Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients

Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01548495

Acronym

MDS

Enrollment

100

Registered

2012-03-08

Start date

2012-05-31

Completion date

2013-09-30

Last updated

2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplatic Syndrome

Keywords

MDS, Autoantibodies, Erythropoietin, Autoantibodies in MDS patients treated with EPO

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment	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.

Countries

Israel

Outcome results