NCT01253382撤回2 期
A 3-Part Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Subcutaneous Ecallantide in Prepubertal Paediatric Patients Experiencing Acute Attacks of Hereditary Angioedema (HAE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Shire
- 主要终点
- safety and tolerability of ecallantide
研究概览
简要总结
The primary objective of this study is:
- assess the safety and tolerability of ecallantide in paediatric patients for acute attacks of HAE
The secondary objectives are:
- evaluate the pharmacokinetic profile of ecallantide in paediatric patients treated for acute attacks of HAE
- assess the efficacy of ecallantide in paediatric patients treated for moderate to severe acute attacks of HAE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female from 2 years of age and prepubertal
- •Physician diagnosis and history of HAE (Type I or II) including laboratory results showing C1-1NH activity below the lower limit of normal or up to 15% above the lower limit of the normal range
- •Present at the site with moderate to severe signs and symptoms of an acute attack of HAE within 8 hours of recognition of the onset of the attack. Spontaneous resolution of the attack must not have begun before the administration of study drug.
- •Must have signed informed consent by parent or caregiver.
排除标准
- •<2 years of age or have reached puberty
- •Received treatment with ecallantide within previous 72 hours
- •Received an investigational drug or device, other than ecallantide, within 30 days prior to the screening visit
- •Pharyngeal/laryngeal symptoms
- •Mild attacks including mild edema of the extremities and mild abdominal attacks
- •Are unable or unwilling to give informed consent (parent or caregiver)
- •Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study
结局指标
主要结局
safety and tolerability of ecallantide
时间窗: 4 years
次要结局
- evaluate the PK profile of ecallantide(4 years)
- assess the efficacy of ecallantide(4 years)
研究者
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