NCT00805909已完成1 期
A Phase IIa, Open-Label, Dose-Titration, Multicenter Study to Assess the Safety and Preliminary Efficacy of NI-0401 in Patients With Acute Cellular Renal Allograft Rejection
Light Chain Bioscience - Novimmune SA1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Nature,frequency,intensity,causality and seriousness of adverse events
研究概览
简要总结
The purpose of the study is to determine the safety and tolerability of NI-0401 and whether NI-0401 can reverse BpACR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •previous therapy with anti-CD3 mAB(OKT3) or anti-lymphocytes polyclonal antibodies (ATG, Atgam)
- •patients with cardiac insufficiency or fluid overload
- •severe HLA sensitization (>50% panel reactive antibodies prior transplantation)
- •defined concomitant disease
研究组 & 干预措施
NI-0401
Experimental
5 daily infusions of escalating doses of NI-0401
干预措施: NI-0401 (Drug)
结局指标
主要结局
Nature,frequency,intensity,causality and seriousness of adverse events
时间窗: Studay day 1 to week 6
次要结局
未报告次要终点
研究者
研究点 (1)
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