Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients (MDS)
Recruitment status was Not yet recruiting
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.
|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|
- 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.
|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|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548495
|Meir Medical center||Not yet recruiting|
|Kfar- Saba, Israel, 44531|
|Contact: Yair Levy, prop 972-09-7472952 firstname.lastname@example.org|
|Contact: yael hava eizikovits, mrs 972-0546573015 email@example.com|
|Principal Investigator: yaei levy, prop|
|Principal Investigator: yair levy, prop|