EUCTR2005-003819-71-IT进行中（未招募）不适用
A double-blind, placebo-controlled study followed by a repeat dosing phase to assess the efficacy and safety of DX-88 recombinant plasma kallikrein inhibitor for the treatment of acute attacks of Hereditary Angioedema - Edema 3
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GENZYME
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age 10 years or older 2. Documented diagnosis of HAE, Type I or II. Diagnosis must meet the following criteria Documented clinical history consistent with HAE, Documented reduction of either functional or antigenic C1-INH below the lower limit of normal as defined by the laboratory performing the test , Documented reduction of C4 below the lower limit of normal as defined by the laboratory performing the test , and Age of reported onset of first symptoms minus/equal 25 years OR documented C1q level at or above the lower limit of normal as defined by the laboratory performing the test 3. Executed informed consent 4. Enrollment Visit An acute attack of HAE having at least one symptom complex with a severity assessment of moderate or severe 5. Enrollment Visit Presentation for treatment at the site within 8 hours of patient recognition of moderate to severe symptoms in an acute attack of HAE
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Receipt of an investigational drug or device, other than DX-88, within 30 days prior to study enrollment 2. Treatment with non-investigational C1-INH within 7 days prior to study enrollment 6 3. Diagnosis of acquired angioedema AAE , estrogen dependent angioedema and/or drug induced angioedema including angiotensin-converting enzyme inhibitor induced angioedema 4. Pregnancy or breast feeding 5. Patients who have received DX-88 in EDEMA2 or any other studies with DX-88 within 7 days of presentation for dosing in the Double-blind Phase
研究者
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