EUCTR2011-003825-81-DE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8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 to <18 years of age (ie, from the second birthday through the day prior to the eighteenth birthday) at the time of enrollment and treatment with icatibant.
- •- Prepubertal and pubertal/postpubertal subjects experiencing an acute cutaneous, abdominal, or laryngeal HAE attack treated with icatibant as part of this study.
- •- Pubertal/postpubertal subjects with HAE who are treated with icatibant as part of this study, but not during an attack.
- •2. Documented diagnosis of HAE type I or II. Diagnosis may be on the basis of historical data: family history, characteristic attack manifestations, recurrent attacks, historical C1-INH deficiency, and exclusion of other forms of angioedema. Inclusion will be permitted initially based on medical history only if a clear diagnosis has been made based on all of the preceding criteria. However, the diagnosis must be confirmed prior to treatment by documented immunogenic and/or functional C1-INH deficiency (C1-INH protein level below the lower limit of normal and/or functional level <50% of normal) as performed by the Sponsor’s central laboratory.
- •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: 30
- •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 or 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 angiotensin converting enzyme (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. Pregnancy or breastfeeding.
- •9. A physical condition that interferes with pubertal status determination.
研究者
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