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 (Protocol 0624-203).

ViroPharma Incorporated0 个研究点目标入组 12 人开始时间: 2011年8月30日最近更新: 2013年10月14日

试验速览

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•1. Be children (male or female), =2 and <12 years of age.
•2. Be at least 10 kg of body weight.
•3. Have a confirmed diagnosis of HAE with at least one of the following:
•- C1 inhibitor (C1 INH) antigen level below normal
•- Functional C1 INH level below normal
•4. Have an acute HAE attack and be able to initiate study drug treatment within 8 hours after onset of symptoms.
•5. Have a parent/legal guardian who is willing and able to provide written informed consent for the child to participate in the study (with assent from the child when appropriate).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 12
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Have any active infectious illness (e.g., flu, upper respiratory tract infection, etc.).
•2. Have had a prior HAE attack within 7 days prior to dosing with study drug and/or received any C1 INH product for the treatment or prevention of an HAE attack 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.
•6. Have, as determined by the investigator and/or the sponsor’s medical monitor, any surgical or medical condition that could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.
•7. If female, be pregnant or breastfeeding.
•8. Be suspected of having an alternate explanation for their symptoms other than acute HAE attack.
•9. Have a history of narcotic-seeking behavior and/or drug/alcohol abuse.

发起方