A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CINRYZE with rHuPH20
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: HAE; C1 esterase inhibitor; C1 INH; Subcutaneous; hyaluronidase; rHuPH20

Summary:

      The objectives of the study are to:

        1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with
           recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE)
           who previously participated in CINRYZE Study 0624-200 (NCT01095497)

        2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered
           CINRYZE with rHuPH20

        3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of
           CINRYZE with rHuPH20
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for this protocol, a subject must:

          1. Provide informed consent/assent, as appropriate.

          2. Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous
             therapy period in that study.

          3. 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.

          4. 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:

          1. 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.

          2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics
             (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.

          3. 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.

          4. 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.

          5. Have a history of abnormal blood clotting.

          6. Have a history of allergic reaction to products containing C1 INH or other blood
             products.

          7. Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.

          8. Be pregnant or breastfeeding.

          9. Have received an investigational study drug within 30 days prior to the first dose of
             study drug.