Darbepoetin Alfa and Anemia of Cancer
2013년 12월 11일 업데이트: 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).
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연구 유형
중재적
등록 (실제)
287
단계
- 2 단계
참여기준
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자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
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아니
연구 대상 성별
모두
설명
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
공부 계획
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디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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.
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Administered subcutaneously.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Hospitalized During the Test Period
기간: Weeks 1- 12
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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
기간: 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.
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Weeks 1-12
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Number of Hospitalizations During the Test Period
기간: 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
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Weeks 1-12
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total Hospital Costs During the Test Period
기간: Weeks 1-12
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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.
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Weeks 1-12
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Change in Functional Assessment of Cancer Therapy (FACT)-Fatigue Score at Week 13
기간: 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
기간: 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.
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Weeks 1-12
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Hematopoietic Response During the Test Period
기간: Weeks 1-12
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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
기간: 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
기간: 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
기간: 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
기간: Weeks 1-12
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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
기간: 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
기간: Weeks 5-12
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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
기간: Weeks 5-12
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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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연구 주요 날짜
연구 시작
2002년 5월 1일
기본 완료 (실제)
2004년 1월 1일
연구 완료 (실제)
2004년 6월 1일
연구 등록 날짜
최초 제출
2009년 10월 1일
QC 기준을 충족하는 최초 제출
2009년 10월 1일
처음 게시됨 (추정)
2009년 10월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 1월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2013년 12월 11일
마지막으로 확인됨
2013년 12월 1일
추가 정보
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