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临床试验/EUCTR2014-001429-33-PL
EUCTR2014-001429-33-PL进行中(未招募)1 期

Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacyof BMS-986004 in Adult Subjects with Primary Immune Thrombocytopenia (ITP)

Bristol-Myers Squibb International Corporation0 个研究点目标入组 80 人开始时间: 2015年10月9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
80

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

  • - > or equal to 18 years old, diagnosed with persistent or chronic ITP
  • - Patients must have received one or more ITP therapies and must have had initially responded to at least one prior ITP therapy
  • -Subjects have had relapsed ITP
  • -Platelet count must be less then 30,000/mm3 with no count greate than 35,000/mm3. If the mean of the counts is between 30,000-35,000/mm3, the subject may still be eligible but enrollment will be on a case by case basis and require approval by the Study Director.
  • 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 64
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 16

排除标准

  • - Secondary immune thrombocytopenia
  • - Drug induced thrombocytopenia
  • - History of MDS
  • - Subject exhibit an identifiable alternative cause of their thrombocytopenia.

研究者

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