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 of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation (TRAFFIC)
Study DrugIvacaftor (VX-770)
Lumacaftor (VX-809)
Type of Study DrugCFTR modulator
Study TitleA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
Study Phase3
Study SponsorVertex

Link on
clinicaltrials.gov (link is external)

http://clinicaltrials.gov/ct2/show/NCT01807923 (link is external)

Participating ECFS-CTN sitesCzech Republic: Prague
France: Strasbourg, Lyon, Roscoff, West-Paris
Germany: Berlin, Cologne
Italy: Florence, Genoa, Milan, Rome, Verona
The Netherlands: Rotterdam
Sweden: Gothenburg, Stockholm
UK: Belfast, Birmingham, Nottingham
Age12 Years to 65 Years