EUCTR2012-001711-23-GB进行中（未招募）1 期
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients with Severe Haemophilia A
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 68
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
- Male
入选标准
- •- Male patients with severe congenital haemophilia A (FVIII activity level < 1%)
- •- Age below 12 years at screening (for Turkey only: Age above 3 and below 12 years at screening)
- •- Weight =10 kg
- •- Documented history of > 150 ED to FVIII products for patients aged 6-11 years and > 50 ED to FVIII products for patients aged 0-5 years (for Turkey only: Documented history of > 150 ED to FVIII products for patients aged 6-11 years and > 50 ED to FVIII products for patients aged 3-5 years)
- •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
- •Any history of FVIII inhibitors
研究者
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