- Trials with a EudraCT protocol (24)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
24 result(s) found for: Regulator gene.
Displaying page 1 of 2.
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... | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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. [...] | ||
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 [...] | |||||||||||||
Full Title: A randomised, double-blind, placebo-controlled, cross-over trial of zibotentan in microvascular angina | |||||||||||||
Medical condition: Microvascular Angina and impaired exercise intolerance. | |||||||||||||
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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 | |||||||||||||
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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) | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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. | |||||||||||||
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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 | ||||||||||||||||||
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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 | |||||||||||||
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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: 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. | |||||||||||||
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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 | |||||||||||||
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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 | |||||||||||||
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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: 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) |
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 | |||||||||||||
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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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