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 | EUCTR2015-004143-39-ES (EUCTR) | 19/04/2017 | 31/03/2017 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.1;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: Hypertonic saline INN or Proposed INN: HYPERTONIC SALINE Other descriptive name: SALINE Product Name: Isotonic saline INN or Proposed INN: ISOTONIC SALINE Other descriptive name: STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V) | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Denmark;Australia;Netherlands | ||
| 2 | EUCTR2015-004841-13-CZ (EUCTR) | 04/01/2017 | 10/08/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 3 | EUCTR2015-004841-13-IE (EUCTR) | 08/08/2016 | 07/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic Saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 4 | EUCTR2015-004841-13-GB (EUCTR) | 20/07/2016 | 09/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | 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] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 5 | NCT02141191 (ClinicalTrials.gov) | June 2014 | 12/5/2014 | A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD Device | A Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: inhaled hypertonic saline (7%) | University of Pittsburgh | Parion Sciences | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 6 | NCT01417481 (ClinicalTrials.gov) | March 2012 | 15/8/2011 | Effect of Glycine in Cystic Fibrosis | Evaluation of the Capability of a Glycine Oral Supplement for Diminishing Bronchial Inflammation in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Glycine;Dietary Supplement: Placebo | Instituto Nacional de Enfermedades Respiratorias | Hospital Infantil de Mexico Federico Gomez;Instituto Mexicano del Seguro Social | Terminated | 5 Years | 15 Years | All | 13 | Phase 2 | Mexico |
| 7 | EUCTR2010-018454-13-DK (EUCTR) | 27/10/2010 | 13/08/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2010-018454-13-ES (EUCTR) | 06/09/2010 | 31/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado | Cystic fibrosisFibrosis quistica MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Belgium;Spain;Denmark;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2010-018454-13-GB (EUCTR) | 01/09/2010 | 18/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;Germany;United Kingdom;France;Spain;Italy | ||
| 10 | EUCTR2010-018454-13-DE (EUCTR) | 31/08/2010 | 21/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 11 | EUCTR2010-018454-13-CZ (EUCTR) | 27/08/2010 | 21/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;United Kingdom;Germany;Czech Republic;France;Spain;Italy | ||
| 12 | EUCTR2010-018454-13-HU (EUCTR) | 17/08/2010 | 17/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 13 | EUCTR2010-018454-13-FR (EUCTR) | 10/08/2010 | 28/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | ||
| 14 | EUCTR2010-018454-13-IT (EUCTR) | 15/07/2010 | 15/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011762 | Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N acetylcysteinate Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N-acetylcysteinate | LABORATOIRES SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 15 | NCT00809094 (ClinicalTrials.gov) | November 2008 | 15/12/2008 | NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients | A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients | Cystic Fibrosis | Drug: N-acetylcysteine (NAC);Drug: Placebo | Stanford University | Cystic Fibrosis Foundation Therapeutics | Completed | 7 Years | N/A | All | 70 | Phase 2 | United States |
| 16 | NCT00274391 (ClinicalTrials.gov) | July 2001 | 9/1/2006 | Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis | Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis | Cystic Fibrosis | Drug: 7% NaCl;Drug: Amiloride HCl | University of North Carolina | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 24 | Phase 2 | United States |
| 17 | EUCTR2015-004841-13-FR (EUCTR) | 23/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Czech Republic;Ireland;United Kingdom | |||
| 18 | EUCTR2010-018454-13-BE (EUCTR) | 25/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy |