EUCTR2011-001033-16-GR进行中（未招募）1 期
Safety and Efficacy of NNC 0155-0000-0004 in Prevention and Treatment of Bleeds in Paediatric Previously Untreated Patients with Haemophilia A - guardian™4
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
入选标准
- •- Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the patient)
- •- Male patients with congenital severe haemophilia A (baseline level FVIII <=1%)
- •- Age < 6 years
- •- No prior use of purified clotting factor products (previous exposure to blood components is acceptable)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •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
- •- Known or suspected allergy to hamster protein or intolerance to trial product(s) or related products
- •- Previous participation in this trial defined as withdrawal after administration of trial product
- •- Congenital or acquired coagulation disorders other than haemophilia A
- •- FVIII inhibitor (= 0.6 BU/mL) at screening
- •- Ongoing treatment or planned treatment during the trial with immunomodulatory agents (e.g. intravenous immunoglobulin (IVIG)), routine systemic corticosteroids)
- •- Platelet count <50,000 platelets/µL
研究者
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