EUCTR2011-005210-11-NL进行中（未招募）1 期
A Phase II/III, multicenter, partially randomized, open label trial investigating safety and efficacy of on-demand and prophylactic treatment with BAY 94-9027 in Severe Hemophilia A - PROTECT VIII
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 145
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
- •Male; 12 to 65 years of age (or Male 18-65 years of age in countries where enrollment of minors is not permitted)
- •Subjects with severe hemophilia A (baseline FVIII activity FVIII:C <1%) determined by measurement at the time of screening or from reliable prior documentation (eg, measurement in other clinical trials, result from approved clinical laboratory)
- •Previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 150 ED
- •Immunocompetent. If HIV positive, CD4+ lymphocyte count >200/mm3
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current evidence of inhibitor to FVIII with a titer = 0.6 BU/mL, measured by the Nijmegen modified Bethesda assay at the time of screening (central laboratory) (BU: Bethesda unit)
- •History of inhibitor to FVIII with a titer = 0.6 BU, or clinical history suggestive of inhibitor requiring modification of treatment. Subjects with a maximum historical titer of 1.0 BU on a single measurement but with at least 3 subsequent successive negative results (< 0.6 BU) thereafter are eligible
- •Any other inherited or acquired bleeding disorder in addition to Hemophilia A
- •Platelet count < 100,000/mm3
- •Creatinine > 2x upper limit of normal
- •AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)
- •The subject is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of study entry. Subjects who are currently participating in an investigational study in which they are treated with a currently marketed FVIII concentrate are not excluded. Subjects currently treated with BAY 81-8973, and who have received at least 100 ED with the investigational product, may continue treatment with the product up to the start of Visit 1.
- •Any subject who is receiving chemotherapy, immune modulatory drugs other than anti-retroviral chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids within the last 3 months. Brief courses of prednisone/methyprednisolone (< 14 days) for treatment of disorders such as synovitis, asthma, etc are allowed at the discretion of the treating physician.
研究者
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