EUCTR2006-002857-54-DE进行中（未招募）不适用
International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- •Patients with defined inherited vWD of any type, not responding to DDAVP treatment, who need treatment with plasma derived vWF may be included. Age > 6 and < 85 years. Patients who did not receive other plasma derived or blood products 72 hours before treatment with WILOCTIN, who did not receive DDAVP 15 days or acetylsalicylic acid 7 days before treatment. Patients without severe liver or kidney disease.
- •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
- •Administration of other plasma derived or blood product 72 hours before treatment.
- •Administration of DDAVP 15 days before treatment.
- •Administration of acetylsalicylic acid 7 days before treatment.
- •Known history of intolerance versus plasma derived or blood products.
- •Symptomatic infection.
- •Severe liver or kidney disease (ALAT 5x > normal value, creatinine > 120 µmol/l).
- •Participation in another clinical study currently or during the past four weeks.
- •Pregnancy or lactating women.
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