Kamada-aat for inhalation    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
231Alpha-1-antitrypsin deficiency11

231. Alpha-1-antitrypsin deficiency    [ 83 clinical trials,   89 drugs,   (DrugBank: 16 drugs),   35 drug target genes,   46 drug target pathways]
Searched query = "Alpha-1-antitrypsin deficiency", "AATD"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
11 / 83 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000602-30-FI
(EUCTR)
08/09/202008/05/2020A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%).A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%). - Phase III, Efficacy and Safety of Kamada-AAT for Inhalation Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%), and with no history of two or more moderate or one or more severe exacerbations of COPD during the past year.
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Kamada -AAT for Inhalation or inhaled AAT (AAT)
INN or Proposed INN: Alpha-1 Antitrypsin (AAT)
Other descriptive name: RECOMBINANT ADENO-ASSOCIATED VIRAL VECTOR EXPRESSING THE HUMAN ALPHA-1-ANTITRYPSIN GENE
Kamada Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3Finland;Belgium;Ireland;Netherlands;United Kingdom;Italy;Sweden
2EUCTR2019-000602-30-GB
(EUCTR)
02/07/202017/03/2020A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%).A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%). - Phase III, Efficacy and Safety of Kamada-AAT for Inhalation Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%), and with no history of two or more moderate or one or more severe exacerbations of COPD during the past year.
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Kamada -AAT for Inhalation or inhaled AAT (AAT)
INN or Proposed INN: Alpha-1 Antitrypsin (AAT)
Kamada Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3Finland;Belgium;Ireland;Netherlands;United Kingdom;Sweden
3EUCTR2019-000602-30-SE
(EUCTR)
29/06/202024/04/2020A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%).A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%). - Phase III, Efficacy and Safety of Kamada-AAT for Inhalation Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 = 80% of predicted; FEV1/SVC = 70%), and with no history of two or more moderate or one or more severe exacerbations of COPD during the past year.
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Kamada -AAT for Inhalation or inhaled AAT (AAT)
INN or Proposed INN: Alpha-1 Antitrypsin (AAT)
Other descriptive name: RECOMBINANT ADENO-ASSOCIATED VIRAL VECTOR EXPRESSING THE HUMAN ALPHA-1-ANTITRYPSIN GENE
Kamada Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3Finland;Argentina;Belgium;Ireland;Netherlands;United Kingdom;Italy;Sweden
4NCT04204252
(ClinicalTrials.gov)
November 25, 201917/12/2019Evaluate Efficacy and Safety of Kamada-AAT for Inhalation in Patients With AATDA Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation 80 mg Per Day in Adult Patients With Congenital Alpha-1 Antitrypsin DeficiencyAlpha 1-Antitrypsin DeficiencyDrug: Alpha 1-Antitrypsin;Drug: PlacebosKamada, Ltd.Syneos HealthRecruiting18 Years65 YearsAll220Phase 3Netherlands
5EUCTR2019-000602-30-NL
(EUCTR)
30/09/201915/05/2019 A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Confirm Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 < 80% of predicted; FEV1/SVC = 70%). A Prospective Phase III Multi-center, Placebo Controlled, Double Blind Study to Confirm Efficacy and Safety of Kamada-AAT for Inhalation” 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 < 80% of predicted; FEV1/SVC = 70%). - Phase III, Efficacy and Safety of Kamada-AAT for Inhalation Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate Airflow Limitation (50% = FEV1 < 80% of predicted; FEV1/SVC = 70%)
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Kamada Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
220Phase 3United States;Canada;Belgium;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT02001688
(ClinicalTrials.gov)
April 201424/11/2013Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for InhalationPhase II, Double-Blind, Placebo-Controlled Study to Explore the ELF and Plasma Concentration as Well as Safety of Inhaled Alpha-1 Antitrypsin in Alpha-1 Antitrypsin Deficiency SubjectsAlpha-1 Antitrypsin DeficiencyDrug: Kamada-AAT for Inhalation, 80mg;Drug: Placebo;Drug: Kamada-AAT for Inhalation, 160mgKamada, Ltd.NULLCompleted18 Years65 YearsAll36Phase 2United States
7EUCTR2008-005326-36-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;Phase 3Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden
8EUCTR2008-005326-36-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;Phase 3Ireland;Denmark;Netherlands;Germany;United Kingdom;Sweden
9EUCTR2008-005326-36-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;Phase 3Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden
10EUCTR2008-005326-36-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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2;Phase 3Ireland;Denmark;Germany;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-005326-36-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