Open-label Extension Study of CE1145 (Human Pasteurized C1 Esterase Inhibitor Concentrate) in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)
研究概览
简要总结
Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented congenital C1-INH deficiency
- •Acute HAE attack
- •Participation in base study CE1145_3001 (NCT00168103)
排除标准
- •Acquired angioedema
- •Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry
研究组 & 干预措施
C1 Esterase Inhibitor
干预措施: C1 Esterase Inhibitor (Drug)
结局指标
主要结局
Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)
时间窗: Up to 24 h after start of study treatment
The start of symptom relief was determined by subject self-assessment.
Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)
时间窗: Up to 24 h after start of study treatment
The start of symptom relief was determined by subject self-assessment.
次要结局
- Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)(Up to Day 9 following an attack)
- Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)(Up to Day 9 following an attack)