EUCTR2012-005768-90-BE进行中(未招募)1 期
Follow-up Protocol to the Open-Label Phase 0 Part of the Phase II Opsona Study OPN-305-102 (A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody that Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Completion of the 28-day study visit in the open-label phase 0 of the phase II trial (OPN-305-102)
- •- Provide written informed consent for the follow-up protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •- Refusal to give written informed consent
- •- Withdrawn from OPN-305-102 prior to the 28-day final visit
- •- Plan to be included into another interventional investigational study
研究者
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