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A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00095264
First Posted: November 3, 2004
Last Update Posted: January 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
November 2, 2004
November 3, 2004
January 15, 2010
October 2004
Not Provided
The proportion of subjects achieving an erythroid response during the 13-week test period
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Complete list of historical versions of study NCT00095264 on ClinicalTrials.gov Archive Site
  • The proportion of subjects achieving an erythroid response during the 28-week treatment period
  • The change in Hb from baseline
  • The incidence of red blood cell (RBC) transfusions (greater than or equal to 1 unit)
  • The change in FACT-F from baseline
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A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome
A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome
The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelodysplastic Syndromes
Drug: Darbepoetin Alfa
Not Provided
Gabrilove J, Paquette R, Lyons RM, Mushtaq C, Sekeres MA, Tomita D, Dreiling L. Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes. Br J Haematol. 2008 Jul;142(3):379-93. doi: 10.1111/j.1365-2141.2008.07181.x. Epub 2008 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
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Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10% determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times, ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit of the respective normal range) Ethical: - Must be 18 years of age or older - Provide written Institutional Review Board (IRB)-approved informed consent before any screening procedures are performed
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00095264
20030207
Not Provided
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Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP