EUCTR2008-007019-33-GB进行中（未招募）1 期
Immune Tolerance Induction study in patients with severe Type A Haemophilia with Inhibitor after failure of a previous induction of immune tolerance with FVIII concentrates without Von Willebrand Factor
niversity of Milan0 个研究点目标入组 50 人开始时间: 2010年3月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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 (FVIII less than 1% of normal)
- •2) Males of any age
- •3) High responders (peak titre more than 5 BU/ml)
- •4) Any inhibitor at time of enrolment
- •5) With ability and willingness to participate in the study
- •6) Previous ITI course of at least 9 months with a VWF-free FVIII concentrate at any dosage, such as recombinant FVIII and/or monoclonally purified FVIII
- •7) Patients who initially succeeded to clear the inhibitor and then relapsed can be included
- •Are the trial subjects under 18? yes
- •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) concomitant systemic treatment with drugs with immunosuppressive side effects (eg corticosteriods, if used more than 5 days every 3 months and/or at a dose of more than 2 mg/kg or 60 mg/day), azathiorpine, cyclophosphamide, high dose immunoglobulin)
- •2) use of protein A column or plasmapheresis
- •3) treatment with interferons
- •4) concomitant experimental treatment
- •5) previous history of myocardial infarction and/or cerebral stroke
- •6) high risk of cardiovascular, cerebrovascular or other thromboembolic events as deemed by the treating clinician
- •7) patients with known hypersenitivity to any of the constituents of any of the FVIII products that can be used in the study
研究者
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