Clinical Study to Investigate the Efficacy, Safety, and Immunogenicity of Human-cl rhFVIII in Previously Treated Patients With Severe Hemophilia A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Octapharma
- 入组人数
- 32
- 试验地点
- 17
- 主要终点
- Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months
研究概览
简要总结
This study will determine the efficacy of human-cl rhFVIII in previously treated patients with severe hemophilia A during prophylactic treatment, treatment of bleeding episodes and in surgical prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe hemophilia A ((FVIII:C <= 1%)
- •Male subjects >= 12 years of age
- •Previously treated with FVIII concentrate, at least 50 EDs
- •Immunocompetent (CD4+ count > 200/ul)
- •Negative for anti- HIV; if positive, viral load < 200 particles/u; or <400,000 copies/mL
排除标准
- •Other coagulation disorder than hemophilia A
- •Present of past FVIII inhibitor activity (.= 0.6 BU)
- •Severe liver and kidney disease
- •Receiving of scheduled to receive immuno-modulating drugs
研究组 & 干预措施
human cl-rhFVIII
干预措施: recombinant Factor VIII (Biological)
结局指标
主要结局
Efficacy Assessment After a Total of at Least 50 EDs Per Subject at the End of the Study at 6 Months
时间窗: At least 50 Exposure Days and at least 6 months
Frequency of spontaneous breakthrough bleeds/months under prophylactic treatment.
Efficacy of Treating Bleeding Episodes
时间窗: After each bleeding episode, up to 6 month
At the end of a bleeding episode, efficacy was assessed as: * Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion * Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8-12 hours after an infusion requiring up to 2 infusions for complete resolution * Moderate: Probable or slight beneficial effect within approximately 12 hours after the first infusion requiring more than two infusions for complete resolution * None: No improvement within 12 hours, or worsening of symptoms, requiring more than 2 infusions for complete resolution Efficacy was rated
次要结局
未报告次要终点