NCT00230321

A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Peter L Greenberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Cancer
• Myelodysplastic Syndromes
• Myelodysplastic Syndromes (MDS)

Interventions

Type	Name	Description
DRUG	Darbepoetin alfa	During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously.If patients do not achieve a major erythroid response by 6 weeks, the dose of DARBEPOETIN ALFA will be doubled to 9.0 ug/kg/week.

Timeline

• Start date: 2002-02-01
• Primary completion: 2007-11-01
• Completion: 2008-01-01
• First posted: 2005-09-30
• Last updated: 2013-02-04

Locations

1 site across 1 country: United States