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Clinical trials for Gating

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    16 result(s) found for: Gating. Displaying page 1 of 1.
    EudraCT Number: 2012-000388-26 Sponsor Protocol Number: VX12-770-111 Start Date*: 2012-07-23
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Ha...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002837-31 Sponsor Protocol Number: GLPG2222-CL-201 Start Date*: 2016-12-02
    Sponsor Name:Galapagos NV
    Full Title: A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (cla...
    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: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) BE (Completed) CZ (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: 2011-002070-23 Sponsor Protocol Number: EEGrofl Start Date*: 2011-10-12
    Sponsor Name:Maastricht University Medical Center
    Full Title: Effects of roflumilast on cognition in healthy adults: a behaviour-EEG study
    Medical condition: None; this proof-of-principle study will examine the cognition enhancing effects of roflumilast in healthy subjects
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    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
    EudraCT Number: 2012-000204-15 Sponsor Protocol Number: VX11-770-108 Start Date*: 2013-06-28
    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 2 Through 5 Years of Age and Have a CFTR Gat...
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    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
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    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: 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
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    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: 2015-001267-39 Sponsor Protocol Number: VX15-770-123 Start Date*: 2016-06-20
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years ...
    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) FR (Ongoing)
    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: 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
    EudraCT Number: 2011-003821-93 Sponsor Protocol Number: VX11-661-101 Start Date*: 2013-03-13
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subject...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    16.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-000386-20 Sponsor Protocol Number: VX11-770-109 Start Date*: 2013-07-31
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2007-005088-82 Sponsor Protocol Number: CAFQ056A2204 Start Date*: 2008-05-15
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of mul...
    Medical condition: Fragile X Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017324 Fragile X syndrome PT
    Population Age: Adults Gender: Male
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001785-29 Sponsor Protocol Number: ARIS2 Start Date*: 2016-08-15
    Sponsor Name:St. Vincent's University Hospital
    Full Title: Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment
    Medical condition: Cystic fibrosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
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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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