drugset / Trial / NCT02175277

Darbepoetin Alfa MDS Companion Protocol

NCT02175277

Phase 3 Completed 9 enrolled Amgen
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of the study was to provide required access of investigational product (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient population.

Timeline

Start
2014-06-12
Primary completion
2017-03-20
Completion
2017-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Darbepoetin alfa Protein / enzyme biologic 500 ug