跳至主要内容
临床试验/NCT01548495
NCT01548495Unknown不适用

Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients

yair levy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
发起方
yair levy
入组人数
100
试验地点
1
主要终点
Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment

研究概览

简要总结

The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum patients who had an inadequate response or did not respond to Recombinant human erythropoietin (rHuEPO) treatment.

详细描述

MDS are a heterogeneous group of hematologic disorders broadly characterized by cytopenias associated with a dimorphic and usually cellular bone marrow, and by consequent ineffective blood cell production. 85% of patients have a severe anemia which is Associated with lowering quality of life and Often requires blood transfusions. Historically, only stem cell transplantation offers cure. however, multiple new drugs have been approved for treatment, such as to Recombinant human erythropoietin (rHuEPO) treatment for dealing with the anemia. rHuEPO treatment can improve hematocrit level in 25% of patient which leaves the rest with the need of other treatment solution. Studies have shown presents of anti- rHuEPO in blood serums which followed Treatment of other diseases. These findings can indicate the possibility of the presence of antibodies in MDS patients as well.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Followed up hematological patients
  • Pateint recieving rHuEPO treatment (except control group)
  • Pateint signed informed consent

排除标准

  • 未提供

结局指标

主要结局

Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment

时间窗: 1 year

Response to Erythropoietine (EPO) was defined as a rise in untransfused hemoglobin concentration of at least 2 g/dl or a 50% decrease in transfusion requirements over the treatment period. Detection of Erythropoietin autoantibodies was performed by "Home-made ELISA" test.

次要结局

未报告次要终点

研究者

发起方
yair levy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yair levy

director of internal medicin E department

Meir Medical Center

研究点 (1)

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