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Clinical trials for Elexacaftor

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    22 result(s) found for: Elexacaftor. Displaying page 1 of 2.
    1  2  Next»
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing) ES (Ongoing) SE (Trial now transitioned) NO (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) CZ (Trial now transitioned) FR (Trial now transitioned)
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) NL (Completed) FR (Completed)
    Trial results: View results
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) NL (Ongoing) ES (Completed)
    Trial results: View results
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    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: 2021-005930-40 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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) FR (Trial now transitioned)
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) FR (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) FR (Completed) BE (Completed) AT (Completed) IT (Completed) PT (Completed) NL (Completed) SE (Completed) CZ (Completed) NO (Completed) HU (Completed) PL (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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed) DE (Completed) DK (Completed) IE (Completed) IT (Completed) GR (Completed) BE (Completed) AT (Completed) NL (Completed) PL (Completed) HU (Completed)
    Trial results: View results
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed)
    Trial results: View results
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed)
    Trial results: View results
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) CZ (Completed) IE (Completed) ES (Ongoing) PT (Completed) HU (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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) 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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) BE (Completed) NL (Completed) AT (Completed) GR (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-000476-18 Sponsor Protocol Number: SPX-CF-001 Start Date*: 2022-05-24
    Sponsor Name:EnBiotix, Inc.
    Full Title: Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aerugin...
    Medical condition: Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Ongoing) SK (Prematurely Ended) PL (Completed)
    Trial results: (No results available)
    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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed) DE (Completed) DK (Completed) FR (Completed) BE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
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