Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients

Myelodysplatic Syndrome Clinical Trial

— MDS  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01548495
• Other study ID #: MDS-2011
• Status: Unknown status
• Phase: N/A
• First received: February 28, 2012
• Last updated: March 8, 2012
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Followed up hematological patients

• Pateint recieving rHuEPO treatment (except control group)

• Pateint signed informed consent

Exclusion Criteria:

Related Conditions & MeSH terms

• Myelodysplatic Syndrome
• Syndrome

Locations

Country	Name	City	State
Israel	Meir Medical center	Kfar- Saba

Sponsors (1)

Lead Sponsor	Collaborator
yair levy

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment	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.	1 year