A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

Inclusion criteria

To be eligible for this protocol, a subject must:

• Provide informed consent/assent, as appropriate.
• Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study.
• During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) that required treatment with C1 INH therapy or other blood products.
• Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.

Exclusion criteria

To be eligible for this protocol, a subject must not:

• Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
• Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
• Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug.
• If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
• Have a history of abnormal blood clotting.
• Have a history of allergic reaction to products containing C1 INH or other blood products.
• Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.
• Be pregnant or breastfeeding.
• Have received an investigational study drug within 30 days prior to the first dose of study drug.