NCT00930176已完成3 期
A Phase III Open, Multicentre Study to Investigate the Pharmacokinetics, Safety and Efficacy of BPL's High Purity Factor X in the Treatment of Severe and Moderate Factor X Deficiency.
Bio Products Laboratory16 个研究点 分布在 5 个国家目标入组 16 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 16
- 主要终点
- FX:C Incremental Recovery
研究概览
简要总结
The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg.
The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent given, or for subjects aged 12-17 years, have given written assent and whose parent/guardian has given written informed consent
- •At least 12 years of age at dtae of written informed consent
- •Have hereditary severe or moderate FX deficiency
- •Currently treated with Fresh Frozen Plasma FFP, Prothrombin Complex Concentrate PCC or factor IX/X concentrate
- •Must have a minimum of one spontaneous or menorrhagic bleed in the last 12 months which required treatment of FFP, PCC or factor IX/X concentrate. Newly diagnosed subjects who present at the hospital with a bleed may be included
- •Must have had at least 7 days, and ideally 10-14 days, since an infusion of either FFP, PCC or factor IX/X concentrate at Baseline Visit
- •Females of child bearing potential must have a negative result on a HCG based pregnancy test. If they are or become sexually active, they must practise contraception by using a method of proven reliability for the duration of the study
排除标准
- •Have a history of inhibitor development to FX or a positive result at the Screening Visit
- •Bleeding at the appointment for the PK assessment
- •Subjects who have thrombocytopenia
- •Have clinically significant liver disease
- •Known to have other coagulopathy or thrombophilia
- •Have known or suspected hypersensitivity to the investigational medicinal product or its excipients
- •Have abused chemicals or drugs within the past 12 months
- •Have a history of unreliability or non-cooperation
- •Participating or have taken part in another trial within the last 30 days, with the exception of BPL FX surgery study - Protocol Ten
- •In such cases, subjects should have completed their End of Study Visit either before or on the day of Screening Visit for this study
- •Female subjects who are pregnant or lactating
- •Subjects planning greater than 4 weeks absence from the locality of the Investigational site, between the screening visit and the repeat PK assessment
结局指标
主要结局
FX:C Incremental Recovery
时间窗: At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)
Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg). Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
FX:C Half-life
时间窗: At Baseline and at 6 months post-Baseline
Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
次要结局
未报告次要终点
研究者
研究点 (16)
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