NL-OMON35902撤回4 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. (RESIST-EXPERIENCED) - RESIST-EXPERIENCED
niversitair Medisch Centrum Utrecht0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- severe hemophilia A (FVIII<1%)
- •- male patients, 18 years or older;
- •- high responders (peak inhibitor levels > 5 BU);
- •- any inhibitor level at study enrollment
- •- with ability and willingness to participate to the study;
- •- previous ITI course of at least 9 months with a VWF-free FVIII concentrate (recombinant FVIII and/or monoclonally purified FVIII) at any dosage (patients who initially succeeded to clear the inhibitor and then relapsed can be included)
排除标准
- •- Concomitant systemic treatment with drugs with immunosuppressive side effects
- •- Concomitant experimental treatment
- •- Previous history of myocardial infarction and/or cerebral stroke
- •- High risk of cardiovascular, cerebrovascular or other thromboembolic events as deemed by the treating clinician
研究者
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