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 | EUCTR2006-006693-24-CZ (EUCTR) | 16/07/2008 | 09/05/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 2 | EUCTR2006-006693-24-IT (EUCTR) | 31/01/2008 | 12/11/2007 | A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND | A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND | Cystic fibrosis MedDRA version: 6.1;Level: PT;Classification code 10011763 | Product Name: DURAMYCIN Product Code: MOLI 1901 | AOP ORPHAN PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 3 | EUCTR2006-006693-24-ES (EUCTR) | 21/01/2008 | 14/09/2007 | Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLI | Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLI | La FQ es la enfermedad hereditaria mortal más frecuente en la población caucásica, afectando a unos 4 de cada 10.000 niños. En la fibrosis quística, el transporte de cloro a través del epitelio respiratorio es deficiente, de manera que la mucosidad contiene menos agua y su viscosidad está aumentada de manera anormal. Se puede suponer que Moli1901 corrige el transporte anormal de cloro y agua en los pulmones y de ese modo reduce la formación de tapones de mucosidad y aumenta el aclaramiento. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2;Phase 3 | France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden | ||
| 4 | EUCTR2006-006693-24-DE (EUCTR) | 29/08/2007 | 29/05/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2;Phase 3 | France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden | ||
| 5 | EUCTR2006-006693-24-FR (EUCTR) | 23/08/2007 | 16/05/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In Cystic Fibrosis chloride transport accross the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli 1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. | Product Name: Moli 1901 (2622U90, duramycin) Product Code: Moli 1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2;Phase 3 | France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden | ||
| 6 | EUCTR2006-006693-24-SE (EUCTR) | 16/08/2007 | 02/07/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 7 | EUCTR2006-006693-24-HU (EUCTR) | 27/07/2007 | 18/06/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 8 | EUCTR2006-006693-24-AT (EUCTR) | 09/05/2007 | 11/01/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 9 | EUCTR2005-005594-29-HU (EUCTR) | 31/10/2006 | 19/06/2006 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic Fibrosis | Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2;Phase 3 | Czech Republic;Hungary;Slovakia | ||
| 10 | EUCTR2005-005594-29-CZ (EUCTR) | 04/10/2006 | 02/08/2006 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic Fibrosis | Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2;Phase 3 | Hungary;Czech Republic;Slovakia | ||
| 11 | EUCTR2005-005594-29-SK (EUCTR) | 14/09/2006 | 11/08/2006 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic Fibrosis | Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2;Phase 3 | Czech Republic;Hungary;Slovakia | ||
| 12 | EUCTR2005-004344-30-HU (EUCTR) | 10/05/2006 | 23/12/2005 | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance. | Product Name: Moli1901 (2622U90, duramycin) Product Code: EU Orphan Designation Number EU/3/02/120 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Hungary | |||
| 13 | EUCTR2005-004344-30-AT (EUCTR) | 31/10/2005 | 26/09/2005 | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance. | Product Name: Moli1901 (2622U90, duramycin) Product Code: EU Orphan Designation Number EU/3/02/120 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Hungary;Austria | |||
| 14 | EUCTR2006-006693-24-PL (EUCTR) | 11/10/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin | AOP Orphan Pharmaceuticals AG | NULL | NA | Female: yes Male: yes | 160 | Phase 2 | France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden |