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

Completed · Phase 2

Conditions studied: Hereditary Angioedema (HAE)

In brief

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.

Key facts

Study ID

NCT01095510

Run by

Shire

People needed

9

Starts

2010-06-02

Expected to finish

2012-04-17

Last updated by the study team

2021-06-03

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for this protocol, subjects must:
• Be at least 10 kg of body weight.
• Have a confirmed diagnosis of HAE.
• Have an acute HAE attack and be able to initiate treatment within 8 hours after onset of symptoms.

You may not qualify if…

• To be eligible for this protocol, subjects must not:
• Have any active infectious illness.
• Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to dosing with study drug.
• 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.
• Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of the components of CINRYZE), or other blood products.
• 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.

Where it is running

• Asthma & Allergy Associates, P.C. — Colorado Springs, Colorado, United States
• University of South Florida Asthma, Allergy and Immunology Clinical Research Unit — Tampa, Florida, United States
• Institute for Asthma and Allergy, PC — Chevy Chase, Maryland, United States
• Allergy & Asthma Research Group — Eugene, Oregon, United States
• Baker Allergy, Asthma and Dermatology Research Center, LLC — Lake Oswego, Oregon, United States
• AARA Research Center — Dallas, Texas, United States
• Allergy and Asthma Research Center, P.A. — San Antonio, Texas, United States
• Marycliff Allergy Specialists — Spokane, Washington, United States
• Charité Universitätsmedizin Berlin, Dept. of Dermatology and Allergy — Berlin, Germany
• Klinikum rechts der Isar, Technical University Munich, ENT Clinic — Munich, Germany
• Semmelweis University, Allergy and Angioedema Outpatients Clinic, Kútvölgyi Clinical Center — Budapest, Hungary

Full record on ClinicalTrials.gov

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