Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

Exclusion Criteria

• •Has received alpha1-PI augmentation therapy for more than 1 month within the six months prior to the Screening Visit.
• •Has received alpha1-PI augmentation therapy within one month of the Screening Visit.
• •Has had a chronic obstructive pulmonary disease (COPD) exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase.
• •Unable to physically (e.g., unable to fit inside the CT scanner) or mentally (e.g., claustrophobic) undergo a CT scan.
• •History of lung or liver transplant.
• •Any lung surgery during the past 2 years (excluding lung biopsy).
• •On the waiting list for lung surgery, including lung transplant.
• •Smoking during the past 12 months or a positive urine cotinine test at screening that is due to smoking. Maybe on Nicotine replacement, including vapor cigarettes.
• •History of anaphylaxis or severe systemic response to any plasma-derived alpha1-PI preparation or other blood product(s).
• •Use of systemic steroids above a stable dose equivalent to 5 mg/day prednisone (i.e., 10 mg every 2 days) within the 5 weeks prior to the Screening Visit (inhaled steroids are not considered systemic steroids) or during the Screening Phase.
• •Use of systemic or aerosolized antibiotics for a COPD exacerbation within the 5 weeks prior to the Screening Visit or during the Screening Phase.
• •Known selective or severe Immunoglobulin A (IgA) deficiency.