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Clinical trials for Regulator Gene

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    24 result(s) found for: Regulator Gene. Displaying page 1 of 2.
    1  2  Next»
    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: 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: 2016-003967-21 Sponsor Protocol Number: MGT009 Start Date*: 2017-06-09
    Sponsor Name:MeiraGTx UK II Limited
    Full Title: An open label, multi-centre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/5-hRKp.RPGR) for gene therapy of adults and children with X-linked Retinitis Pigme...
    Medical condition: X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000425-31 Sponsor Protocol Number: MGT010 Start Date*: 2018-08-30
    Sponsor Name:MeiraGTx UK II Ltd
    Full Title: Long term follow-up study of participants following an open label, multicentre, Phase I/II dose escalation trial of a recombinant adeno-associated virus vector (AAV2/5-hRKp.RPGR) for gene therapy o...
    Medical condition: X-Linked Retinitis Pigmentosa caused by mutations in the RPGR gene
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: (No results available)
    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: 2018-004393-10 Sponsor Protocol Number: GN18CA068 Start Date*: 2019-07-17
    Sponsor Name:NHS Greater Glasgow & Clyde [...]
    1. NHS Greater Glasgow & Clyde
    2. University of Glasgow
    Full Title: A randomised, double-blind, placebo-controlled, cross-over trial of zibotentan in microvascular angina
    Medical condition: Microvascular Angina and impaired exercise intolerance.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10065566 Microvascular angina LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    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
    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: 2016-003852-60 Sponsor Protocol Number: NSR-RPGR-01 Start Date*: 2017-01-09
    Sponsor Name:NightstaRx Limited
    Full Title: A Dose Escalation (Phase 1), and Dose Expansion (Phase 2/3) Clinical Trial of Retinal Gene Therapy for X-linked Retinitis Pigmentosa Using an Adeno-Associated Viral Vector (AAV8) Encoding Retinitis...
    Medical condition: X-Linked retinitis pigmentosa (XLRP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10038914 Retinitis pigmentosa PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    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 (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    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: 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: 2018-001207-37 Sponsor Protocol Number: HUB-IDIBELL-SAFO-4.3.1 Start Date*: 2019-04-26
    Sponsor Name:Miquel Pujol i Rojo ( Servicio de Enfermedades Infecciosas del Hospital Universitari de Bellvitge
    Full Title: Phase IV-III Clinical Trial, randomized, controlled, open and multicentric, with parallel groups, to evaluate the efficacy of Cloxacillin and fosfomycin combination versus Cloxacillin monotherapy i...
    Medical condition: Methicilin-susceptible S.aureus bacteraemia.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10058863 Staphylococcus aureus bacteraemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019634-26 Sponsor Protocol Number: MPEX-209 Start Date*: 2011-05-24
    Sponsor Name:Mpex Pharmaceuticals, Inc.
    Full Title: A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients
    Medical condition: Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    14.0 10021881 - Infections and infestations 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FR (Ongoing) IE (Completed)
    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: 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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-011740-19 Sponsor Protocol Number: GS-US-205-0127 Start Date*: 2015-02-02
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Phase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects with Cystic Fibrosis (CF) a...
    Medical condition: Cystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-000398-11 Sponsor Protocol Number: GS-US-205-0170 Start Date*: 2015-02-03
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for t...
    Medical condition: Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: 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: 2014-004787-37 Sponsor Protocol Number: VX14-661-107 Start Date*: 2015-09-21
    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: AT (Completed) DE (Completed) ES (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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