EUCTR2008-007016-15-GB进行中（未招募）1 期
Randomised Study of First Time Immunotolerance Induction in Patients with Severe Type A Haemophilia with Inhibitor at High Risk of Failure: Comparison of Induction of Immune Tolerance with FVIII Concentrates with or without Von Willebrand Factor
niversity of Milan0 个研究点目标入组 148 人开始时间: 2010年3月15日最近更新:
适应症
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
- 148
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) At least one of the following risk factors for ITI failure
- •- peak inhibitor titre more than 200 BU/ml
- •- inhibitor titre at start of treatment more than 10 BU/ml
- •- more than 7 years of age
- •- more than 2 years between inhibitor occurrence and ITI
- •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 corticosteroids, if used more 5 days every 3 months and/or at a dose of more than 2mg/kg or 60mg/day), azathioprine, cyclophosphamide, high dose immunoglobulin)
- •2) use of a protein A column or plasmapheresis
- •3) treatment with interferons
- •4) concomitant experimental treatment
- •5) previous ITI attempt
- •6) previous history of myocardial infarction and/or cerebral stroke
- •7) high risk of cardiovascular, cerebrovascular or other thrombembolic events as deemed by the treating physician
- •8) patients with known hypersensitivity to anu of the the constituents of any of the FVIII products that can be used in the study
研究者
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