NCT01712438已完成3 期
Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 110
- 试验地点
- 49
- 主要终点
- Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
研究概览
简要总结
Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients
- •Severe Hemophilia A (FVIII:C <1%)
- •No previous treatment with FVIII concentrates or other blood products containing FVIII
排除标准
- •Diagnosis with a coagulation disorder other than Hemophilia A
- •Severe liver or kidney disease
- •Concomitant treatment with any systemic immunosuppressive drug
结局指标
主要结局
Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
时间窗: maximum 5 years (100 exposure days)
The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development using the modified Bethesda assay (Nijmegen modification). The definitions for thresholds were ≥0.6 to \<5 BU/mL for a "low titre" inhibitor and ≥5 BU/mL for a "high-titre" inhibitor.
次要结局
- Efficacy of Human-cl rhFVIII for Surgical Prophylaxis(Maximum 5 years (100 exposure days))
- Efficacy of Human-cl rhFVIII for the Treatment of Bleeds(Maximum 5 years (100 exposure days))
- Frequency of Spontaneous Break-through Bleeds(Maximum 5 years (100 exposure days))
研究者
研究点 (49)
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