EUCTR2008-007019-33-IT进行中（未招募）不适用
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 - RES.I.ST.EXPERIENCED
FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI0 个研究点目标入组 50 人开始时间: 2009年3月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •a. severe hemophilia A (FVIII<1%) b. male patients, any age; c. high responders (peak inhibitor levels > 5 BU); d. with any inhibitor level at study enrolment; e. with ability and willingness to participate to the study; f. with no concomitant systemic treatment with drugs with immunosuppressive side effects (eg. Corticosteroids, if used more than 5 days every iii months and/or at a dose of > 2mg/kg or 60 mg/day, azathioprine, cyclophosphamide, high?dose immunoglobulin as well as the use of a protein A column or plasmapheresis, interferons);g. with no concomitant experimental treatment. h. previous ITI course of at least 9 monthswith a VWF-free FVIII concentrate at any dosage, such as recombinant FVIII and/or monoclonally purified FVIII. i. 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
- •see inclusion criteria
研究者
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