Darbepoetin Alfa and Anemia of Cancer
NCT00989092 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287
Last updated 2014-01-29
Summary
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).
Conditions
Interventions
- BIOLOGICAL
-
darbepoetin alfa
Administered subcutaneously.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-05-31
- Primary Completion
- 2004-01-31
- Completion
- 2004-06-30
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