Darbepoetin Alfa and Anemia of Cancer
2013年12月11日 更新者：Amgen
A Randomized, Open-label, Comparative Study to Estimate the Effect of Darbepoetin Alfa on Hospital Days, Economic Outcomes, and Health-related Quality of Life in Subjects With Nonmyeloid Malignancies and Anemia of Cancer
This phase 2, multicenter, randomized, open-label, comparative study was designed to determine the effect of darbepoetin alfa on hospital days, economic outcomes, and health related quality of life (HRQOL) in anemic patients with nonmyeloid malignancies who were not receiving chemotherapy.
Participants were randomly assigned in a 4:1 allocation ratio to receive either 21 weeks of darbepoetin alfa treatment (treatment group) or 12 weeks of observation followed by up to 9 weeks of darbepoetin alfa treatment (observation group).
研究概览
研究类型
介入性
注册 (实际的)
287
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- nonmyeloid malignancies (including lymphocytic leukemias)
- anemia (hemoglobin concentration less than or equal to 11.0 g/dL) due to cancer and/or previous chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group performance status of 0 to 2
- adequate liver and renal functions
- 18 years or older
Exclusion Criteria:
- history of recombinant human erythropoietin therapy, cytotoxic chemotherapy, or more than 30 Gy radiotherapy to the whole pelvis within 4 weeks before screening
- acute myelogenous leukemia, chronic myelogenous leukemia, or myelodysplastic syndrome
- known hematologic disorders that could cause anemia
- inflammatory or cardiac disorders
- previous positive antibody response to any erythropoietic agent
- history of pure red cell aplasia
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Observational Group
Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period).
No darbepoetin alfa was administered to the observation group during this period.
Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL.
The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
|
Administered subcutaneously.
其他名称：
|
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有源比较器：21 week treatment group
Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks.
The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
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Administered subcutaneously.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants Hospitalized During the Test Period
大体时间：Weeks 1- 12
|
Number of participants hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire.
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Weeks 1- 12
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Days of Hospitalization During the Test Period
大体时间：Weeks 1-12
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Number of days hospitalized during Weeks 1-12 as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire; participants who were not hospitalized had a value of 0 days.
|
Weeks 1-12
|
|
Number of Hospitalizations During the Test Period
大体时间：Weeks 1-12
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Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12
|
Weeks 1-12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Hospital Costs During the Test Period
大体时间：Weeks 1-12
|
The hospital bill database was used to determine the mean total hospital cost per participant during the test period.
Participants who were not hospitalized had a cost of $0 imputed.
|
Weeks 1-12
|
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Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
大体时间：Baseline (Week 1) and Week 13
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The FACT-Fatigue scale comprises 13 questions evaluating the impact of anemia on cancer patients with various tumor types receiving chemotherapy.
Fatigue scores range from 0 to 52, with a higher score indicating less fatigue.
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Baseline (Week 1) and Week 13
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Hemoglobin Response During the Test Period
大体时间：Weeks 1-12
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The number of participants achieving a hemoglobin response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
|
Weeks 1-12
|
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Hematopoietic Response During the Test Period
大体时间：Weeks 1-12
|
The number of participants achieving a hematopoietic response, defined as an increase in hemoglobin from baseline of ≥ 2.0 g/dL or a concentration ≥ 12.0 g/dL both in the absence of red blood cell (RBC) transfusions during the preceding 28 days.
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Weeks 1-12
|
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Change From Baseline in Hemoglobin Level
大体时间：Baseline (Week 1) and Week 13
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The difference between hemoglobin concentrations after 12 weeks of treatment and the Baseline hemoglobin concentration value (Study Day 1 sample prior to first dose of darbepoetin alfa).
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Baseline (Week 1) and Week 13
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Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period
大体时间：Weeks 1-12
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Number of participants with at least one RBC transfusion during Weeks 1 to 12.
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Weeks 1-12
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Number of Units of Red Blood Cells Transfused During the Test Period
大体时间：Weeks 1-12
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The average number of standard units of red blood cells transfused during Weeks 1 to 12.
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Weeks 1-12
|
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Number of Days of Red Blood Cell Transfusions During the Test Period
大体时间：Weeks 1-12
|
The number of days when at least one red blood cell transfusion was administered during Weeks 1 to 12.
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Weeks 1-12
|
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Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12
大体时间：Weeks 5-12
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The number of participants with at least one RBC transfusion during weeks 5 to 12.
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Weeks 5-12
|
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Number of Units of Red Blood Cells Transfused During Weeks 5-12
大体时间：Weeks 5-12
|
The number of standard units of RBCs transfused during Weeks 5 to 12.
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Weeks 5-12
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Number of Days of Red Blood Cell Transfusions During Weeks 5-12
大体时间：Weeks 5-12
|
The number of days when at least one RBC transfusion was administered during Weeks 5 to 12.
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Weeks 5-12
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2002年5月1日
初级完成 (实际的)
2004年1月1日
研究完成 (实际的)
2004年6月1日
研究注册日期
首次提交
2009年10月1日
首先提交符合 QC 标准的
2009年10月1日
首次发布 (估计)
2009年10月2日
研究记录更新
最后更新发布 (估计)
2014年1月29日
上次提交的符合 QC 标准的更新
2013年12月11日
最后验证
2013年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.