Aerosolized human Alpha-1 Antitrypsin ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
231α1−アンチトリプシン欠乏症6

231. α1−アンチトリプシン欠乏症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-005326-36-SE
(EUCTR)
06/10/201111/09/2009A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden
2EUCTR2008-005326-36-DE
(EUCTR)
01/10/201028/04/2010A 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 EmphysemaA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Ireland;Denmark;Netherlands;Germany;United Kingdom;Sweden
3EUCTR2008-005326-36-IE
(EUCTR)
09/07/201012/05/2010A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 2/3Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden
4EUCTR2008-005326-36-NL
(EUCTR)
05/02/201021/08/2009A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden
5EUCTR2008-005326-36-DK
(EUCTR)
13/01/201014/09/2009A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 2;Phase 3Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden
6EUCTR2008-005326-36-GB
(EUCTR)
02/11/200907/08/2009 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 LimitedNULLNot 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): noIreland;Denmark;Germany;Netherlands;United Kingdom;Sweden