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临床试验/EUCTR2009-011161-87-FR
EUCTR2009-011161-87-FR进行中(未招募)不适用

Treatment of anemia in myelodysplastic syndromes low risk with epoetin beta with Analysis of impact on quality of life and functional capacity - GFM-EPO-Qo

Groupe Francophone des Myélodysplasies0 个研究点开始时间: 2009年11月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)

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

  • Written informed consent;
  • Must be 18 years of age or older at the time of screening ;
  • Myelodysplastic Syndrome of the following subtypes : RA, RAS, RCMD, RCMD-RS, RAEB 1, with IPSS score low or intermediate 1 (IPSS score < 1 ) and with anemia defined by Hb < 10 g/dl (with RBC transfusion requirement or not);
  • For women of childbearing potential, need for effective contraception throughout the study period.
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Intensive Chemotherapy within 3 months before inclusion;
  • Myelodysplastic Syndrome with IPSS score >1 ;
  • Treatment with rHu-Epo or rHu-GCSF within 2 months before inclusion
  • Other causes of anemia (eg. , Iron deficiency, vitamin B12 or folic acid, hypothyroidism before correction)
  • Uncontrolled arterial hypertension
  • Life expectancy less than 6 months
  • Pregnant or breast feeding female subjects
  • Patients with creatinine clearance less than 30ml/min

研究者

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