Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients

NCT ID: NCT01548495

Last Updated: 2012-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Myelodysplatic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

IR to rHuEPO treatment

No rise in hemoglobine consentration at normal and high dose rHuEPO treatment

No interventions assigned to this group

Responded to high level rHuEPO

Responded to more than 80,000UI of rHuEPO treatment

No interventions assigned to this group

No rHuEPO treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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yair levy

OTHER

Sponsor Role lead

Responsible Party

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yair levy

director of internal medicin E department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Meir Medical center

Kfar Saba, Israel, Israel

Site Status

Countries

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Israel

Facility Contacts

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Yair Levy, prop

Role: primary

972-09-7472952

yael hava eizikovits, mrs

Role: backup

972-0546573015

Other Identifiers

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MDS-2011

Identifier Type: -

Identifier Source: org_study_id

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