzleuven.be for most recent sitelist |
Age | 6 years and older |