Darbepoetin Alfa and Anemia of Cancer

NCT00989092 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2014-01-29

Study results available
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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

  • Anemia
  • Anemia of Cancer
  • Cancer
  • Carcinoma
  • Neoplasms
  • Non-Myeloid Malignancies

Interventions

BIOLOGICAL

darbepoetin alfa

Administered subcutaneously.

Sponsors & Collaborators

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00989092 on ClinicalTrials.gov