Study Complete
Sponsor ID
20010199
Chemotherapy Related Anemia
Study Details
This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously).
Protocol Summary
Primary Outcome Measures
Change in hemoglobin concentration measured from baseline to the end of treatment period (EOTP)
Timeframe: from baseline to the end of treatment period (EOTP)
Secondary Outcome Measures
Percentage of subjects who have a rapid rise in hemoglobin concentration; negative clinical consequences potentially associated with this rise evaluated in subjects with and without a rapid rise in hemoglobin concentration
Timeframe: throughout study
Change in hemoglobin concentration measured from baseline to week 7 and from week 7 to EOTP
Timeframe: from baseline to week 7 and from week 7 to EOTP
Time to and percentage of subjects who achieve hemoglobin improvement during the treatment period
Timeframe: during the treatment period
Time to and percentage of subjects with a hemoglobin response during the treatment period
Timeframe: during the treatment period
Percentage of subjects who exceed the hemoglobin threshold
Timeframe: throughout study
Incidence of all adverse events, serious adverse events, and severe or life-threatening adverse events
Timeframe: throughout study
Incidence, if any, of neutralizing antibody formation to darbepoetin alfa
Timeframe: throughout study
Locations
No locations found.