EUCTR2012-003093-98-GB进行中（未招募）1 期
A Phase III Open, Multicentre Study to Confirm the Safety, Pharmacokinetics and Efficacy of BPL’s High Purity Factor X in the Prophylaxis of Bleeding in Factor X Deficient Children Under the Age of 12 Years
适应症
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
- All
入选标准
- •Children with hereditary severe or moderate FX deficiency (<5 IU/dL FX:C, based on their lowest reliable FX:C recorded)
- •Children under 12 years old, whose parent/guardian has given informed consent.
- •Children with a history of severe bleeding (a minimum of one bleed with a bleed score of 3 or 4, Appendix XI), or a mutation in the F10 gene causing a documented severe bleeding phenotype.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Children must not suffer from clinically significant liver disease, renal disease, or other coagulopathy or thrombophilia, and must have no history of inhibitors to FX.
- •Children who have known or suspected hypersensitivity to the investigational medicinal product or its excipients.
- •Children with a history of unreliability or non-cooperation.
- •Children who are participating or have taken part in another trial within the last 30 days.
- •Children planning more than 4 weeks’ continuous absence from the locality of the investigational site, between the Screening Visit and the End of Study Visit.
研究者
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