EUCTR2009-015086-31-ES进行中（未招募）不适用
Ten03: A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity Factor X in the treatment of the Factor X Deficient Subjects Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
- •Subjects who are at least 12 years of age at date of written informed consent/assent.
- •Subjects who have given written informed consent or, for subjects aged 12-17 years (inclusive), have given written assent and whose parent/guardian has
- •given written informed consent.
- •Subjects with hereditary mild to severe factor X deficiency (<20% basal FX activity), including previously untreated subjects OR those currently treated with Fresh Frozen Plasma (FFP), Prothrombin Complex Concentrate (PCC) or factor IX/X concentrate by prophylaxis or on demand.
- •Subjects who are to undergo surgery in which the investigator believes a factor X concentrate will be required due to a prior history of unusual bleeding, either spontaneously, or after surgery or trauma, in the absence of treatment with a factor X-containing product.
- •Female subjects of child-bearing potential with the exception of those entering the study for obstetric delivery must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female subject is or becomes sexually active, she must practice contraception by using a method of proven reliability for example oral contraceptives in combination with a barrier method, or IUDs (not copper IUDs) for the duration of the study, or for 8 days after the last dose of FACTOR X, whichever is longer.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Subjects who are required or expected to take other factor X-containing medications during or after surgery.
- •Subjects with a history of inhibitor development to FX or a detectable inhibitor to FX (=0.6 BU) on the Nijmegen-Bethesda assay at screening. Obtaining a
- •FX inhibitor result at screening is not mandatory if the subject is to undergo emergency surgery and the local laboratory is unable to perform the analyses prior to the surgical procedure.
- •Subjects with thrombocytopenia (platelets < 50 x 109/L).
- •Subjects who have clinically significant renal disease (creatinine >200µmol/L).
- •Subjects who have clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
- •Subjects known to have other coagulopathy or thrombophilia.
- •Subjects who are currently participating or have participated in another trial within the last 30 days, with the exception of the BPL Factor X PK study
- •(protocol number Ten01).
- •Female subjects who are breastfeeding. Subjects participating in the study for obstetric delivery must be informed that they may not breastfeed during the study.
- •Subjects who have known or suspected hypersensitivity to the investigational medicinal product or its excipients.
- •Subjects known to have abused chemicals or drugs within the past 12 months.
- •Subjects with a history of unreliability or noncooperation.
研究者
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