A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

Amgen0 个研究点目标入组 209 人开始时间: 2004年10月1日最近更新: 2010年1月15日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Amgen
入组人数: 209
主要终点: The proportion of subjects achieving an erythroid response during the 13-week test period

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

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

入选标准

•Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10% determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times, ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit of the respective normal range) Ethical: - Must be 18 years of age or older - Provide written Institutional Review Board (IRB)-approved informed consent before any screening procedures are performed

排除标准

未提供

结局指标

主要结局

The proportion of subjects achieving an erythroid response during the 13-week test period

次要结局

The proportion of subjects achieving an erythroid response during the 28-week treatment period
The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit)
The change in FACT-F from baseline
The change in Hb from baseline

研究者

发起方

Amgen

申办方类型

Industry

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