Clinical Trials Directory

Trials / Terminated

TerminatedNCT00989092

Darbepoetin Alfa and Anemia of Cancer

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
287 (actual)
Sponsor
Amgen · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

TypeNameDescription
BIOLOGICALdarbepoetin alfaAdministered subcutaneously.

Timeline

Start date
2002-05-01
Primary completion
2004-01-01
Completion
2004-06-01
First posted
2009-10-02
Last updated
2014-01-29
Results posted
2014-01-29

Source: ClinicalTrials.gov record NCT00989092. Inclusion in this directory is not an endorsement.