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临床试验/IRCT20210523051368N1
IRCT20210523051368N1招募中3 期

Evaluating overall survival and the rate of GVHD in children and adolescents receiving antithymocyte globulin as an immunosuppressant during hematopoietic stem cell transplantation

Kowsar Biotechnology company0 个研究点目标入组 45 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
45

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
1 year 至 18 years(—)
性别
All

入选标准

  • 1 to 18 year-old hematopoietic stem cell transplant recipients with anti-thymocyte globulin in their conditioning regimen
  • parents or legally acceptable representatives must have provided a written informed consent
  • Lansky score above 70%
  • Absence of severe active infection
  • use of bone marrow or G-CSF-stimulated peripheral blood stem cells

排除标准

  • History of previous stem cell transplantation (re-transplantation)
  • use of umbilical cord blood stem cells
  • history of previous treatment with anti-thymocyte globulin in the last three months
  • Known allergic reaction to rabbit proteins
  • abnormal liver function (total bilirubin greater than three times the upper limit of normal (ULN), conjugated bilirubin> 2 mg/dl, transaminases greater than three times the ULN)
  • abnormal renal function adjusted for the patient's age
  • abnormal heart function (left ventricular ejection fraction < 50% after ECHO, congestive heart failure, arrhythmia)

研究者

发起方
Kowsar Biotechnology company

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