Clinical Trials (EU)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001862-56

EudraCT Number: 2017-001862-56

Sponsor Protocol Number: 64041575RSV2004

Sponsor Name: Janssen-Cilag International NV

Start Date: 2018-01-09

Medical condition: Respiratory syncytial virus infection

Disease:

Version: 20.0

SOC Term: 10021881 – Infections and infestations

Classification Code: 10061603

Term: Respiratory syncytial virus infection

Level: PT

Population Age: Infants and toddlers, Children, Under 18

Gender: Male, Female

Trial Protocol: GB (Ongoing), DE (Prematurely Ended), BE (Prematurely Ended), FI (Prematurely Ended), SK (Prematurely Ended), ES (Prematurely Ended), IE (Prematurely Ended), PT (Prematurely Ended), FR (Prematurely Ended), IT (Temporarily Halted)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (…

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001862-56

Last Update Posted: 05/10/19 09:44AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003723-29

EudraCT Number: 2017-003723-29

Sponsor Protocol Number: JBT101-CF-002

Sponsor Name: Corbus Pharmaceuticals, Inc.

Start Date: 2018-11-19

Medical condition: Cystic Fibrosis (CF)

Disease:

Version: 20.0

SOC Term: 10010331 – Congenital, familial and genetic disorders

Classification Code: 10011762

Term: Cystic fibrosis

Level: PT

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial Protocol: DE (Ongoing), HU (Ongoing), SE (Ongoing), FR (), PT (Ongoing), SK (Ongoing), AT (Ongoing), BE (Ongoing), ES (Ongoing), BG (), NL (Ongoing), CZ (Ongoing), GR (Ongoing)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003723-29

Last Update Posted: 04/18/19 08:50AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002533-32

EudraCT Number: 2017-002533-32

Sponsor Protocol Number: INS1007-201

Sponsor Name: Insmed Incorporated

Start Date: 2018-03-15

Medical condition: Non-Cystic Fibrosis Bronchiectasis

Disease:

Version: 20.0

SOC Term: 10038738 – Respiratory, thoracic and mediastinal disorders

Classification Code: 10038738

Term: Respiratory, thoracic and mediastinal disorders

Level: SOC

Version: 20.1

SOC Term: 10038738 – Respiratory, thoracic and mediastinal disorders

Classification Code: 10006445

Term: Bronchiectasis

Level: PT

Population Age: Adults, Elderly

Gender: Male, Female

Trial Protocol: DE (Ongoing), SE (Ongoing), ES (Ongoing), NL (Ongoing), BG (Ongoing), PL (Ongoing), BE (Ongoing)

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 We…

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002533-32

Last Update Posted: 04/17/19 06:26AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004132-11

EudraCT Number: 2017-004132-11

Sponsor Protocol Number: VX17-659-102

Sponsor Name: Vertex Pharmaceuticals Incorporated

Start Date: 2018-04-25

Medical condition: Cystic fibrosis

Disease:

Version: 20.0

SOC Term: 10010331 – Congenital, familial and genetic disorders

Classification Code: 10011762

Term: Cystic fibrosis

Level: PT

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial Protocol: DE (Completed), DK (Completed), IE (Ongoing), ES (Completed), PL ()

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…

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004132-11

Last Update Posted: 04/17/19 03:59AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004134-29

EudraCT Number: 2017-004134-29

Sponsor Protocol Number: VX17-659-105

Sponsor Name: Vertex Pharmaceuticals Incorporated

Start Date: Information not available in EudraCT

Medical condition: Cystic fibrosis

Disease:

Version: 20.0

SOC Term: 10010331 – Congenital, familial and genetic disorders

Classification Code: 10011762

Term: Cystic fibrosis

Level: PT

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial Protocol: DE (), IE (Ongoing), ES (Ongoing), DK (Ongoing), PL (Ongoing)

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004134-29

Last Update Posted: 04/16/19 09:31AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003831-31

EudraCT Number: 2018-003831-31

Sponsor Protocol Number: MS1819/18/02

Sponsor Name: AzurRx

Start Date: 2019-03-28

Medical condition: Exocrine Pancreatic Insufficiency

Disease:

Version: 20.0

SOC Term: 100000004856

Classification Code: 10033628

Term: Pancreatic insufficiency

Level: LLT

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial Protocol: HU (Ongoing)

A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe…

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003831-31

Last Update Posted: 04/16/19 05:29AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004558-13

EudraCT Number: 2016-004558-13

Sponsor Protocol Number: Z7224L02

Sponsor Name: Zambon S.p.A.

Start Date: 2017-05-30

Medical condition: Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa

Disease:

Version: 19.1

SOC Term: 10038738 – Respiratory, thoracic and mediastinal disorders

Classification Code: 10006445

Term: Bronchiectasis

Level: PT

Population Age: Adults, Elderly

Gender: Male, Female

Trial Protocol: FR (Ongoing), PL (Ongoing)

A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of sub…

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004558-13

Last Update Posted: 04/10/19 05:57AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004479-35

EudraCT Number: 2016-004479-35

Sponsor Protocol Number: VX16-661-115

Sponsor Name: Vertex Pharmaceuticals Incorporated

Start Date: Information not available in EudraCT

Medical condition: Cystic Fibrosis

Disease:

Version: 20.0

SOC Term: 10010331 – Congenital, familial and genetic disorders

Classification Code: 10011762

Term: Cystic fibrosis

Level: PT

Population Age: Children, Under 18

Gender: Male, Female

Trial Protocol: IE (Completed), DK (Completed), BE (Completed), DE (Completed), PL (Ongoing), FR (Completed)

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…

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004479-35

Last Update Posted: 04/06/19 04:35AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003040-39

EudraCT Number: 2015-003040-39

Sponsor Protocol Number: CTBM100G2202

Sponsor Name: Novartis Pharma Services AG

Start Date: 2016-09-29

Medical condition: Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis

Disease:

Version: 19.0

SOC Term: 10038738 – Respiratory, thoracic and mediastinal disorders

Classification Code: 10006445

Term: Bronchiectasis

Level: PT

Version: 19.0

SOC Term: 10021881 – Infections and infestations

Classification Code: 10070295

Term: Infective exacerbation of bronchiectasis

Level: PT

Population Age: Adults, Elderly

Gender: Male, Female

Trial Protocol: ES (Ongoing), BE (Completed), DE (Ongoing), IE (Temporarily Halted), NL (Ongoing), GB (Ongoing), IT (Temporarily Halted)

A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cysti…

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003040-39

Last Update Posted: 04/05/19 08:21AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004915-35

EudraCT Number: 2014-004915-35

Sponsor Protocol Number: CQBW276X2201

Sponsor Name: Novartis Pharma AG

Start Date: 2017-07-26

Medical condition: Cystic Fibrosis

Disease:

Version: 20.0

SOC Term: 10010331 – Congenital, familial and genetic disorders

Classification Code: 10011762

Term: Cystic fibrosis

Level: PT

Population Age: Adults

Gender: Male, Female

Trial Protocol: DE (Prematurely Ended), GB (Ongoing)

A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004915-35

Last Update Posted: 04/05/19 07:37AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002699-14

EudraCT Number: 2012-002699-14

Sponsor Protocol Number: DPM-CF-204

Sponsor Name: Pharmaxis Ltd.

Start Date: 2013-01-28

Medical condition: Cystic fibrosis in children aged 6 to 17 years

Disease:

Version: 14.1

SOC Term: 10010331 – Congenital, familial and genetic disorders

Classification Code: 10011762

Term: Cystic fibrosis

Level: PT

Population Age: Children, Adolescents, Under 18

Gender: Male, Female

Trial Protocol: GB (Ongoing), FR (Completed), BE (Completed), NL (Completed), IT (Completed)

A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to …

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002699-14

Last Update Posted: 04/04/19 05:38AM

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002581-23

EudraCT Number: 2015-002581-23

Sponsor Protocol Number: JBT101-CF-001

Sponsor Name: Corbus Pharmaceuticals, Inc.

Start Date: 2015-12-03

Medical condition: Cystic Fibrosis

Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abno…

Disease:

Version: 18.0

SOC Term: 10010331 – Congenital, familial and genetic disorders

Classification Code: 10011762

Term: Cystic fibrosis

Level: PT

Population Age: Adults

Gender: Male, Female

Trial Protocol: BE (Completed), DE (Completed), FR (Completed), GB (Completed)

A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002581-23

Last Update Posted: 04/03/19 02:45PM