NCT01426763已完成2 期
An Open-label Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) in Subjects 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
- 12
- 试验地点
- 5
- 主要终点
- Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants 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 subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497)
- Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20
- Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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:
- •Provide informed consent/assent, as appropriate.
- •Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study.
- •During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) that required treatment with C1 INH therapy or other blood products.
- •Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.
排除标准
- •To be eligible for this protocol, a subject must not:
- •Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
- •Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
- •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 of study drug.
- •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 of study drug.
- •Have a history of abnormal blood clotting.
- •Have a history of allergic reaction to products containing C1 INH or other blood products.
- •Have a known allergy to hyaluronidase or any other ingredient in rHuPH
- •Be pregnant or breastfeeding.
- •Have received an investigational study drug within 30 days prior to the first dose of study drug.
结局指标
主要结局
Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study
时间窗: 18 days
次要结局
- Number of Subjects With C1 INH Antibodies(Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4))
- Mean Change C1 Inhibitor (C1INH)(18 days)
- Mean Change C4 Compliment(18 days)
研究者
研究点 (5)
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