- Trials with a EudraCT protocol (87)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
87 result(s) found for: ivacaftor AND vertex.
Displaying page 1 of 5.
EudraCT Number: 2017-001379-21 | Sponsor Protocol Number: VX15-770-126 | Start Date*: 2017-08-01 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Init... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-001314-41 | Sponsor Protocol Number: 69501 | Start Date*: 2019-05-06 |
Sponsor Name: | ||
Full Title: Kinetics of ivacaftor at Switch Orkambi Symkevi study | ||
Medical condition: Cystic fibrosis | ||
Disease: | ||
Population Age: Adults | Gender: Male, Female | |
Trial protocol: NL (Prematurely Ended) | ||
Trial results: (No results available) |
EudraCT Number: 2019-002254-23 | Sponsor Protocol Number: VX15-809-014 | Start Date*: 2019-06-10 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: A Phase 1, Randomized, Open-label Study to Evaluate the Relative Bioavailability, Food Effect, and Dose Proportionality of a Granule Formulation of Lumacaftor in Combination With Ivacaftor in Healt... | ||
Medical condition: Healthy Adult Subjects | ||
Disease: | ||
Population Age: Adults | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2023-000946-41 | Sponsor Protocol Number: VX19-809-124 | Start Date*: 2023-10-17 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 ... | ||
Medical condition: Cystic Fibrosis | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2020-000689-40 | Sponsor Protocol Number: VX19-661-012 | Start Date*: 2020-02-25 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Granule Formulation of Tezacaftor and Ivacaftor Compared to a Fixed-dose Combination Tablet in Healt... | |||||||||||||
Medical condition: | |||||||||||||
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Population Age: Adults | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2015-001997-16 | Sponsor Protocol Number: VX15-770-124 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Init... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Newborns, Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-005914-33 | Sponsor Protocol Number: VX21-445-125 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Ongoing) ES (Ongoing) SE (Ongoing) NO (Ongoing) NL (Ongoing) IT (Ongoing) BE (Ongoing) AT (Ongoing) PT (Ongoing) PL (Ongoing) HU (Ongoing) CZ (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2014-004827-29 | Sponsor Protocol Number: VX14-661-110 | Start Date*: 2015-09-01 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, ... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) IE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) SE (Completed) AT (Completed) FR (Completed) DK (Completed) NL (Completed) DE (Completed) ES (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-005224-12 | Sponsor Protocol Number: KAFTAC2020 | Start Date*: 2021-05-01 |
Sponsor Name:Haga Teaching Hospital | ||
Full Title: Elexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis using tacrolimus, a drug - drug interaction study | ||
Medical condition: cystic fibrosis patients | ||
Disease: | ||
Population Age: Adults | Gender: Male, Female | |
Trial protocol: NL (Ongoing) | ||
Trial results: (No results available) |
EudraCT Number: 2016-001004-33 | Sponsor Protocol Number: VX15-809-115 | Start Date*: 2018-01-10 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for t... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-004794-13 | Sponsor Protocol Number: VX16-809-122 | Start Date*: 2020-05-01 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | |||||||||||||
Medical condition: | |||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-004838-25 | Sponsor Protocol Number: VX14-661-109 | Start Date*: 2015-05-20 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With ... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Completed) IE (Completed) BE (Completed) AT (Completed) DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-000457-39 | Sponsor Protocol Number: VX16-770-127 | Start Date*: 2019-05-03 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: A Randomized, Double-blind, Placebo controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects with Cystic Fibrosis Who are 6 Years of Age and Older and Have Either a 3849 + 10KB... | ||
Medical condition: Cystic Fibrosis | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2017-001164-38 | Sponsor Protocol Number: VX15-661-113 | Start Date*: 2019-06-27 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous... | ||
Medical condition: Cystic Fibrosis (CF) | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2020-002239-31 | Sponsor Protocol Number: VX20-445-112 | Start Date*: 2022-03-18 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-002189-11 | Sponsor Protocol Number: VX15-661-112 | Start Date*: 2019-05-27 |
Sponsor Name:Vertex Pharmaceuticals Incorporated | ||
Full Title: A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cyst... | ||
Medical condition: Cystic Fibrosis | ||
Disease: | ||
Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2017-003761-99 | Sponsor Protocol Number: VX16-809-121 | Start Date*: 2018-06-27 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjec... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-001735-31 | Sponsor Protocol Number: VX18-445-109 | Start Date*: 2019-09-13 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) BE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2012-000389-39 | Sponsor Protocol Number: VX12-770-112 | Start Date*: 2012-10-25 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation | |||||||||||||
Medical condition: cystic fibrosis | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) BE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2014-000817-30 | Sponsor Protocol Number: TICTAC-2014 | Start Date*: 2014-08-14 |
Sponsor Name:University Medical Centre Utrecht | ||
Full Title: Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation | ||
Medical condition: Cystic Fibrosis | ||
Disease: | ||
Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | |
Trial protocol: NL (Completed) | ||
Trial results: View results |
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