drugset / Trial / NCT02145026

A Study of Epoetin Beta Treatment in Anemic Participants With Myelodysplastic Syndrome (MDS)

NCT02145026

Phase 4 Completed 100 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject epoetin alfa Protein / enzyme biologic 30000 iu Subcutaneous
Subject epoetin alfa Protein / enzyme biologic 60000 iu Subcutaneous