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This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha-1 MP 60 mg/kg | Experimental | Alpha-1 MP 60 mg/kg administered weekly by IV infusion for 156 weeks |
|
| Alpha-1 MP 120 mg/kg | Experimental | Alpha-1 MP 120 mg/kg administered weekly by IV infusion for 156 weeks |
|
| Placebo | Placebo Comparator | 0.9% Sodium Chloride for Injection, USP, administered weekly by IV infusion for 156 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha-1 MP | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Whole lung PD15 (15th percentile point) | Whole lung PD15 measured by CT scan | Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) | Monitoring of AEs | Week -3 through Week 160 |
| Serious Adverse Events (SAEs) | Monitoring of SAEs | Week -3 through Week 160 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grifols Investigative Site | Phoenix | Arizona | 85013 | United States | ||
| Grifols Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25727857 | Derived | Sorrells S, Camprubi S, Griffin R, Chen J, Ayguasanosa J. SPARTA clinical trial design: exploring the efficacy and safety of two dose regimens of alpha1-proteinase inhibitor augmentation therapy in alpha1-antitrypsin deficiency. Respir Med. 2015 Apr;109(4):490-9. doi: 10.1016/j.rmed.2015.01.022. Epub 2015 Feb 13. |
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| 0.9% Sodium Chloride for Injection, USP |
| Other |
|
|
| Discontinuations from the study due to AEs | Monitoring of discontinuations due to AEs | Week -3 through Week 160 |
| Severe COPD Exacerbations | Severe COPD exacerbations as defined by American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (i.e., COPD exacerbations requiring hospitalization) | Week -3 through Week 160 |
| Change from Baseline in PD15 of the basal lung region | PD15 of the basal lung region measure by CT scan | Week -3 (baseline measure), Week 52, Week 104, Week 130, Week 156 |
| Change from baseline in carbon monoxide diffusing capacity (DLco) | DLco performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines | Weeks 26, 52, 78, 104, 130 and 156 |
| Changes from baseline in forced expiratory volume in 1 second (FEV1) | FEV1 performed according to ATS/ERS guidelines | Weeks 26, 52, 78, 104, 130 and 156 |
| Change from baseline in Saint George's Respiratory Questionnaire: Minimum value = 0, maximum value = 100, higher scores indicate worse condition | Health-related quality of life assessment tool | Weeks 26, 52, 78, 104, 130 and 156 |
| Change from baseline in the EuroQoL (Quality of Life)- 5 Dimension- 5 Level (EQ-5D-5L): Minimum value (for each one of the 5 levels) = 1, maximum value (for each one of the 5 levels) = 5, higher scores indicate worse condition | Heath-related quality of life assessment tool | Weeks 26, 52, 78, 104, 130 and 156 |
| Gainesville |
| Florida |
| 32610 |
| United States |
| Grifols Investigative Site | Leesburg | Florida | 34748 | United States |
| Grifols Investigative Site | Miami | Florida | 33136 | United States |
| Grifols Investigative Site | St Louis | Missouri | 63110 | United States |
| Grifols Investigative Site | Wilmington | North Carolina | 28401 | United States |
| Grifols Investigative Site | Portland | Oregon | 97239 | United States |
| Grifols Investigative Site | Hershey | Pennsylvania | 17033 | United States |
| Grifols Investigative Site | Charleston | South Carolina | 29425 | United States |
| Grifols Investigative Site | Tyler | Texas | 75708 | United States |
| Grifols Investigative Site | Vicente López | Buenos Aires | B1602DOH | Argentina |
| Grifols Investigative Site | Córdoba | Córdoba Province | 5000 | Argentina |
| Grifols Investigative Site | Sydney | New South Wales | 2010 | Australia |
| Grifols Investigative Site | Chermside | Queensland | 4032 | Australia |
| Grifols Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Grifols Investigative Site | Fitzroy | Victoria | 3065 | Australia |
| Grifols Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Grifols Investigative Site | Santo André | São Paulo | 09060-650 | Brazil |
| Grifols Investigative Site | São Paulo | São Paulo | 04023-061 | Brazil |
| Grifols Investigative Site | São Paulo | São Paulo | 05403-000 | Brazil |
| Grifols Investigative Site | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Grifols Investigative Site | Halifax | Nova Scotia | B3H3A8 | Canada |
| Grifols Investigative Site | Toronto | Ontario | M5T3A11 | Canada |
| Grifols Investigative Site | Arhus C | 8000 | Denmark |
| Grifols Investigative Site | Hellerup | 2900 | Denmark |
| Grifols Investigative Site | Tallinn | 13419 | Estonia |
| Grifols Investigative Site | Tartu | 51014 | Estonia |
| Grifols Investigative Site | Turku | 20520 | Finland |
| Grifols Investigative Site | Pessac | Gironde | 33604 | France |
| Grifols Investigative Site | Bron | Rhone | 69500 | France |
| Grifols Investigative Site | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Grifols Investigative Site | Marburg | Hesse | 35043 | Germany |
| Grifols Investigative Site | Essen | North Rhine-Westphalia | 45239 | Germany |
| Grifols Investigative Site | Homburg Saar | 66421 | Germany |
| Grifols Investigative Site | Chisinau | 2025 | Moldova |
| Grifols Investigative Site | Auckland | 1051 | New Zealand |
| Grifols Investigative Site | Christchurch | 8013 | New Zealand |
| Grifols Investigative Site | Hamilton | 3240 | New Zealand |
| Grifols Investigative Site | Krakow | 31-066 | Poland |
| Grifols Investigative Site | Warsaw | 01-138 | Poland |
| Grifols Investigative Site | Oradea | 410176 | Romania |
| Grifols Investigative Site | Timișoara | 300312 | Romania |
| Grifols Investigative Site | Barnaul | 656038 | Russia |
| Grifols Investigative Site | Moscow | 105077 | Russia |
| Grifols Investigative Site | Yaroslavl | 150003 | Russia |
| Grifols Investigative Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Grifols Investigative Site | Barakaldo | Vizcaya | 48903 | Spain |
| Grifols Investigative Site | Gothenburg | 41345 | Sweden |
| Grifols Investigative Site | Linköping | 587 58 | Sweden |
| Grifols Investigative Site | Malmö | 20502 | Sweden |
| Grifols Investigative Site | Stockholm | 11361 | Sweden |
| Grifols Investigative Site | Uppsala | 752 37 | Sweden |
| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| D019896 | alpha 1-Antitrypsin Deficiency |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013352 | Subcutaneous Emphysema |
| D004646 | Emphysema |
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| ID | Term |
|---|---|
| C114276 | Mp alpha1 receptor |
| D012965 | Sodium Chloride |
| D007267 | Injections |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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