NCT01095510已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 9
- 试验地点
- 19
- 主要终点
- Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom
研究概览
简要总结
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.
详细描述
Each subject received CINRYZE for treatment of a single acute angioedema attack.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom
时间窗: Within 4 hours following treatment
次要结局
- Time to Unequivocal Beginning of Relief of the Defining Attack Symptom(Within 4 hours following treatment)
- Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations(Pre-dose, 2, 4, 8 hours post dose on Day 1; Day 2, 3, 5, 8)
- Time to Complete Resolution of the Attack(Within 1 week following treatment)
研究者
研究点 (19)
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