Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Shire
- 入组人数
- 79
- 试验地点
- 39
- 主要终点
- Safety and Efficacy of Ecallantide
研究概览
简要总结
A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females 18 years of age or older
- •Must currently be on ACE inhibitor therapy and have received a dose within 36 hours
- •Presenting with ACEIA of the head/neck region within 12 hours after onset
- •All females must have a negative urine pregnancy test prior to administration of the study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two years post-menopausal do not require a pregnancy test.
排除标准
- •Hypersensitivity to ecallantide
- •Pregnancy or breast feeding
- •Patients who have had angioedema and were not concurrently on an ACE inhibitor
- •Patients exhibiting urticaria
- •Patients who are intubated or who have a tracheostomy related to the current episode of angioedema
- •Opinion of the investigator that the patient would not be a good candidate
- •Participation in another investigational study within 30 days prior to enrollment
研究组 & 干预措施
ecallantide 10mg
Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo.
干预措施: ecallantide 10 mg (Drug)
ecallantide 10mg
Administered as one 3 mL SC injection containing 10 mg ecallantide and one 3 mL SC injection of matching placebo.
干预措施: placebo match for 10 mg ecallantide arm (Drug)
placebo
Administered as two SC 3 mL injections
干预措施: placebo (Drug)
ecallantide 60mg
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
干预措施: ecallantide 60 mg (Drug)
ecallantide 30mg
Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.
干预措施: ecallantide 30 mg (Drug)
ecallantide 30mg
Administered as one 3 mL SC injection containing 30 mg ecallantide and one 3 mL SC injection of matching placebo.
干预措施: placebo match for 30 mg ecallantide arm (Drug)
结局指标
主要结局
Safety and Efficacy of Ecallantide
时间窗: 6 hours
Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy. Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER. A responder was defined as a patient meeting all six discharge eligibility criteria as below: • Improvement of edema to "a little better" or "a lot better" as assessed by health care provider using a five point scale • Stable vital signs (within an acceptable range) • Absence of stridor • Absence of dyspnea or use of accessory muscles during respiration • Absence of drooling • Able to drink without difficulty
次要结局
- Time to Symptom Resolution Based on the Visual Analog Scale (VAS)(6 hours)