EUCTR2012-004606-10-GB进行中（未招募）1 期
Multicentre, Non-controlled, Prospective, Post-Marketing Safety Study Following Long-Term Prophylactic Optivate® Treatment in Subjects with Severe Haemophilia A. - Post Marketing study following long term prophylactic Optivate usage
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7
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
入选标准
- •- Written informed consent or, in the case of children and adolescents (less than 18 years of age) have given written assent (where possible) and whose parent/guardian has given written informed consent.
- •- Severe haemophilia A (< 1% FVIII:C). Subjects suffering from severe haemophilia A
- •(< 2%) may be enrolled, but only after approval by BPL. Subjects with a FVII
- •< 2% may not constitute more than 50% of the total patient population. A separate
- •statistical evaluation will be conducted for the < 1% and < 2% populations. Basal
- •FVIII level taken from subject’s lowest level recorded, or the level measured at screening, whichever is lower.
- •- Previously Treated Patients (PTPs) with > 150 exposure days on prior FVIII therapy (of
- •which at least the last 50 EDs or 2 years treatment can be confirmed by way of subject
- •- Immunocompetent subjects with CD4 (cluster differentiation 4) count > 200 /µL.
- •- Human Immunodeficiency Virus (HIV) negative subjects or a viral load < 200 particles
- •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 9
- •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 FVIII or a positive result on the Nijmegen-Bethesda at screening (quantitative result of > 0.6 Bethesda Units [BU]) prior to the administration of Optivate®.
- •- Known or suspected hypersensitivity to the Investigational Medicinal Product (IMP) or its excipients.
- •- Clinically significant i.e. symptomatic liver disease and/or (historical, within the last 12 months, serum Alanine Aminotransferase [ALT] levels greater than three times the
- •upper limit of the normal range), symptomatic renal disease and/or (historical, within the last 12 months, serum creatinine > 200?mol/L), or coagulopathy other than haemophilia A.
- •- History of unreliability or non-cooperation (including not being able to complete the study diary).
- •- Participating in, or have taken part in another trial within the last 30 days.
研究者
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