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Keep this study
Lead
Shire
Each subject received CINRYZE for treatment of a single acute angioedema attack.
Age
2–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
To be eligible for this protocol, subjects must:
1. Be at least 10 kg of body weight.
2. Have a confirmed diagnosis of HAE.
3. Have an acute HAE attack and be able to initiate treatment within 8 hours after onset of symptoms.
You may not be if
To be eligible for this protocol, subjects must not:
1. Have any active infectious illness.
2. Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to dosing with study drug.
3. Have received therapy with antifibrinolytics (e.g., tranexamic acid), androgens (e.g., danazol, oxandrolone, stanozolol, or testosterone), ecallantide (Kalbitor®), or icatibant (Firazyr®) within 7 days prior to dosing with study drug.
4. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of the components of CINRYZE), or other blood products.
5. Have participated in any other investigational drug evaluation within 30 days prior to dosing with study drug, or have previously received treatment with CINRYZE in this study at any time.
Clareo Health | CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
