EUCTR2009-011145-18-GB进行中（未招募）不适用
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 - A PK study of BPL's FX in patients with FX deficiency
Bio Products Laboratory Ltd0 个研究点目标入组 16 人开始时间: 2009年9月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
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
- •Informed consent
- •At least 12 years of age
- •With hereditary severe or moderate factor X deficiency (<5% basal activity at diagnosis)
- •Currently treated with fresh frozen plasma (FFP), prothrombin complex concentrates (PCC) or factor IX/X concentrate
- •Have had a minimum of one spontaneous or menorrhagic bleed in the last 12 months which required treatment with either FFP, PCC or factor IX/X concentrate
- •At least 7 days, and ideally 10-14 days, since an infusion of FFP, PCC or factor IX/X concentrate at the Baseline Visit
- •Female subjects of childbearing potential must not be pregnant at entry to the study and must practice contraception for the duration of the study.
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •History of inhibitor development to FX, or a positive inhibitor result at the Screening Visit
- •Bleeding at the Baseline Visit
- •Subjects with thrombocytopenia, clinically significant renal disease or clinically significant liver disease
- •Subjects with other coagulopathy or thrombophilia
- •Known or suspected hypersensitivity to the investigational medicinal product or its excipients
- •Known to have abused chemicals or drugs within the past 12 months
- •History of unreliability or non-cooperation
- •Participation in another clinical trial within the past 30 days, with the exception of BPL FX surgery study (protocol No Ten03). In such cases, subjects should have completed their End-of-Study Visit either before or on the day of the Screening Visit for this study
- •Female subjects who are pregnant or lactating.
- •Subjects who are planning more than 4 weeks absence from the locality of the investigational site, between the Screening Visit and the Repeat PK Assessment.
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