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 | EUCTR2011-000801-39-ES (EUCTR) | 25/07/2014 | 25/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens? eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Belgium;Spain;Ireland;Austria;Germany;Italy;Sweden | ||
| 2 | EUCTR2011-000801-39-AT (EUCTR) | 11/06/2014 | 24/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 3 | EUCTR2011-000801-39-HU (EUCTR) | 22/05/2014 | 03/04/2014 | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 4 | EUCTR2011-000801-39-IE (EUCTR) | 07/05/2013 | 12/02/2013 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 5 | EUCTR2011-000801-39-IT (EUCTR) | 20/06/2012 | 21/06/2012 | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | MUKOVISZIDOSE E.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 6 | EUCTR2011-000801-39-BE (EUCTR) | 26/04/2012 | 09/01/2012 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 7 | EUCTR2011-000801-39-SE (EUCTR) | 08/02/2012 | 13/12/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 8 | NCT01455675 (ClinicalTrials.gov) | October 2011 | 18/10/2011 | Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients | Phase III Study to Evaluate Clinical Efficacy and Safety of Avian Polyclonal Anti-Pseudomonas Antibodies (IgY) in Prevention of Recurrence of Pseudomonas Aeruginosa Infection in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: IgY;Drug: Placebo | Mukoviszidose Institut gGmbH | NULL | Completed | 5 Years | N/A | All | 164 | Phase 3 | Austria;Belgium;Germany;Hungary;Ireland;Italy;Poland;Spain;Sweden |
| 9 | EUCTR2011-000801-39-DE (EUCTR) | 31/08/2011 | 04/04/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 10 | NCT00633191 (ClinicalTrials.gov) | November 2003 | 4/3/2008 | Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis | Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients | Cystic Fibrosis;Infection;Pseudomonas Aeruginosa | Drug: Anti-pseudomonas IgY gargle | Immunsystem AB | NULL | Completed | N/A | N/A | Both | 14 | Phase 1/Phase 2 | Sweden |