Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 27
- 试验地点
- 6
- 主要终点
- PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.
研究概览
简要总结
The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in LEVP2005-1 (current or in the past)
排除标准
- •C1 inhibitor infusion within the last 7 days
- •Signs of any HAE attack
- •HAE attack within 7 days before actual infusion of C1INH-nf
- •Change in the dosage of androgens in the last 14 days before the study
- •Use of antifibrinolytics in the last 7 days before the study
- •Change in oral conceptive medication in the last two months before the study
- •History of clinically relevant antibody development to C1 inhibitor
- •Use of oral anticoagulant medication in the last 14 days
- •Use of heparin within the last two days prior to the study
- •History of allergic reaction to C1 inhibitor or other blood products
- •Current participation (or within the past 90 days) in any investigational drug study other than those sponsored by Lev Pharmaceuticals
- •Pregnancy or lactation
- •B-cell malignancy
- •Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
研究组 & 干预措施
Single Dose
1,000 Units (U) of C1INH-nf administered intravenously (IV).
干预措施: C1 esterase inhibitor [human] (C1INH-nf) (Drug)
First Dose Followed by Second Dose
1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later.
干预措施: C1 esterase inhibitor [human] (C1INH-nf) (Drug)
结局指标
主要结局
PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.
时间窗: 1 week
C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation.
时间窗: 1 week
次要结局
- Number and severity of adverse events.(3 months)
- Change in clinical laboratory safety parameters from pre- to post-infusion.(3 months)
- Change in vital signs from pre- to post-infusion.(30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose))