EUCTR2005-003819-71-BE进行中（未招募）1 期
EDEMA3: Evaluation of DX-88’s Effects in Mitigating Angioedema 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
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Dyax Corp
- 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 = 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
- •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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