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

  
9 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2006-006693-24-CZ
(EUCTR)
16/07/200809/05/2007A 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 FibrosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
2EUCTR2006-006693-24-ES
(EUCTR)
21/01/200814/09/2007Estudio 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 - MOLIEstudio 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 AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
3EUCTR2006-006693-24-DE
(EUCTR)
29/08/200729/05/2007A 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 FibrosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
4EUCTR2006-006693-24-SE
(EUCTR)
16/08/200702/07/2007A 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 FibrosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
5EUCTR2006-006693-24-HU
(EUCTR)
27/07/200718/06/2007A 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 FibrosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
6EUCTR2006-006693-24-AT
(EUCTR)
09/05/200711/01/2007A 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 FibrosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
7EUCTR2005-004344-30-HU
(EUCTR)
10/05/200623/12/2005An 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 DiseaseAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary
8EUCTR2005-004344-30-AT
(EUCTR)
31/10/200526/09/2005An 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 DiseaseAn 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 AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary;Austria
9EUCTR2006-006693-24-PL
(EUCTR)
11/10/2007A 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 FibrosisA 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 AGNULLNAFemale: yes
Male: yes
160Phase 2France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden