NCT01992549已完成3 期
Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 48
- 试验地点
- 15
- 主要终点
- Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
研究概览
简要总结
The purpose of the study is to collect long-term data on 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
- •Patients who completed GENA-05 in accordance with the study protocol
排除标准
- •Severe liver or kidney disease
- •Concomitant treatment with any systemic immunosuppressive drug;
- •Other FVIII concentrate than Human-cl rhFVIII was received between completion visit of GENA-05 and start of GENA-15 (except emergency cases).
研究组 & 干预措施
Human-cl rhFVIII
Experimental
干预措施: Human-cl rhFVIII (Biological)
结局指标
主要结局
Immunogenicity of Human-cl rhFVIII: Incidence of Inhibitors
时间窗: Maximum two years
The number of patients developing FVIII inhibitors was observed during the observation period by assessing inhibitor development by the modified Bethesda assay (Nijmegen modification) using congenital FVIII-deficient human plasma spiked with Human-cl rhFVIII. The definition threshold for a "positive" inhibitor was if the modified Bethesda assay resulted in a titre ≥0.6 BU/mL at any time point during the observation period.
次要结局
- The Occurrence of Any Adverse Event (AE)(Maximum 2 years)
- Efficacy of Human-cl rhFVIII for Surgical Prophylaxis(Maximum 2 years)
- Frequency of Spontaneous Break-through Bleeds(Maximum 2 years)
- Efficacy of Human-cl rhFVIII for the Treatment of Bleeds(Maximum 2 years)
研究者
研究点 (15)
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