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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by yair levy, Meir Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
yair levy, Meir Medical Center Identifier:
First received: February 28, 2012
Last updated: March 8, 2012
Last verified: March 2012
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.

Myelodysplatic Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by yair levy, Meir Medical Center:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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

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.

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:

  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: yair levy, director of internal medicin E department, Meir Medical Center Identifier: NCT01548495     History of Changes
Other Study ID Numbers: MDS-2011
Study First Received: February 28, 2012
Last Updated: March 8, 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 processed this record on June 23, 2017