NCT00111137已完成3 期
A Randomized, Open Label Study to Assess Time to Hemoglobin Response of a Front Load Dosing Regimen for Darbepoetin Alfa Compared to a Weekly Dose Regimen for Recombinant Human Erythropoietin in Patients With Non-Myeloid Malignancies Receiving Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 718
- 主要终点
- Time to hematopoietic response during the comparative treatment period
研究概览
简要总结
The purpose of this study is to compare the time to hematopoietic response (hemoglobin correction to 12 g/dL or a greater than or equal to 2 g/dL increase from baseline) for subjects randomized to receive darbepoetin alfa with a front load dosing regimen to those receiving recombinant human erythropoietin (rHuEPO) with a weekly dose regimen during the 12-week comparative treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects with non-myeloid malignancies planning to receive cyclic chemotherapy for 8 additional weeks or more
- •Anemia (hemoglobin [hgb] greater than or equal to 9.0g/dL and less than or equal to 11.0 g/dL) related to cancer and chemotherapy
- •Karnofsky performance status of greater than or equal to 50%
- •Serum bilirubin less than or equal to 2.5 times the upper limit of normal range and serum creatinine concentration of less than or equal to 2.0 mg/dL
排除标准
- •Acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes
- •Hematologic disorder previously associated with anemia
- •Active bleeding
- •Iron deficiency
- •Received erythropoietic therapy within 14 days prior to randomization
- •Unstable cardiac disease
- •Known positive human immunodeficiency virus antibody or hepatitis B surface antigen
- •Known positive antibody response to any erythropoietic agent
- •Currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial or is receiving investigational agent(s) not approved for any indication
- •Pregnant or breast feeding
- •Red blood cell (RBC) transfusion within 4 weeks of screening
- •Known hypersensitivity to any recombinant mammalian-derived product
研究组 & 干预措施
rHuEPO
Active Comparator
干预措施: rHuEPO (Drug)
Darbepoetin alfa
Experimental
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Time to hematopoietic response during the comparative treatment period
时间窗: during the comparative treatment period
次要结局
- Exploratory analyses for other patient reported outcome scales collected during the study (FACT-Anemia, BSI, EQ-5D, and Patient Satisfaction Questionnaire for Injectable Anemia Treatment)(during the study)
- Incidence, if any, of neutralizing antibody formation to study drug(throughout study)
- Difference between the average hemoglobin after the first month of treatment compared to the baseline hemoglobin(baseline to first month of treatment)
- Time to 2 g/dL increase in hemoglobin during the comparative treatment period(during the comparative treatment period)
- Change in FACT-Fatigue scale score over time during the comparative treatment period(during the comparative treatment period)
- Overall incidence of adverse events, serious adverse events and related adverse events as measured throughout study(throughout study)
- Slope of change in hemoglobin after the first month of treatment(baseline to first month of treatment)
- Red blood cell usage during the treatment period and other changes in hemoglobin during the comparative treatment period(during the comparative treatment period)
- Changes in hemoglobin during the maintenance period(during the maintenance period)
研究者
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