24 completed, 2 terminated, 1 active not recruiting, 1 withdrawn. 28 Phase 2, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 28 | Completed 24, Terminated 2, Active not recruiting 1, Withdrawn 1 |
| Phase 1 | 3 | Completed 3 |
Follow ivacaftor: new trials by email Literature Review of ivacaftor trials Research Report on ivacaftor
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 |
|---|---|---|---|---|---|---|
| A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF RCT2100, Placebo, Ivacaftor - Cystic Fibrosis | Phase 2 | Active not recruiting | ReCode Therapeutics | 128 | 2024-02-01 | 2026-08-19 |
| A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF) VX-522 mRNA therapy, IVA - Cystic Fibrosis | Phase 1 / Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 26 | 2023-02-27 | 2026-10-09 |
| The Multicenter Topic Trial Ivacaftor - Chronic Obstructive Pulmonary Disease | Phase 2 | Withdrawn | University of Alabama at Birmingham | 2021-12-01 | 2022-01-27 | |
| 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 |
| A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele ELX-02, Ivacaftor - Cystic Fibrosis | Phase 2 | Completed | Eloxx Pharmaceuticals, Inc. | 17 | 2019-11-25 | 2022-11-22 |
| A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele ELX-02, Ivacaftor - Cystic Fibrosis | Phase 2 | Completed | Eloxx Pharmaceuticals, Inc. | 17 | 2019-11-05 | 2023-08-21 |
| Trikafta in Cystic Fibrosis Patients Trikafta - Cystic Fibrosis | Phase 2 | Completed | Emory University | 42 | 2019-09-04 | 2026-08-11 |
| Gut Imaging for Function & Transit in Cystic Fibrosis Study 2 Tezacaftor/Ivacaftor + Ivacaftor, Placebo oral tablet - Cystic Fibrosis | Phase 2 | Completed | Nottingham University Hospitals NHS Trust | 12 | 2019-09-03 | 2023-05-24 |
| A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis VX-121, TEZ, VX-561 - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 87 | 2019-04-30 | 2023-04-20 |
| A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis VX-561, IVA, Placebo - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 77 | 2019-04-17 | 2022-01-25 |
| Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis Placebo (matched to VX-121 suspension), VX-121 (Suspension), TEZ/IVA - Cystic Fibrosis | Phase 1 / Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 115 | 2018-03-20 | 2022-07-14 |
| A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis VX-659, TEZ/IVA, IVA - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 124 | 2017-08-08 | 2021-04-22 |
| The Topic Trial - Study to Determine the Safety and Efficacy of Ivacaftor Ivacaftor 150 MG, Placebo - Chronic Obstructive Pulmonary Disease, Chronic Bronchitis | Phase 2 | Completed | University of Alabama at Birmingham | 40 | 2017-03-16 | 2024-12-12 |
| A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis IVA, TEZ/IVA, VX-445 - Cystic Fibrosis | Phase 1 / Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 225 | 2017-01-23 | 2022-01-18 |
| Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations VX-561, Placebo, IVA - Cystic Fibrosis | Phase 2 | Terminated | Vertex Pharmaceuticals Incorporated | 11 | 2016-12-01 | 2020-08-26 |
| A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis VX-152, TEZ/IVA, IVA - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 80 | 2016-11-01 | 2021-01-28 |
| A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis TEZ, IVA, VX-440 - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 74 | 2016-10-01 | 2020-08-28 |
| A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Tezacaftor/Ivacaftor, Ivacaftor, Placebo - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 41 | 2016-09-01 | 2019-10-23 |
| Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia VX-371, Hypertonic Saline, Placebo (0.17% saline) - Primary Ciliary Dyskinesia | Phase 2 | Completed | Parion Sciences | 123 | 2016-08-01 | 2021-12-16 |
| A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Tezacaftor/Ivacaftor, Ivacaftor, Tezacaftor/Ivacaftor matching placebo - Cystic Fibrosis | Phase 2 | Completed | Vertex Pharmaceuticals Incorporated | 34 | 2016-02-01 | 2021-07-19 |
Showing 20 of 28. Sign in to see all of them.
Cystic Fibrosis (24) · Digestive System Diseases (2) · Fibrosis (2) · Genetic Diseases, Inborn (2) · Infant, Newborn, Diseases (2) · Lung Diseases (2) · Pancreatic Diseases (2) · Pathologic Processes (2) · Pulmonary Disease, Chronic Obstructive (2) · Respiratory Tract Diseases (2) · Bronchitis, Chronic (1) · Channelopathies (1) · Ciliary Motility Disorders (1) · Death, Sudden, Cardiac (1) · Long QT Syndrome (1)
Vertex Pharmaceuticals Incorporated (19) · Eloxx Pharmaceuticals, Inc. (2) · University of Alabama at Birmingham (2) · Emory University (1) · Istituto Auxologico Italiano (1) · Nottingham University Hospitals NHS Trust (1) · Parion Sciences (1) · ReCode Therapeutics (1)
United States (22) · United Kingdom (12) · Germany (9) · Australia (7) · Canada (7) · Netherlands (6) · Belgium (5) · Italy (3) · Denmark (2) · France (2) · Ireland (2) · Israel (2) · New Zealand (2) · Austria (1) · Poland (1)
Alan Smyth, Prof (1) · Eric Sorscher, MD (1) · Felix Ratjen (1) · Giles Major, Dr (1) · Jane Davies (1) · Jerry Nick, MD (1) · John Matthews, MBBS, MCRP, PhD (1) · Karl Donn (1) · Lia Crotti, MD (1) · Mark Dransfield, MD (1) · Patrick A Flume, MD (1) · Peter J Schwartz, MD (1) · Scott Donaldson, MD (1) · Talissa Altes, MD (1)
PMID 33331662, PMID 37983082, PMID 36842446, PMID 21083385, PMID 22383668, PMID 24461666, PMID 24660233, PMID 24973281, PMID 27898234, PMID 28132845, PMID 30334692, PMID 30334693, PMID 31784217, PMID 37660715, PMID 39139270, PMID 39208836, PMID 39316773, PMID 42271629
2016 (2), 2018 (2), 2009 (1), 2015 (1), 2017 (1), 2023 (1), P30DK072482 (1), R01HL139876 (1), R34HL127166 (1)