EDEMA2: An Open-Label Study to Assess the Efficacy and Tolerability of Repeated Doses of DX-88 (Recombinant Plasma Kallikrein Inhibitor) in Patients With Hereditary Angioedema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 77
- 主要终点
- Proportion of attacks treated with successful outcome
研究概览
简要总结
EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 years of age or older
- •Documented diagnosis of HAE (Type I or II)
- •Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack
- •Willing and able to give informed consent
排除标准
- •Patients with a serious intercurrent illness or serious active infection
- •Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal
- •Receipt of an investigational drug or device, within 30 days prior to study treatment
- •Pregnancy or breastfeeding
- •Diagnosis of acquired angioedema (AAE)
- •Patients who had not completed their Day-7 follow-up procedures for a previously treated attack
研究组 & 干预措施
30 mg DX-88 SC
30mg DX-88(ecallantide)administered subcutaneously
干预措施: DX-88 (ecallantide) (Drug)
5mg/m2 DX-88 IV
5mg/m2 DX-88 (ecallantide)administered intravenously
干预措施: DX-88 (ecallantide) (Drug)
10mg/m2 DX-88 IV
10mg/m2 DX-88(ecallantide)administered intravenously
干预措施: DX-88 (ecallantide) (Drug)
20mg/m2 DX-88 IV
20mg/m2 DX-88 (ecallantide) administered intravenously
干预措施: DX-88 (ecallantide) (Drug)
结局指标
主要结局
Proportion of attacks treated with successful outcome
时间窗: 24 hours
successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours
Proportion of attacks with a partial response
时间窗: 24 hours
partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours
次要结局
- Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response(24 hours)
- Time to resolution onset of each acute attack, as determined by patient report(24 hours)