NCT00118638已完成3 期
A Randomized, Double Blind, Active-Controlled Study of Darbepoetin Alfa for the Treatment of Anemia in Subjects With Non-Myeloid Malignancy Receiving Multicycle 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
- 705
- 主要终点
- Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of darbepoetin alfa as 500ug once every 3 weeks to show that the dose and schedule are not inferior to darbepoetin alfa administered as 2.25ug/kg once per week in the treatment of anemia in subjects with non-myeloid malignancies.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Non-myeloid malignancy
- •At least 12 additional weeks of cyclic cytotoxic chemotherapy anticipated regardless of schedule
- •Eastern Cooperative Oncology Group performance status of 0-2
- •Hemoglobin concentration of less than 11 g/dL within 24 hours before randomization
- •Of legal age at the time written informed consent is obtained
排除标准
- •Known history of seizure disorder
- •Known primary hematologic disorder, which could cause anemia, other than a non-myeloid malignancy
- •Unstable or uncontrolled disease/condition, related to or affecting cardiac function
- •Clinically significant inflammatory disease
- •Inadequate renal and/or liver function
- •Known positive HIV test
- •Previously suspected of or confirmed to have neutralizing antibodies to rHuEPO
- •Received more than 2 red blood cell (RBC) transfusions within 4 weeks before randomization or any RBC transfusion within 14 days before randomization, or any planned RBC transfusion between randomization and study day 1
- •Received any erythropoietic therapy within 4 weeks before randomization or any planned erythropoietic therapy between randomization and study day 1
- •Other investigational procedures
- •Subject is currently enrolled in or less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
- •Pregnant or breast feeding
- •Not using adequate contraceptive precautions
- •Known sensitivity to any of the products to be administered during dosing
- •Previously randomized in this study
- •Concerns for subject's compliance with protocol procedures
研究组 & 干预措施
Darbepoetin alfa 500 mcg - Group A
Experimental
干预措施: Darbepoetin alfa - 500mcg (Drug)
Darbepoetin alfa 2.25 mcg/kg - Group B
Active Comparator
干预措施: Darbepoetin alfa - 2.25 mcg/kg (Drug)
结局指标
主要结局
Incidence of at least one RBC transfusion from week 5 to End of Treatment Period (EOTP)
时间窗: from week 5 to EOTP
次要结局
- Incidence of achieving a hemoglobin concentration of greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 5 to EOTP(from week 5 to EOTP)
- Incidence of at least one RBC transfusion from week 1 (day 1) to EOTP(from week 1 (day 1) to EOTP)
- Incidence of achieving a hemoglobin concentration greater than or equal to 11.0 g/dL, in the absence of RBC transfusions in the preceding 28 days, from week 1 to EOTP(from week 1 to EOTP)
- Change in FACT-G Physical Well-being subscale from baseline to EOTP(from baseline to EOTP)
- Change in hemoglobin from baseline to EOTP(from baseline to EOTP)
- Change in FACT-Fatigue subscale score from baseline to EOTP(from baseline to EOTP)
- Change in FACT-G total score from baseline to EOTP(from baseline to EOTP)
- Change in EQ-5D Thermometer from baseline to EOTP(from baseline to EOTP)
- Change in BSI Anxiety scale score from baseline to EOTP(from baseline to EOTP)
- Change in BSI Depression scale score from baseline to EOTP(from baseline to EOTP)
- Incidence and severity of adverse events(throughout study)
- Incidence of hemoglobin concentration greater than 13.0 g/dL at any time on study(at any time on study)
- Change in number of caregiver hours from baseline to EOTP(from baseline to EOTP)
- Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dL in a 28-day window and any negative clinical consequences(throughout study)
- Incidence of an increase in hemoglobin concentration of greater than or equal to 1 g/dL in a 14-day window and any negative clinical consequences(throughout study)
- Incidence of a confirmed antibody formation to darbepoetin alfa(throughout study)
研究者
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