Darbepoetin Alfa MDS Companion Protocol

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is a phase 3b, multi-centre, open-label, single-arm companion study to the MDS 20090160 study (NCT01362140) for the treatment of anaemic patients with MDS. Participants who completed the active-treatment period of the darbepoetin alfa MDS 20090160 study and met the eligibility criteria could be enrolled into this study to continue treatment of darbepoetin alfa for up to 73 weeks or until progression to acute myelogenous leukemia (AML), whichever occurs first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02175277
Study type	Interventional
Source	Amgen
Contact
Status	Completed
Phase	Phase 3
Start date	June 12, 2014
Completion date	March 20, 2017

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