NCT01095497已完成2 期
An Open-Label Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Versus Intravenous (IV) Administration of CINRYZE in Adolescents and Adults With Hereditary Angioedema (HAE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 26
- 试验地点
- 14
- 主要终点
- Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.
研究概览
简要总结
The objectives of the study are to:
- Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema
- Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection
- Assess the immunogenicity of CINRYZE following subcutaneous administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for this protocol, a subject must:
- •Have a confirmed diagnosis of HAE.
- •During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) treated with C1INH therapy or any other blood products, ecallantide (Kalbitor), icatibant (Firazyr), antifibrinolytics (e.g., tranexamic acid), IV fluids, or narcotic analgesics.
- •Agree to strictly adhere to the protocol-defined schedule of assessments and procedures.
排除标准
- •To be eligible for this protocol, a subject must not:
- •Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose.
- •Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose.
- •Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose.
- •If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose.
- •Have a history of abnormal blood clotting or other coagulopathy.
- •Have a history of allergic reaction to CINRYZE or other blood products.
- •Be pregnant or breastfeeding.
- •Have received an immunization within 30 days prior to the first dose.
- •Have participated in any other investigational drug study within 30 days prior to the first dose.
结局指标
主要结局
Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.
时间窗: 18 days in each treatment period
次要结局
- Mean Change C1 Inhibitor (C1INH)(18 days in each treatment period)
- Mean Change C4 Compliment(18 days in each treatment period)
- Number of Participants With C1 Inhibitor (INH) Antibodies(18 days in each treatment period)
研究者
研究点 (14)
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