NCT00462709已完成3 期
LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 146
- 试验地点
- 93
- 主要终点
- Frequency of All HAE Attacks
研究概览
简要总结
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of at least 1 HAE attack per month or any history of laryngeal edema
- •In addition, this study was open to all subjects who:
- •Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
- •Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
- •Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up
- •Were excluded from LEVP2005-1 for any of the following reasons:
- •Pregnancy or lactation
- •Age less than 6 years
- •Narcotic addiction
- •Presence of anti-C1 inhibitor (C1INH) autoantibodies
- •Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:
- •Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
- •Had a known HAE-causing C1INH mutation, or
- •Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator
排除标准
- •History of allergic reaction to C1INH or other blood products
- •Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals
- •Received blood or a blood product in the past 60 days other than C1INH-nf
结局指标
主要结局
Frequency of All HAE Attacks
时间窗: Duration of the study
A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
次要结局
未报告次要终点
研究者
研究点 (93)
Loading locations...
相似试验
已完成
3 期
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) AttacksHereditary AngioedemaNCT00438815Shire113
已完成
3 期
C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) AttacksHereditary AngioedemaNCT01005888Shire26
已完成
3 期
A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary AngioedemaHereditary Angioedema Types I and IINCT02316353CSL Behring126
已完成
3 期
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) AttacksHereditary AngioedemaNCT00289211Shire83
已完成
3 期
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary AngioedemaHereditary Angioedema Types I and IINCT01912456CSL Behring90