NCT03588741终止3 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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate safety of immune tolerance induction (ITI) treatment with turoctocog alfa (a recombinant factor VIII) in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213 (NCT02994407)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Previous participation in the NN7170-4213 trial (male, age at least 18 years (part A) and age at least 12 years (part B))
- •Development of a confirmed high titre neutralising antibody towards factor VIII (greater than 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 (at least 0.6 to below or equal to 5 Bethesda Unit), defined as factor VIII activity measures (recovery) and/or bleedpattern indicating a lack of clinical response to factor VIII treatment
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
研究组 & 干预措施
Turoctocog alfa
Experimental
干预措施: Turoctocog alfa (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: Month 0 - up to month 12
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment.
次要结局
- Response to FVIII ITI Treatment (Success, Partial Success, Failure, Other)(Month 12)
研究者
研究点 (1)
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