drugset / Trial / NCT02145026
A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase IV, prospective, multi-center, open-label study to assess the effectiveness and safety profile of epoetin beta (Recormon®) for treatment of symptomatic anemia in adult participants associated with low/intermediate-1-risk MDS. After screening, eligible participants will be treated with epoetin beta as recommended in the approved label and international guidelines for the use of epoetin in MDS participants and the dosage will be adjusted on the basis of erythroid response.
Timeline
- Start
- 2014-08-06
- Primary completion
- 2019-04-09
- Completion
- 2019-04-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | epoetin alfa | Protein / enzyme biologic | 30000 iu | Subcutaneous |
| Subject | epoetin alfa | Protein / enzyme biologic | 60000 iu | Subcutaneous |