299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-003319-21-BE (EUCTR) | 08/11/2018 | 21/08/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | United States;France;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 2 | EUCTR2017-003319-21-DE (EUCTR) | 20/07/2018 | 09/04/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | United States;France;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 3 | EUCTR2017-003319-21-GB (EUCTR) | 04/06/2018 | 03/07/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | France;United States;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 4 | EUCTR2009-014412-35-GB (EUCTR) | 23/02/2010 | 01/10/2009 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS | Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Germany;United Kingdom | |||
| 5 | EUCTR2009-014412-35-DE (EUCTR) | 27/01/2010 | 09/10/2009 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS | Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Germany;United Kingdom | ||
| 6 | EUCTR2008-001530-27-GB (EUCTR) | 11/03/2009 | 18/04/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom;Denmark;Sweden | ||
| 7 | EUCTR2008-001530-27-DK (EUCTR) | 02/02/2009 | 20/11/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom;Denmark;Sweden | ||
| 8 | EUCTR2008-001530-27-SE (EUCTR) | 06/08/2008 | 17/06/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom;Denmark;Sweden | ||
| 9 | EUCTR2008-001530-27-DE (EUCTR) | 08/07/2008 | 26/05/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | United Kingdom;Germany;Denmark;Sweden | ||
| 10 | EUCTR2007-006204-37-GB (EUCTR) | 03/07/2008 | 09/05/2008 | Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF | Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Glutamine Product Code: none Other descriptive name: L-Glutamine | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom |