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Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients

Information source: Meir Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myelodysplatic Syndrome

Phase: N/A

Status: Not yet recruiting

Sponsored by: yair levy

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Followed up hematological patients

- Pateint recieving rHuEPO treatment (except control group)

- Pateint signed informed consent

Exclusion Criteria:

- None

Locations and Contacts

Meir Medical center, Kfar- Saba 44531, Israel; Not yet recruiting
Yair Levy, prop, Phone: 972-09-7472952, Email: levy.yair@clalit.org.il
yael hava eizikovits, mrs, Phone: 972-0546573015, Email: yael.eizikovits@clalit.org.il
yaei levy, prop, Principal Investigator
yair levy, prop, Principal Investigator
Additional Information

Starting date: May 2012
Last updated: March 8, 2012

Page last updated: August 20, 2015

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