NCT00095264
Completed
Phase 2
A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome
ConditionsMyelodysplastic Syndromes
DrugsDarbepoetin Alfa
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- Amgen
- Enrollment
- 209
- Primary Endpoint
- The proportion of subjects achieving an erythroid response during the 13-week test period
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The proportion of subjects achieving an erythroid response during the 13-week test period
Secondary Outcomes
- The proportion of subjects achieving an erythroid response during the 28-week treatment period
- The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit)
- The change in FACT-F from baseline
- The change in Hb from baseline
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