CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12



Status:Completed
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:2 - 11
Updated:12/14/2018
Start Date:June 2, 2010
End Date:April 17, 2012

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Open-Label, Single-Dose Study to Evaluate the Response and Pharmacokinetics/Pharmacodynamics of Different Doses of CINRYZE® [C1 Inhibitor (Human)] For Treatment of Acute Angioedema Attacks in Children Less Than 12 Years of Age With Hereditary Angioedema

The objectives of this study were to evaluate: (1) the dose response and (2) the
pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE
for the treatment of acute angioedema attacks in children above and below 25 kg and less than
12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and
tolerability following IV administration of CINRYZE in this study population.

Each subject received CINRYZE for treatment of a single acute angioedema attack.

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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Berlin,
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Chevy Chase, Maryland 20815
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Colorado Springs, Colorado 80907
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Colorado Springs, CO
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Dallas, Texas 75231
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Eugene, Oregon 97401
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Eugene, OR
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Lake Oswego, OR
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San Antonio, Texas 78229
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San Antonio, TX
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Spokane, Washington 99204
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Spokane, WA
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Tampa, FL
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