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Clinical trials for tezacaftor ivacaftor AND vertex

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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    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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    37 result(s) found for: tezacaftor ivacaftor AND vertex. Displaying page 2 of 2.
    « Previous 1  2 
    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: 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: 2016-003585-11 Sponsor Protocol Number: VX16-659-101 Start Date*: 2017-09-01
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older 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: Adults Gender: Male, Female
    Trial protocol: IE (Completed) GB (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: 2018-004652-38 Sponsor Protocol Number: VX18-445-113 Start Date*: 2020-01-15
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 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 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) PL (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: 2016-000454-36 Sponsor Protocol Number: VX15-440-101 Start Date*: 2017-01-10
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) DK (Prematurely Ended) DE (Completed) BE (Completed) ES (Prematurely Ended) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000184-89 Sponsor Protocol Number: VX17-445-103 Start Date*: 2018-09-27
    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 Homozygous for the F508del Mutation (...
    Medical condition:
    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) NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000540-18 Sponsor Protocol Number: VX16-661-114 Start Date*: Information not available in EudraCT
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population ...
    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: FR (Completed) DE (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: 2016-004479-35 Sponsor Protocol Number: VX16-661-115 Start Date*: Information not available in EudraCT
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or...
    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: IE (Completed) DK (Completed) BE (Completed) DE (Completed) GB (Completed) PL (Completed) FR (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: 2017-004132-11 Sponsor Protocol Number: VX17-659-102 Start Date*: 2018-05-02
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 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) DE (Completed) DK (Completed) IE (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-000126-55 Sponsor Protocol Number: VX17-121-001 Start Date*: 2018-03-15
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 1/2 Study of VX-121 in Healthy Subjects and 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: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000797-11 Sponsor Protocol Number: VX16-445-001 Start Date*: 2017-10-06
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 1/2 Study of VX-445 in Healthy Subjects and 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: Adults Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed)
    Trial results: View results
    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
    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: DE (Completed) GB (GB - no longer in EU/EEA) IE (Completed) DK (Completed) FR (Completed) BE (Completed) ES (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000183-28 Sponsor Protocol Number: VX17-445-102 Start Date*: 2018-08-27
    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:
    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 (Completed) CZ (Completed) BE (Completed) NL (Completed) AT (Completed) GR (Completed) FR (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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