Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Cystic fibrosis transmembrane conductance regulator

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   44347   clinical trials with a EudraCT protocol, of which   7375   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    32 result(s) found for: Cystic fibrosis transmembrane conductance regulator. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2012-000387-19 Sponsor Protocol Number: VX11-770-110 Start Date*: 2012-06-11
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutation
    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: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-004063-21 Sponsor Protocol Number: BVT.BSSL-002 Start Date*: 2008-07-24
    Sponsor Name:Biovitrum AB
    Full Title: An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency.
    Medical condition: Cystic fibrosis and pancreatic insufficiency
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011762 Cystic fibrosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2008-007416-15 Sponsor Protocol Number: VX08-770-102 Start Date*: 2009-08-11
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) GB (Completed) DE (Completed) CZ (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004837-13 Sponsor Protocol Number: VX14-661-106 Start Date*: 2015-06-11
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double Blind, Placebo 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 Cy...
    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: IE (Completed) SE (Completed) GB (Completed) DK (Completed) IT (Completed) NL (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    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: 2015-003291-77 Sponsor Protocol Number: GLPG1837-CL-201 Start Date*: 2016-02-02
    Sponsor Name:Galapagos NV
    Full Title: A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation
    Medical condition: Cystic fibrosis with the G551D mutation
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002579-16 Sponsor Protocol Number: CF001 Start Date*: 2018-08-26
    Sponsor Name:Karolinska University Hospital, Stockholm CF center
    Full Title: Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus sp...
    Medical condition: Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane con...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10074549 Cystic fibrosis respiratory infection suppression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-010261-23 Sponsor Protocol Number: VX08-770-104 Start Date*: 2011-06-06
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis who are Homozygo...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004788-18 Sponsor Protocol Number: VX14-661-108 Start Date*: 2015-07-15
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Olde...
    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) DE (Completed) NL (Completed) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-002352-20 Sponsor Protocol Number: AC-056A202 Start Date*: 2008-08-11
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Single center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic...
    Medical condition: Cystic fibrosis homozygous for the F508del mutation
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011762 Cystic fibrosis LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (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: 2006-002049-35 Sponsor Protocol Number: AC-056-201 Start Date*: 2007-07-22
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: "Estudio unicéntrico, a doble ciego, aleatorizado y controlado con placebo, cruzado de 2 brazos, para investigar el efecto de miglustat sobre la diferencia de potencial nasal en pacientes con fibr...
    Medical condition: fibrosis quística
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011762 Cystic fibrosis LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-000543-16 Sponsor Protocol Number: VX14-809-109 Start Date*: 2015-06-19
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fib...
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) DK (Completed) BE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-005180-25 Sponsor Protocol Number: NM/BL-IIa-1106 Start Date*: 2006-12-15
    Sponsor Name:Nordmark Arzneimittel GmbH
    Full Title: A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiency Randomized, double-blind, placebo-controlled, s...
    Medical condition: Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment p...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011762 Cystic fibrosis LLT
    Population Age: Adults Gender: Male
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004277-26 Sponsor Protocol Number: GS-US-205-0110 Start Date*: 2008-04-29
    Sponsor Name:Gilead Sciences Inc
    Full Title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Int...
    Medical condition: Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011762 Cystic fibrosis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) GB (Completed) IE (Completed) DK (Completed) DE (Completed) NL (Completed) IT (Completed) PT (Completed) AT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-003990-24 Sponsor Protocol Number: VX12-809-104 Start Date*: 2013-06-25
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older Wit...
    Medical condition: Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) AT (Completed) GB (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2012-003989-40 Sponsor Protocol Number: VX12-809-103 Start Date*: 2013-05-07
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older Wit...
    Medical condition: Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) IT (Completed) CZ (Completed) DE (Completed) IE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000395-97 Sponsor Protocol Number: GS-US-205-0117 Start Date*: 2015-02-02
    Sponsor Name:Gilead Sciences, Inc. [...]
    1. Gilead Sciences, Inc.
    2. Gilead Sciences Pty Ltd
    3. Gilead Sciences Canada, Inc.
    Full Title: A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (A...
    Medical condition: Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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
    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: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001309-34 Sponsor Protocol Number: VX14-809-106 Start Date*: 2017-03-29
    Sponsor Name:Vertex Pharmaceuticals Incorporated
    Full Title: A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR ...
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed Jul 09 12:19:27 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA