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临床试验/EUCTR2014-003265-19-PL
EUCTR2014-003265-19-PL进行中(未招募)1 期

A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839

Genzyme Corporation0 个研究点目标入组 168 人开始时间: 2015年2月26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
168

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

  • Patients who completed the 12-week treatment period in DRI13839.
  • 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 168
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient’s participation in the long-term extension study.
  • Confirmed platelet count below the lower limit of normal at any time during DRI13839.
  • Pregnancy or breast-feeding.

研究者

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Efficacy and Safety of Vatelizumab in Patients Who... | 临床试验