EUCTR2009-016029-32-IT进行中（未招募）不适用
MECHANISM OF ACTION AND EFFICACY OF AN ALTERNATIVE IMMUNOTOLERANCE REGIMEN BASED ON MODULATION OF IMMUNE RESPONSES: A NEW CHANCE FOR HAEMOPHILIA PATIENTS WITH REFRACTORY INHIBITORS ? - ALTERNATIVE IMMUNOTOLERANCE REGIME
STRUTTURA SEMPLICE GESTIONE-ORG.-FUNZ. HUB EMOFILIA0 个研究点开始时间: 2009年11月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.patients with haemophilia A 2.any age 3.high responder inhibitors (peak inhibitor levels > 5 BU) 4.previous failure of ITI with any dosage of a FVIII concentrate, such as recombinant FVIII, monoclonally purified FVIII and/or FVIII/vWF concentrate 5.patients in whom the inhibitor was initially cleared, who then relapsed 6.ability to participate in the study and comply with the study-related activities 7.written informed consent
- •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.lack of informed consent 2.concomitant systemic treatment with drugs with immunosuppressive side effects for other diseases 3.hypersensitivity to cyclosporine or any of its components 4.renal failure 5.concomitant autoimmune disease or cancer 6.uncontrolled hypertension 7.HBV (HbsAg positive patients), HCV and HIV-positive patients, tuberculosis
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