EUCTR2011-000987-92-SK进行中（未招募）1 期
Open-label, phase II, single arm study to evaluate the safety, immunogenicity, pharmacokinetics and efficacy of recombinant human C1 inhibitor for the treatment of acute attacks in pediatric patients with hereditary angioedema, from 2 up to and including 13 years of age - Safety of Ruconest in 2-13 year old HAE patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •From 2 up to and including 13 years of age
- •Clinical and laboratory confirmed diagnosis of HAE (baseline C1INH activity <50% of normal)
- •Signed written informed consent (parental permission) signed by the legal guardian(s)
- •Clinical symptoms of an acute HAE attack
- •Onset of eligible symptoms within 5 hours from the moment at which medical evaluation to determine eligibility has occurred
- •IS score for at least one anatomical location at the time of initial evaluation of at least 3 (moderate severity or greater) without signs of spontaneous regression
- •24h or more have passed since the patient’s last study treatment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •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
- •A diagnosis of acquired C1INH deficiency (AAE)
- •A medical history of allergy to rabbits or rabbit-derived products (including rhC1INH, antisera), or positive anti-rabbit epithelium (dander) IgE test (cut off>0.35 kU/L in ImmunoCap® assay (Phadia, Sweden) or equivalent)
- •Treatment with investigational drug in another clinical study in the last 30 days
- •Any clinical significant abnormality in the physical examination and/or the routine laboratory assessments, that in the opinion of the Investigator makes the patient unsuitable for participation in the study
- •Any condition or treatment that in the opinion of the investigator might interfere with the evaluation of the study objectives
- •Any changes since screening that would exclude patient based on above exclusion criteria.
- •10 HAE attacks were previously treated with study medication.
- •Suspicion for an alternate explanation of the symptoms other than an acute HAE attack.
- •Use of any disallowed concomitant medication since onset of acute HAE attack
研究者
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