CTRI/2024/01/061593招募中4 期
Evaluation of efficacy and safety of low dose versus standard dose Emicizumab for the treatment of Hemophilia A – A randomized controlled trial - Nil
Department of Health Research, India0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •All persons with haemophilia A(PWH)with FVIII levels less than 2 percentage as seen in case notes with age ranging from 2 to 17 years
- •PWH with and without the presence of FVIII inhibitors
- •PWH with inhibitors not planning for immune tolerance induction or where immune
- •tolerance induction has failed
- •PWH with hepatitis and HIV
- •Parents or patients willing to signed and give written informed consent or assent as
- •appropriate
- •Children and caregivers willing to comply with scheduled visits, treatment plans, laboratory
- •tests, and other study procedures, including the questionnaires.
- •Written or verbal assent as appropriate from children participating in the study
排除标准
- •Patients who will find it difficult to follow the protocol based on PI judgement
- •Patients posted for elective surgery
- •Inherited or acquired bleeding disorder other than hemophilia A
- •Ongoing Immune tolerance Induction therapy (prophylaxis regimens with FVIII and or
- •bypassing agents must be discontinued prior to enrollment)
研究者
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