EUCTR2006-006147-31-IT进行中（未招募）不适用
An open multicenter clinical trial to evaluate the safety, tolerability and efficacy of Deferasirox (ICL670) in patients affected by Myelodysplastic syndrome and transfusional chronic hemosiderosis. - GIMEMA MDS 0306
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 个研究点开始时间: 2007年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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, both males and females, with low and intermediate I risk (IPSS score) Myelodysplastic syndrome and transfusion-induced hemosiderosis.
- •?Age >=18 years
- •?Patients who never received chelation therapy or who received a therapy with Desferal after a day of wash out
- •?Medical history of at least 20 blood transfusions (equivalent to 100 ml/kg of red cells concentrate).
- •?Availability of data concerning blood transfusions during the 12 weeks before screening
- •?Serum ferritin >= 1000 ?g/L at least twice (at least 2 week interval between the 2 analysis) during the year before the screening
- •?Life expectancy > 12 months
- •?Availability of at least 3 complete blood counts (before transfusions) during the 12 weeks before the screening
- •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
- •?Diagnosis different from MDS (i.e. mielofibrosis)
- •?Severe renal impairment (creatinine clearance < 60 ml/min)
- •?ALT/AST > 500 U/L
- •?Active B and/or C hepatitis
- •?Patients treated during the past 4 weeks with experimental drugs for MDS (including thalidomide, azacitidine, arsenic trioxide). These patients become eligible after a ?wash out? of at least 4 weeks
- •?Concomitant treatment with another iron-chelating agent
研究者
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