NL-OMON49249已完成不适用
Immune tolerance induction (ITI) in patients with hemophilia A: <br>pathophysiologic mechanisms and difference in efficacy between various types of factor VIII (FVIII) products - HIP study: Haemophilia A Immune tolerance induction Project
niversitair Medisch Centrum Utrecht0 个研究点目标入组 45 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 64（—）
入选标准
- •- Age: 6 years and older
- •- Previously confirmed Hemophilia A
- •- Previously and frequently (> 50 ED) treated with factor VIII
- •- Willing and be able to understand the study information and sign the informed consent form;Different subgroups:
- •* 10 adults with an inhibitor (5 patients with mild or moderate hemophilia A, 5 patients with severe hemophilia A)
- •* 10 adults without an inhibitor after successful ITI
- •* 20 patients (10 adults, 10 children age > 6 years) without an inhibitor and without a history of ITI
排除标准
- •- Documented history of persisting severe anaemia (defined as haemoglobin <6.0 mmol/L for men and women)
- •- Other haematologic or immunologic comorbidity
- •- Recent (< 3 months) or actual use of immunosuppressive drugs (< 9 months for rituximab, < 3 months for other immunosuppressive drugs)
- •- Active infection at the moment of blood withdrawal
研究者
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