EUCTR2005-004435-22-CZ进行中（未招募）不适用
INCIDENCE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEAMOPHILIA A TREATED WITH OCTANATE - AVI-40-3
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
- •Previously untreated patients with severe (FVIII:C < 2%) haemophilia A.
- •Patients who will be registered for regular treatment at the study site.
- •Patients without any previous treatment with FVIII concentrates or other blood
- •products containing FVIII.
- •Patients without any inhibitor activity prior to admission (cut-off: 0.6 B.U.)
- •Freely given fully informed consent has been obtained from the patient or from
- •the patient's parent/legal guardian.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with any defined bleeding disorder other than haemophilia A (e.g. von
- •Willebrand disease).
- •Patients with a FVIII:C above 2%.
- •Patients requiring Interferon therapy
- •Participation in another clinical study currently or during the past four weeks.
研究者
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