ISRCTN87293301已完成不适用
Clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII in previously treated patients with severe haemophilia A
Octapharma AG (Switzerland)0 个研究点目标入组 20 人开始时间: 2009年2月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
入排标准
- 性别
- Male
入选标准
- •1. Must have severe haemophilia A (FVIII:C less than 1%; historical value as documented in subject records)
- •2. Aged greater than 18 and less than 65 years, male
- •3. Body weight 45 kg to 110 kg
- •4. Previously treated with FVIII concentrate, at least 150 exposure days (EDs)
- •5. Immunocompetent (CD4+ count greater than 200/µL)
- •6. Negative for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) or respective viral load less than 200 particles/µL
- •7. Freely given written informed consent
排除标准
- •1. Other coagulation disorder than haemophilia A
- •2. Present or past FVIII inhibitor activity (greater than 0.6 BU)
- •3. Severe liver or kidney disease (alanine aminotransferase [ALAT] and aspartate aminotransferase [ASAT] levels greater than 5 times of upper limit of normal, creatinine greater than 120 µmol/L)
- •4. Receiving or scheduled to receive immuno-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to greater than 10 mg/day), or similar drugs
- •5. Participation in another clinical study currently or during the past month
研究者
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