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 Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis |
|---|---|
| Study Drug | Ivacaftor (VX-770) Lumacaftor (VX-809) |
| Type of Study Drug | CFTR Modulation |
| Study Title | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation |
| Study Phase | 3 |
| Study Sponsor | Vertex |
http://clinicaltrials.gov/ct2/show/NCT01931839 (link is external) | |
| Participating ECFS-CTN sites | Belgium: Leuven Czech Republic : Prague Denmark : Copenhagen France: Bordeaux, Toulouse, Strasbourg, Lyon, Marseille, Montpellier, Roscoff, Nantes, West-Paris, Germany : Berlin, Frankfurt, Hannover, Cologne, Munich Italy: Florence, Genoa, Milan, Rome, Verona The Netherlands: Rotterdam Spain: Barcelona Sweden: Gothenburg, Stockholm UK: Belfast, Birmingham, Leeds, London, Nottingham |
| Age | 12 Years and older |