NCT03196297已完成2 期
A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset
研究概览
简要总结
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia A (FVIII activity below 1%), based on medical records or results at screening
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia A - Presence of inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units) at screening measured by the Nijmegen method
研究组 & 干预措施
Concizumab
Experimental
Daily administration of concizumab to both on-demand and prophylaxis patients
干预措施: Concizumab (Drug)
Concizumab
Experimental
Daily administration of concizumab to both on-demand and prophylaxis patients
干预措施: Turoctocog alfa (Drug)
结局指标
主要结局
The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset
时间窗: During at least 24 weeks from treatment onset
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
次要结局
- Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset(During at least 24 weeks from treatment onset (week 0))
- Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset(During at least 24 weeks from treatment onset (week 0))
- The Number of Spontaneous Bleeding Episodes During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset)
- The Number of Bleeding Episodes During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset)
- Change in Fibrinogen During 24 Weeks From Treatment Onset(During 24 weeks from treatment onset (week 0))
- Change in Fibrinogen During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Change in D-dimer During 24 Weeks From Treatment Onset(During 24 weeks from treatment onset (week 0))
- Change in Prothrombin Fragment 1 + 2 (F1 + F2) During 24 Weeks From Treatment Onset(During 24 weeks from treatment onset (week 0))
- Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Change in D-dimer During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Change in Activated Partial Thromboplastin Time (APTT) During 24 Weeks From Treatment Onset(During 24 weeks from treatment onset (week 0))
- The Number of Spontaneous Bleeding Episodes During at Least 24 Weeks From Treatment Onset(During at least 24 weeks from treatment onset)
- Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration at 24 Weeks(Prior to the last dose administration at 24 weeks)
- Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration After at Least 76 Weeks(Prior to the last dose administration after at least 76 weeks)
- Endogenous Thrombin Potential Prior to the Last Dose Administration at 24 Weeks(Prior to the last dose administration at 24 weeks)
- Change in Anti-thrombin (AT) During 24 Weeks From Treatment Onset(During 24 weeks from treatment onset (week 0))
- Thrombin Generation Velocity Index Prior to the Last Dose Administration at 24 Weeks(Prior to the last dose administration at 24 weeks)
- Thrombin Generation Velocity Index Prior to the Last Dose Administration After at Least 76 Weeks(Prior to the last dose administration after at least 76 weeks)
- Change in Prothrombin Fragment 1 + 2 (F1 + F2) During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Change in Anti-thrombin (AT) After at Least 76 Weeks From Treatment(During at least 76 weeks from treatment onset (week 0))
- Concentration of Concizumab Prior to the Last Dose Administration at 24 Weeks(Prior to the last dose administration at 24 weeks)
- Concentration of Concizumab Prior to the Last Dose Administration After at Least 76 Weeks(Prior to the last dose administration after at least 76 weeks)
- Peak Thrombin Generation Prior to the Last Dose Administration at 24 Weeks(Prior to the last dose administration at 24 weeks)
- Peak Thrombin Generation Prior to the Last Dose Administration After at Least 76 Weeks(Prior to the last dose administration after at least 76 weeks)
- Change in Prothrombin Time (PT) During 24 Weeks From Treatment Onset(During 24 weeks from treatment onset (week 0))
- Change in Prothrombin Time (PT) During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Change in Activated Partial Thromboplastin Time (APTT) During at Least 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Endogenous Thrombin Potential Prior to the Last Dose Administration After at Least 76 Weeks(Prior to the last dose administration after at least 76 weeks)
研究者
研究点 (1)
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