To Study Efficacy and Outcome of Emicizumab Prophylaxis in Patients of Hemophilia A
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reducing bleeding events in haemophilia A patient
研究概览
简要总结
This study aims to assess Emicizumab’s efficacy and outcomes in managing Hemophilia A patient evaluating its safety and bleeding episode reduction. it’s a randomized controlled trial involving 66 patients. Patients will be categorized into group A)study group receiving Emicizumab and ,group B) control group receive other treatment like factor viii . assessment include annual bleeding events, laboratory analyses, and adverse event monitoring. Ultimately, the research aims to provide valuable insights into Emicizumab’s efficacy in managing Hemophilia A, potentially offering a safer and more effective treatment option for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •New Confirmed case of hemophilia A Patients with a documented baseline bleeding frequency, allowing for a comparison of bleeding episodes before and after emicizumab treatment Patients who give informed consent.
排除标准
- •Presence of coagulation disorders other than hemophilia A, which may confound the study results Significant comorbidities or medical conditions that may independently affect the outcomes of interest.
- •Like liver diseases Patients without proper informed consent.
结局指标
主要结局
Reducing bleeding events in haemophilia A patient
时间窗: 6 months
And evaluating efficacy of emicizumab
时间窗: 6 months
次要结局
- Reducing auto antibodies formation(1 months)
研究者
Dr Himani Dendor
Rnt medical College udaipur