EUCTR2011-003825-81-HU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 32 人开始时间: 2011年11月14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
- 32
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 subject’s first HAE attack treated with icatibant as part of this study.
- •2. Documented diagnosis of HAE Type I or II. Diagnosis must be C1-1NH deficiency (C1-1NH protein level below the lower limit of normal and/or functional level <50% of normal). Diagnosis may be on the basis of historic data or by diagnostic testing conducted at the time of screening. Inclusion will be permitted initially based on medical history only if a clear diagnosis has been made based on all of the following criteria
- •-Family history
- •-Characteristic attack manifestations/recurrent attacks
- •-Historical N1-1NH deficiency as demonstrated by immunologic or functional test results
- •-Exclusion of other forms of angioedema
- •-Subsequent confirmation of the diagnosis to be made on the basis of C1-1NH level of function (all subjects)
- •3. Informed consent (and subject assent as appropriate) signed by the subject’s 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 trial that involves use of any investigational product (drug of device) within 30 days prior to study enrollment or at any time during the study.
- •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.
- •9. A physical condition that interferes with pubertal status determination
研究者
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