Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients (MDS)

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. Identifier: NCT01548495
Recruitment Status : Unknown
Verified March 2012 by yair levy, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 8, 2012
Last Update Posted : March 9, 2012
Information provided by (Responsible Party):
yair levy, Meir Medical Center

Brief Summary:
The purpose of this study is to verify the presents of autoantibodies in serums of MDS serum patients who had an inadequate response or did not respond to Recombinant human erythropoietin (rHuEPO) treatment.

Condition or disease
Myelodysplatic Syndrome

Detailed Description:
MDS are a heterogeneous group of hematologic disorders broadly characterized by cytopenias associated with a dimorphic and usually cellular bone marrow, and by consequent ineffective blood cell production. 85% of patients have a severe anemia which is Associated with lowering quality of life and Often requires blood transfusions. Historically, only stem cell transplantation offers cure. however, multiple new drugs have been approved for treatment, such as to Recombinant human erythropoietin (rHuEPO) treatment for dealing with the anemia. rHuEPO treatment can improve hematocrit level in 25% of patient which leaves the rest with the need of other treatment solution. Studies have shown presents of anti- rHuEPO in blood serums which followed Treatment of other diseases. These findings can indicate the possibility of the presence of antibodies in MDS patients as well.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients
Study Start Date : May 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Responded to rHuEPO treatment
response to EPO was defined as a rise in untransfused hemoglobin concentration of at least 2 g/dl or a 50% decrease in transfusion requirements over the treatment period
IR to rHuEPO treatment
No rise in hemoglobine consentration at normal and high dose rHuEPO treatment
Responded to high level rHuEPO
Responded to more than 80,000UI of rHuEPO treatment
No rHuEPO treatment

Primary Outcome Measures :
  1. Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment [ Time Frame: 1 year ]

    Response to Erythropoietine (EPO) was defined as a rise in untransfused hemoglobin concentration of at least 2 g/dl or a 50% decrease in transfusion requirements over the treatment period.

    Detection of Erythropoietin autoantibodies was performed by "Home-made ELISA" test.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MDS patient from meir health care center

Inclusion Criteria:

  • Followed up hematological patients
  • Pateint recieving rHuEPO treatment (except control group)
  • Pateint signed informed consent

Exclusion Criteria:

Information from the National Library of Medicine

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 identifier (NCT number): NCT01548495

Meir Medical center Not yet recruiting
Kfar- Saba, Israel, 44531
Contact: Yair Levy, prop    972-09-7472952   
Contact: yael hava eizikovits, mrs    972-0546573015   
Principal Investigator: yaei levy, prop         
Principal Investigator: yair levy, prop         
Sponsors and Collaborators
yair levy

Responsible Party: yair levy, director of internal medicin E department, Meir Medical Center Identifier: NCT01548495     History of Changes
Other Study ID Numbers: MDS-2011
First Posted: March 8, 2012    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by yair levy, Meir Medical Center:
Autoantibodies in MDS patients treated with EPO

Additional relevant MeSH terms:
Pathologic Processes
Epoetin Alfa
Immunologic Factors
Physiological Effects of Drugs