A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT00230321|
Recruitment Status : Completed
First Posted : September 30, 2005
Last Update Posted : February 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Blood Cancer Myelodysplastic Syndromes Myelodysplastic Syndromes (MDS)||Drug: Darbepoetin alfa||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Darbepoetin Alfa in Patients With Myelodysplastic Syndrome (MDS)|
|Study Start Date :||February 2002|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||January 2008|
Experimental: Darbepoetin alfa
During the induction phase, the investigational agent DARBEPOETIN ALFA will be initiated at a dose of 4.5 ug/kg/week subcutaneously for 6 weeks. The dosage for the remaining treatment is dependent of patients response during the induction phase.
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.
- hemoglobin and/or red blood cell (RBC) transfusion-dependence.
- To assess erythroid responses to DARBEPOETIN ALFA, as determined by changes in
- To assess bone marrow progenitor BFU-E growth before and after treatment
- DARBEPOETIN ALFA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230321
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Peter L Greenberg||Stanford University|