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临床试验/EUCTR2012-005768-90-BE
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)

Opsona Therapeutics Ltd0 个研究点目标入组 8 人开始时间: 2013年3月8日最近更新:
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  • - Withdrawn from OPN-305-102 prior to the 28-day final visit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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