Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

Exclusion Criteria

• •Any relevant chronic diseases or history of relevant diseases (e.g., severe renal insufficiency) except respiratory or liver disease secondary to alpha1-proteinase inhibitor deficiency. Subjects with well-controlled, chronic diseases may be included after consultation with the treating physician and the sponsor.
• •Current evidence of alcohol abuse or history of abuse of illegal and/or legally prescribed drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids.
• •History of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol.
• •History of transfusion reactions.
• •Selective IgA deficiency.
• •Acute illness within one week prior to the first administration of the investigational medicinal product (IMP). Start of treatment after recovery is possible.
• •Current tobacco smoker (smoking has to be ceased at least 6 months prior study inclusion). Subjects with a positive cotinine test due to nicotine replacement therapy (e.g. patches, chewing gum) or snuff are eligible.
• •Conditions or behaviors that interfere with attending scheduled study visits in the opinion of the investigator.
• •History of non-compliance.
• •Administration of any other experimental new drug or participation in an investigation of a marketed product within one month prior to the screening visit date.
• •Inability to perform necessary study procedures.
• •Lung transplantation, lung volume reduction surgery or lobectomy or being on a waiting list for any such surgeries.