EUCTR2017-003902-42-IT进行中（未招募）1 期
F9 Genotype and PK Hemophilia B International Study - GePKHIS
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
- 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
- 性别
- Male
入选标准
- •- Severe or moderately severe haemophilia B patients (FIX < 3 IU/dL);
- •- Age =18 years;
- •- No bleedings in the last week
- •- On prophylaxis with Nonacog alfa for >150 exposure days (1 exposure day = 1 day of treatment with one or more infusions of Nonacog alfa) following a once-a-week infusion schedule (usually on Monday);
- •- 5-7 days wash out from the previous Nonacog alfa administration;
- •- Signed Informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Any kind of bleeding, in the last week before the PK;
- •- Sever hepatic disease, PT<70%;
- •- Ongoing HIV treatment (HAART);
- •- Previous or current FIX inhibitor;
- •- Previous treatment with rFIX EHL concentrates.
研究者
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