Trial intelligence / Profile preview

Darbepoetin alfa for anemia in non-myeloid malignancy chemotherapy

NCT00110955Phase 3

Key facts

Status: Completed
Start: Feb 2004
Primary completion: Mar 2005
Sponsor: Amgen
Modality: Erythropoietins, Colony Stimulating Factors

Drugs: darbepoetin alfa
Conditions: anemia

Overview

Phase 3, randomised, double-blind trial in anemia comparing Darbepoetin alfa with Placebo (2 arms). Primary endpoint: Incidence of red blood cell (RBC) transfusion. Started Feb 2004; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Darbepoetin alfa
Darbepoetin alfa 300 mcg Q3W
Placebo
Placebo Q3W

Who it enrols

Adult patients with non-myeloid malignancy receiving multicycle chemotherapy with hemoglobin < 11.0 g/dL.

Endpoints

Primary

Incidence of red blood cell (RBC) transfusionWeek 5 to EOTP

Secondary

Incidence of achieving a hemoglobin concentration of greater than or equal to 11 g/dLWeek 5 to EOTP
Number of RBC transfusionsWeek 5 to EOTP
Change in FACT-Fatigue subscale scoreBaseline to EOTP
Change in FACT-G Physical Well-being subscaleBaseline to EOTP
Incidence and severity of adverse eventsThroughout study
Incidence of hemoglobin concentration greater than 13.0 g/dLAny time on study
Change in FACT-G total scoreBaseline to EOTP
Incidence of an increase in hemoglobin concentration greater than or equal to 2 g/dLThroughout study

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