18 completed, 1 recruiting. 7 Phase 1, 7 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 7 |
| Phase 3 | 7 | Completed 7 |
| Phase 2 | 4 | Completed 3, Recruiting 1 |
Follow lumacaftor: new trials by email Literature Review of lumacaftor trials Research Report on lumacaftor
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 |
|---|---|---|---|---|---|---|
| Lumacaftor Yields Reversal of Impaired Cerebral Blood Flow in Heart Failure Patients Lumacaftor 200 MG, Placebo - Heart Failure With Reduced Ejection Fraction | Phase 2 | Recruiting | Qanatpharma AG | 60 | 2026-07-01 | 2026-07-17 |
| Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet, Lumacaftor 200 mg Film-Coated Tablet Formulation - Healthy Volunteer | Phase 1 | Completed | Qanatpharma Canada LTD | 39 | 2023-11-17 | 2023-12-26 |
| Mutation-specific Therapy for the Long QT Syndrome Lumacaftor / Ivacaftor, Orkambi® Oral Tablet - Long QT Syndrome | Phase 2 | Completed | Istituto Auxologico Italiano | 16 | 2021-06-15 | 2025-04-25 |
| 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 |
| ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With Ivacaftor Lumacaftor plus Ivacaftor - Cystic Fibrosis | Completed | Hannover Medical School | 104 | 2016-06-01 | 2020-07-30 | |
| 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 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis Lumacaftor Plus Ivacaftor Combination, Ivacaftor - Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 1164 | 2013-10-01 | 2017-05-12 |
| 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 |
| Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects lumacaftor 200 mg q12h + ivacaftor 250 mg q12h - Hepatic Impairment, Healthy | Phase 1 | Completed | Vertex Pharmaceuticals Incorporated | 23 | 2013-06-01 | 2013-11-19 |
| 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 Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation Lumacaftor Plus Ivacaftor Combination, Ivacaftor, Placebo - Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 559 | 2013-05-01 | 2015-08-31 |
| 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 Placebo, Lumacaftor Plus Ivacaftor Combination, Ivacaftor - Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Phase 3 | Completed | Vertex Pharmaceuticals Incorporated | 563 | 2013-04-01 | 2016-09-27 |
| 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 |
| Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation Lumacaftor, Ivacaftor, Lumacaftor Placebo - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 312 | 2010-10-01 | 2015-10-05 |
| 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 (15) · Channelopathies (1) · Cognitive Dysfunction (1) · Death, Sudden, Cardiac (1) · Genetic Diseases, Inborn (1) · Infant, Newborn, Diseases (1) · Long QT Syndrome (1) · Lung Diseases (1) · Pancreatic Diseases (1)
Vertex Pharmaceuticals Incorporated (15) · Hannover Medical School (1) · Istituto Auxologico Italiano (1) · Qanatpharma AG (1) · Qanatpharma Canada LTD (1)
United States (12) · Canada (9) · Germany (7) · Australia (5) · Belgium (5) · France (5) · Netherlands (5) · United Kingdom (5) · Czechia (3) · Denmark (3) · Italy (3) · Sweden (3) · Austria (2) · Ireland (2) · Spain (2)
Isabella Szeto, MD, CCFP (1) · Kim Connelly (1) · Laurent Vernillet, PharmD, PhD, FCP (1) · Lia Crotti, MD (1) · Marcus Mall, MD (1) · Peter J Schwartz, MD (1)
PMID 33331662, PMID 37983082, PMID 25981758, PMID 27298017, PMID 30146268, PMID 30587335, PMID 36509366, PMID 21825083, PMID 24973281, PMID 27805836, PMID 27898234, PMID 28011037, PMID 28606620, PMID 29126871, PMID 29327948, PMID 33600745, PMID 35771568, PMID 40551045
2017 (1)