A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The Number of Bleeding Episodes
研究概览
简要总结
This trial is conducted in Africa, Asia, Europe and North America. 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 haemophilia A and B patients with inhibitors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 haemophilia A or B patients with inhibitors aged 18 years or older at the time of signing informed consent - Patients currently in need of treatment with bypassing agents
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance induction therapy or prophylaxis with FVIII or FIX
研究组 & 干预措施
Concizumab
Concizumab administered in both the main phase and extension phase, with eptacog alfa administered on-demand during bleeding episodes
干预措施: Concizumab (Drug)
Concizumab
Concizumab administered in both the main phase and extension phase, with eptacog alfa administered on-demand during bleeding episodes
干预措施: Eptacog alfa (Drug)
Eptacog alfa and concizumab
Eptacog alfa administered on-demand during bleeding episodes as the only intervention during the main phase. Concizumab given in the extension phase
干预措施: Concizumab (Drug)
Eptacog alfa and concizumab
Eptacog alfa administered on-demand during bleeding episodes as the only intervention during the main phase. Concizumab given in the extension phase
干预措施: Eptacog alfa (Drug)
结局指标
主要结局
The Number of Bleeding Episodes
时间窗: During at least 24 weeks from treatment onset (week 0)
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented.
次要结局
- The Number of Bleeding Episodes(During at least 76 weeks from treatment onset (week 0))
- The Number of Spontaneous Bleeding Episodes(During at least 76 weeks from treatment onset (week 0))
- 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))
- Number of Treatment-emergent Adverse Events (TEAEs) Within 24 Hours After Eptacog Alfa Administration(Within 24 hours after eptacog alfa administration)
- Change in D-dimer(During at least 76 weeks from treatment onset (week 0))
- Change in Prothrombin Time (PT)(During at least 76 weeks from treatment onset (week 0))
- Change in Anti-thrombin (AT)(After at least 76 weeks from treatment onset (week 0))
- Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value(Prior to the last dose administration after atleast 76 weeks)
- 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))
- Peak Thrombin Generation(Prior to the last dose administration after atleast 76 weeks)
- Endogenous Thrombin Potential(Prior to the last dose administration after atleast 76 weeks)
- Change in Fibrinogen(During at least 76 weeks from treatment onset (week 0))
- Change in Prothrombin Fragment 1 + 2 (F1 + 2)(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 (week 0))
- Concentration of Concizumab(Prior to the last dose administration after atleast 76 weeks)
- Occurrence of Anti-concizumab Antibodies 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 76 Weeks From Treatment Onset(During at least 76 weeks from treatment onset (week 0))
- Thrombin Generation Velocity Index(Prior to the last dose administration after atleast 76 weeks)