10 completed. 5 Phase 1, 4 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 5 |
| Phase 3 | 4 | Completed 4 |
| Phase 2 | 1 | Completed 1 |
Follow VX-809: new trials by email Literature Review of VX-809 trials Research Report on VX-809
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del LUM, IVA - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 61 | 2018-09-07 | 2023-01-06 |
| A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation VX-809, Placebo, VX-770 - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 206 | 2015-07-01 | 2017-10-23 |
| Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease Lumacaftor, Ivacaftor - Cystic Fibrosis, Advanced Lung Disease | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 46 | 2015-03-01 | 2017-12-06 |
| A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor lumacaftor, ivacaftor - Cystic Fibrosis | Phase 1 | Completed | Vertex Pharmaceuticals Incorporated | 28 | 2013-07-01 | 2014-04-03 |
| Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Lumacaftor, Ivacaftor - Cystic Fibrosis | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 62 | 2013-07-01 | 2017-06-20 |
| Phase 1, QT/QTC Interval Study in Healthy Subjects Lumacaftor, Lumacaftor Placebo, Ivacaftor - Cystic Fibrosis | Phase 1 | Completed | Vertex Pharmaceuticals Incorporated | 200 | 2013-06-01 | 2014-08-11 |
| A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects Lumacaftor, Ivacaftor, Ciprofloxacin - Cystic Fibrosis | Phase 1 | Completed | Vertex Pharmaceuticals Incorporated | 80 | 2013-01-01 | 2013-11-15 |
| Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects VX-809, VX-770, VX-809 placebo - Cystic Fibrosis | Phase 1 | Completed | Vertex Pharmaceuticals Incorporated | 48 | 2010-10-01 | 2012-01-18 |
| Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects VX-809, VX-770, VX-809 & VX-770 - Cystic Fibrosis | Phase 1 | Completed | Vertex Pharmaceuticals Incorporated | 24 | 2009-09-01 | 2010-01-05 |
| Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation VX-809, Placebo - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 93 | 2009-03-01 | 2015-08-28 |
Cystic Fibrosis (10) · Genetic Diseases, Inborn (1) · Infant, Newborn, Diseases (1) · Lung Diseases (1) · Pancreatic Diseases (1)
Vertex Pharmaceuticals Incorporated (10)
United States (8) · Canada (4) · Netherlands (3) · Belgium (2) · Germany (2) · Australia (1) · Denmark (1) · France (1) · Sweden (1) · United Kingdom (1)
Laurent Vernillet, PharmD, PhD, FCP (1)
PMID 33331662, PMID 37983082, PMID 21825083, PMID 27805836, PMID 28606620, PMID 29126871, PMID 35771568
2017 (1)