EUCTR2005-001426-84-CZ进行中（未招募）不适用
CLINICAL STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF WILATE IN CHILDREN < 6 YEARS OF AGE WITH INHERITED VON WILLEBRAND DISEASE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- All
入选标准
- •Defined inherited VWD of any type.
- •Age <6 years at study admission.
- •DDAVP treatment known or suspected to be inadequate, insufficient or contraindicated.
- •An expected minimum of 5 exposure days to WILATE within 1 year of observation.
- •HIV-1/2 negative.
- •Freely given fully informed consent has been obtained from the patient's parents (in accordance with local laws, the informed consent of both parents might be necessary).
- •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
- •Any haematological disorder other than VWD.
- •Diagnosis of acquired VWD.
- •Any known present or past inhibitor activity against VWF or FVIII.
- •Administration of DDAVP or other blood/plasma products 5 days prior to the 1st WILATE injection
- •Administration of acetylsalicylic acid 14 days before treatment with Wilate.
- •Known history of intolerance towards plasma derived or blood products.
- •Participation in another clinical study currently or during the past four weeks.
研究者
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