drugset / Trial / NCT00230321
A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objectives of the trial are to assess erythroid response to darbepoetin alfa, as determined by changes in hemoglobin and/or red blood cell (RBC) transfusion-dependence and to describe the safety profile of darbepoetin alfa in patients with MDS. The secondary objective is to assess bone marrow progenitor BFU-E growth before and after treatment with darbepoetin alfa.
Timeline
- Start
- 2002-02
- Primary completion
- 2007-11
- Completion
- 2008-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 4.5 ug/kg | Subcutaneous |
| Subject | Darbepoetin alfa | Protein / enzyme biologic | 9 ug/kg | Subcutaneous |