- Trials with a EudraCT protocol (21)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
21 result(s) found for: elexacaftor AND vertex.
Displaying page 1 of 2.
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: 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) BE (Ongoing) AT (Ongoing) PT (Ongoing) PL (Ongoing) HU (Ongoing) CZ (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-004885-21 | Sponsor Protocol Number: VX20-445-121 | Start Date*: 2021-11-12 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: CZ (Completed) BE (Completed) NL (Ongoing) ES (Completed) | |||||||||||||
Trial results: (No results available) |
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: 2019-003455-11 | Sponsor Protocol Number: VX19-445-115 | Start Date*: 2020-01-17 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-005930-40 | Sponsor Protocol Number: VX21-121-105 | Start Date*: 2022-12-20 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Ongoing) FR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-001404-42 | Sponsor Protocol Number: VX20-445-119 | Start Date*: 2020-10-12 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozyg... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) DE (Ongoing) DK (Ongoing) NL (Ongoing) FR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-003554-86 | Sponsor Protocol Number: VX19-445-116 | Start Date*: 2020-08-14 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous fo... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) DK (Completed) GB (GB - no longer in EU/EEA) FR (Completed) NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-000694-85 | Sponsor Protocol Number: VX20-121-103 | Start Date*: 2021-12-03 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous ... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: NO (Ongoing) SE (Ongoing) DE (Ongoing) DK (Ongoing) IE (Ongoing) IT (Ongoing) GR (Ongoing) BE (Ongoing) AT (Ongoing) NL (Ongoing) PL (Ongoing) HU (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-003170-44 | Sponsor Protocol Number: VX19-445-117 | Start Date*: 2020-11-30 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: BE (Completed) CZ (Completed) FR (Completed) NL (Completed) IT (Ongoing) | |||||||||||||
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: 2018-001695-38 | Sponsor Protocol Number: VX18-445-106 | Start Date*: 2019-10-09 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) IE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2019-001827-11 | Sponsor Protocol Number: VX19-445-107 | Start Date*: 2020-04-24 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) IE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-001628-16 | Sponsor Protocol Number: VX20-445-126 | Start Date*: 2021-07-30 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for ... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Ongoing) BE (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2018-000185-11 | Sponsor Protocol Number: VX17-445-105 | Start Date*: Information not available in EudraCT | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Completed) DE (Ongoing) GB (GB - no longer in EU/EEA) CZ (Completed) BE (Completed) NL (Completed) AT (Completed) GR (Completed) FR (Completed) IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-002251-38 | Sponsor Protocol Number: VX20-445-111 | Start Date*: 2021-09-28 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age | |||||||||||||
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: 2018-002835-76 | Sponsor Protocol Number: VX18-445-104 | Start Date*: 2019-10-29 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation... | |||||||||||||
Medical condition: Cystic fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) IE (Completed) DE (Completed) DK (Completed) FR (Ongoing) BE (Completed) NL (Completed) IT (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-005320-38 | Sponsor Protocol Number: VX21-445-124 | Start Date*: 2022-01-21 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-re... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Children, Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Ongoing) DE (Ongoing) BE (Ongoing) AT (Ongoing) IT (Ongoing) PT (Ongoing) NL (Ongoing) SE (Ongoing) CZ (Ongoing) NO (Ongoing) HU (Ongoing) PL (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-000712-31 | Sponsor Protocol Number: VX20-121-102 | Start Date*: 2022-01-18 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minima... | |||||||||||||
Medical condition: Cystic Fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: SE (Ongoing) DE (Ongoing) CZ (Ongoing) IE (Ongoing) ES (Ongoing) PT (Ongoing) HU (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2019-000833-37 | Sponsor Protocol Number: VX18-445-110 | Start Date*: 2020-01-23 | |||||||||||
Sponsor Name:Vertex Pharmaceuticals Incorporated | |||||||||||||
Full Title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or... | |||||||||||||
Medical condition: Cystic fibrosis | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IE (Completed) DK (Completed) FR (Completed) BE (Completed) ES (Ongoing) NL (Completed) IT (Ongoing) | |||||||||||||
Trial results: (No results available) |
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