EUCTR2011-003825-81-ES进行中（未招募）1 期
A Multicenter, Open-Label, Non-Randomized Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Single Subcutaneous Administration of Icatibant in Children and Adolescents with Hereditary Angioedema
Shire Orphan Therapies, Inc0 个研究点目标入组 36 人开始时间: 2011年11月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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. Two through 17 years of age, inclusive (ie, from the second birthday until the day prior to the eighteenth birthday) at the time of the subjects first attack.
- •2. Documented diagnosis of HAE Type I or II. Diagnosis must be confirmed by documented immunogenic and/or functional C1-INH deficiency results (<50% of normal levels). Diagnosis may be on the basis of historic data or by diagnostic testing conducted at the time of screening.
- •3. Informed consent (and subject assent as appropriate) signed by the subjects parent(s) or legal guardian(s).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of angioedema other than HAE.
- •2. Participation in another clinical study during the 30 days prior to treatment.
- •3. Any known factor/disease that might interfere with the treatment compliance, study conduct or result interpretation.
- •4. Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.
- •5. Treatment with ACE inhibitors within 7 days prior to treatment.
- •6. Use of hormonal contraception within the 90 days prior to treatment.
- •7. Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within the 90 days prior to treatment.
- •8. The subject is pregnant or breastfeeding.
研究者
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