231. α1−アンチトリプシン欠乏症 Alpha-1-antitrypsin deficiency Clinical trials / Disease details
臨床試験数 : 93 / 薬物数 : 77 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 36
| 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 | EUCTR2008-005326-36-SE (EUCTR) | 06/10/2011 | 11/09/2009 | A clinical trial looking at the safety and effectiveness of a new drug for inhalation, looking to treat Alpha-1 Antitrypsin Deficient Patients with Emphysema. | A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema | Alpha-1 Antitrypsin deficiency in patients with emphysema. MedDRA version: 17.0;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerosolized human Alpha-1 Antitrypsin Product Code: Kamada-AAT for inhalation Other descriptive name: ALPHA-1-ANTITRYPSIN | Kamada Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 2 | EUCTR2008-005326-36-DE (EUCTR) | 01/10/2010 | 28/04/2010 | A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema | A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema | Alpha-1 Antitrypsin deficiency in patients with emphysema. MedDRA version: 15.1;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerosolized human Alpha-1 Antitrypsin Product Code: Kamada-AAT for inhalation Other descriptive name: ALPHA-1-ANTITRYPSIN | Kamada Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Ireland;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 3 | EUCTR2008-005326-36-IE (EUCTR) | 09/07/2010 | 12/05/2010 | A clinical trial looking at the safety and effectiveness of a new drug for inhalation, looking to treat Alpha-1 Antitrypsin Deficient Patients with Emphysema. | A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema | Alpha-1 Antitrypsin deficiency in patients with emphysema. MedDRA version: 17.0;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerosolized human Alpha-1 Antitrypsin Product Code: Kamada-AAT for inhalation Other descriptive name: ALPHA-1-ANTITRYPSIN | Kamada Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2/3 | Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 4 | EUCTR2008-005326-36-NL (EUCTR) | 05/02/2010 | 21/08/2009 | A clinical trial looking at the safety and effectiveness of a new drug forinhalation, looking to treat Alpha-1 Antitrypsin Deficient Patients withEmphysema. | A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema | Alpha-1 Antitrypsin deficiency in patients with emphysema. MedDRA version: 17.1;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerosolized human Alpha-1 Antitrypsin Product Code: Kamada-AAT for inhalation Other descriptive name: ALPHA-1-ANTITRYPSIN | Kamada Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 5 | EUCTR2008-005326-36-DK (EUCTR) | 13/01/2010 | 14/09/2009 | A clinical trial looking at the safety and effectiveness of a new drug forinhalation, looking to treat Alpha-1 Antitrypsin Deficient Patients withEmphysema. | A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema | Alpha-1 Antitrypsin deficiency in patients with emphysema. MedDRA version: 17.0;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerosolized human Alpha-1 Antitrypsin Product Code: Kamada-AAT for inhalation Other descriptive name: ALPHA-1-ANTITRYPSIN | Kamada Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2;Phase 3 | Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 6 | EUCTR2008-005326-36-GB (EUCTR) | 02/11/2009 | 07/08/2009 | A clinical trial looking at the safety and effectiveness of a new drug for inhalation, looking to treat Alpha-1 Antitrypsin Deficient Patients with Emphysema. | A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema | Alpha-1 Antitrypsin deficiency in patients with emphysema. MedDRA version: 17.0;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Aerosolized human Alpha-1 Antitrypsin Other descriptive name: ALPHA-1-ANTITRYPSIN | Kamada Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden |