EUCTR2008-001563-11-DE进行中（未招募）不适用
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of human-cl rhFVIII, a Newly Developed Human Cell-Line Derived Recombinant FVIII Concentrate in Previously Treated Patients With Severe Hemophilia A.
适应症
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
- 25
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
- •Must have severe hemophilia A (FVIII:C <1%).
- •Male subjects greater/equal 12 and less or equal than 65 years of age.
- •Body weight 25 kg to 110 kg.
- •Previously treated with FVIII concentrate, at least 150 EDs.
- •Immunocompetent (CD4+ count >200/µL)
- •Negative for anti-HIV; if positive, viral load <200 particles/µL or <400,000 copies/mL.
- •Freely given written informed consent.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other coagulation disorder than hemophilia A.
- •Present or past FVIII inhibitor activity (>0.6 BU).
- •Severe liver or kidney disease (ALT and AST levels >5 times of upper limit of normal, creatinine >120 µmol/L).
- •Receiving or scheduled to receive immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs.
- •Participation in another interventional clinical study currently or during the past month.
研究者
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已完成
不适用
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