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 | EUCTR2016-004033-25-ES (EUCTR) | 19/06/2017 | 31/03/2017 | Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis | Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial | Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10074550;Term: Preventive antimicrobial therapy in cystic fibrosis;System Organ Class: 100000004865 MedDRA version: 20.0;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Sodium bicarbonate INN or Proposed INN: Sodium Bicarbonate Other descriptive name: SODIUM BICARBONATE BP Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: Water for injections INN or Proposed INN: water for injections Other descriptive name: WATER FOR INJECTIONS, EP | Fundació Parc Taulí | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Spain | |||
| 2 | NCT01710644 (ClinicalTrials.gov) | May 2013 | 17/10/2012 | Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Pancreatic Insufficiency;Cystic Fibrosis;Digestive System Diseases;Lung Diseases;Respiratory Tract Diseases | Drug: Burlulipase;Drug: Placebo (Caramel in sterile water) | Nordmark Arzneimittel GmbH & Co. KG | Parexel | Completed | 12 Years | N/A | Both | 35 | Phase 1/Phase 2 | United States |
| 3 | NCT01594827 (ClinicalTrials.gov) | October 2012 | 7/5/2012 | Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP) | Persistent MRSA Eradication Protocol (PMEP) | Cystic Fibrosis | Drug: Inhaled Vancomycin;Drug: Placebo (Sterile Water);Drug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX);Drug: Doxycycline;Drug: Mupirocin Intranasal Creme;Drug: 4% chlorhexidine gluconate liquid skin cleanser | Johns Hopkins University | Case Western Reserve University;Cystic Fibrosis Foundation | Completed | 12 Years | N/A | All | 29 | Phase 2 | United States |
| 4 | 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 | |||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | |||
| 9 | 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 | |||
| 10 | 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 | |||
| 11 | 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 | |||
| 12 | 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 | |||
| 13 | 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 |