CTRI/2009/091/000027已完成4 期
An Open, Prospective, Non-comparative, Multicenter Study to Estimate the recovery after a single infusion of Human Factor VIII Factocel 250 I.U. in patients of Haemophilia A
Celestial Biologics Limited0 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
- 已完成
- 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
- •1.Moderate to severe Haemophilia A (defined as ≤ 5% of normal factor VIII)
- •2.Age ≥ 18 years
- •3.Absence of FVIII infusion within 7 days prior to enrollment in the study
- •4.No current bleeding
- •5.Patient able to provide written informed consent
排除标准
- •1.Any haemorrhagic disorder other than Haemophilia A.
- •2.Past or present history of FVIII inhibitors
- •3.History of anaphylactic reaction to human FVIII
- •4.Major renal or hepatic dysfunction,
- •5.Participation in a clinical trial within 30 days prior to recruitment and during the study, in another investigational drug study that clinically interferes with the study endpoints
- •6.Any clinically significant disorder which could affect the evaluation or the patient?s safety.
研究者
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