NL-OMON44091已完成3 期
Prospective, open-label, multicentre phase 3b study to assess the efficacy and safety of personalized prophylaxis with Human-cl rhFVIII in previously treated adult patients with severe haemophilia A - phase 3b study with Human-cl rhFVIII in patients with severe haemophilia A
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 3
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
- 年龄范围
- 18 至 99（—）
入选标准
- •(a) Severe haemophilia A (FVIII:C < 1%) according to medical history
- •(b) Male patients >= 18 years of age
- •(c) Previous treatment with a FVIII concentrate (regular prophylaxis with good compliance or on-demand treatment) for at least 150 EDs
- •(d) Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start
- •(e) Immunocompetence (CD4+ count > 200/µL)
- •(f) Freely given written informed consent
排除标准
- •Any coagulation disorder other than haemophilia A
- •(b) Present or past FVIII inhibitor activity (>= 0.6 BU) according to medical history
- •(c) Severe liver or kidney disease (ALT and AST levels > 5 times of upper limit of normal, creatinine > 120 µmol/L)
- •(d) Treatment with any investigational medicinal product (IMP) except FVIII IMP within 14 days prior to the screening visit
研究者
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