NCT02938585已完成3 期
Efficacy and Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months
研究概览
简要总结
This trial is conducted in China. The aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in Chinese patients with severe haemophilia A (FVIII≤1%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age from 0 years
- •With the diagnosis of severe congenital haemophilia A (FVIII≤1%)
- •History of exposure days (ED) to any FVIII products fulfilling the criteria of previously treated patients:
- •Patients of 12 years or above: 100 exposures days (ED) or more
- •Patients below 12 years: 50 exposure days (ED) or more
排除标准
- •Inhibitors to factor VIII (≥0.6 BU) at screening as assessed by central laboratory
- •Known history of FVIII inhibitors
研究组 & 干预措施
Prophylactic treatment
Experimental
干预措施: turoctocog alfa (Drug)
On-demand treatment
Experimental
干预措施: turoctocog alfa (Drug)
结局指标
主要结局
Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 6 Months
时间窗: Month 0-6
The haemostatic effect of turoctocog alfa when used for treatment of bleeding episodes in both prophylaxis and on-demand regimen was evaluated during month 0-6. The effect was assessed on a four-point scale for haemostatic response, excellent, good, moderate and none.
次要结局
- Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 6 Months(Month 0-6)
- Number of Bleeds (Total Bleeds Assessed as Annual Bleeding Rate) Per Participant: 24 Months(Month 0-24)
- Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (6 Months)(Month 0-6)
- Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 24 Months(Month 0-24)
- Consumption of Turoctocog Alfa for Bleeding Treatment: Average Dose to Treat a Bleed (24 Months)(Month 0-24)
- Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (6 Months)(Month 0-6)
- Consumption of Turoctocog Alfa for Bleeding Treatment: Number of Injections Per Bleed (24 Months)(Month 0-24)
- Frequency of Adverse Events (6 Months)(Month 0-6)
- Frequency of Adverse Events (24 Months)(Month 0-24)
- Frequency of Serious Adverse Events (6 Months)(Month 0-6)
- Frequency of Serious Adverse Events (24 Months)(Month 0-24)
- Haemostatic Effect of Turoctocog Alfa (Surgery): 6 Months(Month 0-6)
- Haemostatic Effect of Turoctocog Alfa (Surgery): 24 Months(Month 0-24)
- Loss of Blood (Surgery): 6 Months(Month 0-6)
- Loss of Blood (Surgery): 24 Months(Month 0-24)
- Requirements for Transfusion (Surgery): 6 Months(Month 0-6)
- Requirements for Transfusion (Surgery): 24 Months(Month 0-24)
- Adverse Events (Surgery): 6 Months(Month 0-6)
- Adverse Events (Surgery): 24 Months(Month 0-24)
- Serious Adverse Events (Surgery): 6 Months(Month 0-6)
- Serious Adverse Events (Surgery): 24 Months(Month 0-24)
- Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 6(Month 0, Month 6)
- Change in Total Scores for Reported Health-related Quality of Life (for Participants): Month 24(Month 0, Month 24)
- Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 6(Month 0, Month 6)
- Change in Total Scores for Reported Health-related Quality of Life (for Parents): Month 24(Month 0, Month 24)
- Incremental Recovery of FVIII(Days 1-2)
- Area Under the Curve (AUC0-inf)(Days 1-2)
- Half-life (t½)(Days 1-2)
- Clearance (CL)(Days 1-2)
- Highest Measured FVIII Activity in the Profile (Cmax)(Days 1-2)
- Incidence Rate of Inhibitory Antibodies Against FVIII (≥0.6 BU): 6 Months(Month 0-6)
- Haemostatic Effect of Turoctocog Alfa (Treatment of Bleeds): 24 Months(Month 0-24)
- Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (6 Months)(Month 0-6)
- Consumption of Turoctocog Alfa for Bleeding Treatment: IU/kg Per Bleed (24 Months)(Month 0-24)
- Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (6 Months)(Month 0-6)
- Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: Average Preventive Dose (24 Months)(Month 0-24)
- Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (6 Months)(Month 0-6)
- Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Month (24 Months)(Month 0-24)
- Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (6 Months)(Month 0-6)
- Consumption of Turoctocog Alfa During Preventive Treatment Per Participant: IU/kg Per Year (24 Months)(Month 0-24)
- Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (6 Months)(Month 0-6)
- Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Month (24 Months)(Month 0-24)
- Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (6 Months)(Month 0-6)
- Total Consumption of Turoctocog Alfa Per Participant: IU/kg Per Year (24 Months)(Month 0-24)
研究者
研究点 (1)
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