EUCTR2016-003821-40-BG进行中（未招募）1 期
Evaluation of safety following Immune Tolerance Induction treatment with turoctocog alfa in patients with haemophilia A following inhibitor development in NN7170-4213 trial
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
- 9
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
- •- Previous participation in the NN7170-4213 trial (male, age = 18 years (part A) and age = 12 years (part B)).
- •- Development of a confirmed high titre neutralising antibody towards factor VIII (>5 Bethesda Unit) after exposure to subcutaneous turoctocog alfa pegol in the NN7170- 4213 trial or development of a confirmed clinically relevant low titre inhibitor (=0.6 to =5 Bethesda Unit), defined as factor VIII activity measures (recovery) and/or bleed pattern indicating a lack of clinical response to factor VIII treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 4
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 5
- •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 hypersensitivity to trial product(s) or related products, defined as allergic reactions.
- •- Participation in another clinical trial within 1 month before screening (except participation in NN7170-4213).
- •- Any disorder, except for conditions associated with Haemophilia A which in the investigator’s opinion might jeopardise patients’ safety or compliance with the protocol.
- •- Currently receiving immune tolerance induction treatment with a factor VIII containing
- •product other than turoctocog alfa.
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