Phase II/III Study of an Alpha-1 Proteinase Inhibitor (Kamada-API) in Individuals With Alpha-1 Antitrypsin Deficiency

Exclusion Criteria

• •1. Laboratory evidence of severe IgA deficiency (from medical history or by IgA testing at screening of at least 20% of lower range).
• •2. Current smoker or a history of smoking within the past 3 months.
• •3. History of allergy to plasma proteins.
• •4. Participation in another experimental drug or device trial within the past 30 days.
• •5. Evidence of uncontrolled hypertension (systolic ≥180 mm Hg, and/or diastolic ≥ 110 mm Hg on 3 consecutive occasions in the supine position)
• •6. Pulse ≥ 120/min (prior to the 1st infusion).
• •7. Abnormal screening or baseline laboratory measurements that in the opinion of the Investigator would affect subject safety.
• •8. Pregnancy or lactation.
• •9. Current life-threatening malignancy.
• •10. Previous organ transplant recipient.
• •11. History of infection with HCV, HBV and/or HIV 1 or 2, or (at baseline) infection indicated by laboratory measurements obtained at screening.
• •12. Acute respiratory tract infection or COPD exacerbation which required antibiotic and/or systemic steroid treatment within the past 6 weeks. Patient can be re-evaluated for enrollment 6 weeks after an exacerbation.
• •13. Any other condition which in the judgment of the investigator may interfere with the conduct of the study.
• •14. If an adequate home health care agency cannot be established by Centric Health Resources due to a potential subject's geographical location.
• •1. FEV1 \< 45% predicted (post-BD).
• •2. Inability to undergo bronchoscopy.
• •3. Allergy to lidocaine.
• •4. Exacerbation of COPD in the previous 6 weeks.