NCT00952575已完成2 期
A Phase II, Open-label, Randomised, Dose-finding Study to Compare the Efficacy (in Terms of Clearance of RhD-positive RBCs) and Safety of LFB-R593, a Monoclonal Anti-RhD Antibody vs a Polyclonal Anti-RhD Immunoglobulin in Healthy RhD Negative Volunteers
Laboratoire français de Fractionnement et de Biotechnologies1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Clearance of RhD-positive red blood cells
研究概览
简要总结
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing RhD-alloimmunisation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy RhD-negative volunteers
- •Males and definitively sterile females
- •No prior sensitization to RhD antigen
排除标准
- •Healthy RhD-positive volunteers
研究组 & 干预措施
polyclonal anti-D immunoglobulin
Active Comparator
干预措施: polyclonal anti-D immunoglobulin (Drug)
Monoclonal anti-D immunoglobulin
Experimental
干预措施: monoclonal anti-D immunoglobulin (Drug)
结局指标
主要结局
Clearance of RhD-positive red blood cells
时间窗: within 2 weeks after RBC injection
次要结局
未报告次要终点
研究者
研究点 (1)
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