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 Meir Medical Center.
Recruitment status was: Not yet recruiting
Information provided by (Responsible Party):
yair levy, Meir Medical Center
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients
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 ] [ Designated as safety issue: No ]
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:
| Study Start Date:
| Estimated Study Completion Date:
| 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
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)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
MDS patient from meir health care center
- Followed up hematological patients
- Pateint recieving rHuEPO treatment (except control group)
- Pateint signed informed consent
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01548495
|Meir Medical center
|Kfar- Saba, Israel, 44531 |
||yair levy, director of internal medicin E department, Meir Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 28, 2012
||March 8, 2012
||Israel: Ministry of Health
Keywords provided by Meir Medical Center:
Autoantibodies in MDS patients treated with EPO
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 17, 2017
Physiological Effects of Drugs