EUCTR2009-013227-28-FR进行中（未招募）1 期
A Double-Blind, Randomized, Crossover Study of the Recovery of FACTANE 100 versus 200 IU/ml followed by an Open-Label Safety Study of FACTANE 200 IU/ml in Previously Treated Patients With Severe (FVIII:C<1%) Haemophilia A
FB BIOTECHNOLOGIES0 个研究点目标入组 13 人开始时间: 2009年8月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
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
- Male
入选标准
- •1.Severe haemophilia A patients (basal levels FVIII:C <1 IU/dl).
- •2.Male patient older than 18 years.
- •3.Patient usually treated with FACTANE 100 IU/ml.
- •4.Patient anticipated to be treated with 9 injections of FACTANE 200 IU/ml within the 3 months following the recovery study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Present or past factor VIII inhibitor titre (defined as =0.6 Bethesda Units) (last test = 3 months).
- •2.Known intolerance to any of the ingredients of FACTANE
- •3.Participation in another clinical study involving an investigational drug within the past 30 days or on going participation in another clinical study.
- •4.Any other condition that the Investigator believes could interfere with the study results or would not be in the best interest of the patient.
研究者
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