Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I.
研究概览
简要总结
The investigators will conduct a double-blind, randomized controlled trial comparing the safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design will be used such that patients failing to improve on standard therapy will additionally be treated with ecallantide. Therefore, a historical control cohort will be enrolled for analysis of secondary endpoints. In addition, since some patients treated with conventional therapy may improve rapidly and therefore not be eligible for inclusion in the study, the investigators will enroll these patients as an observational arm to enable the conduct of sensitivity analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females of any race or ethnicity 18 or older. The locations of the study will permit all racial and ethnic distribution in the study
- •Must currently be on an ACE inhibitor
- •Presenting with ACE induced angioedema within 12 hours after onset. This is to be documented in the source document and CRF
- •All females of childbearing age must have a negative pregnancy test prior to administration of the study drug.
排除标准
- •Participation in another investigational study within 30 days prior to enrollment
- •Patients who improve on conventional (standard of care) therapy
- •Patients previously treated with ecallantide
- •Hypersensitivity to ecallantide
- •Pregnancy or breast feeding
- •Other definable causes of angioedema (i.e., hereditary or acquired angioedema)
- •Patients receiving C-1 inhibitor as prophylaxis
- •Treatment requiring tranexamic acid, and epsilon-aminocaproic acid
- •Receiving fresh frozen plasma within 3 days prior to enrollment
研究组 & 干预措施
Ecallantide in conjunction with Conventional Therapy
干预措施: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin (Drug)
Conventional therapy and placebo
干预措施: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin (Drug)
结局指标
主要结局
Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I.
时间窗: 18 months
次要结局
- Time to meet objective discharge criteria, Physician assessment of angioedema improvement measured using the Symptom Complex Response Assessment at 2 hours post-treatment and 4 hours post-treatment.(18 months)