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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 287
- 主要终点
- Days of Hospitalization During the Test Period
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •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
排除标准
- •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
结局指标
主要结局
Days of Hospitalization During the Test Period
时间窗: Weeks 1-12
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.
Number of Hospitalizations During the Test Period
时间窗: Weeks 1-12
Number of times participants were hospitalized as self-reported in the Health Care Utilization portion of the Subject Outcome Questionaire during Weeks 1-12
Number of Participants Hospitalized During the Test Period
时间窗: 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.
次要结局
- Hematopoietic Response During the Test Period(Weeks 1-12)
- Number of Units of Red Blood Cells Transfused During the Test Period(Weeks 1-12)
- Number of Days of Red Blood Cell Transfusions During Weeks 5-12(Weeks 5-12)
- Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13(Baseline (Week 1) and Week 13)
- Number of Units of Red Blood Cells Transfused During Weeks 5-12(Weeks 5-12)
- Hemoglobin Response During the Test Period(Weeks 1-12)
- Number of Days of Red Blood Cell Transfusions During the Test Period(Weeks 1-12)
- Number of Participants With Red Blood Cell (RBC) Transfusions During Weeks 5-12(Weeks 5-12)
- Number of Participants With Red Blood Cell (RBC) Transfusions During the Test Period(Weeks 1-12)
- Total Hospital Costs During the Test Period(Weeks 1-12)
- Change From Baseline in Hemoglobin Level(Baseline (Week 1) and Week 13)