Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients (MDS)
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Purpose
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.
| Condition |
|---|
|
Myelodysplatic Syndrome |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 100 |
| 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) |
| Groups/Cohorts |
|---|
|
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 |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
MDS patient from meir health care center
Inclusion Criteria:
- Followed up hematological patients
- Pateint recieving rHuEPO treatment (except control group)
- Pateint signed informed consent
Exclusion Criteria:
- None
Contacts and Locations| Israel | |
| Meir Medical center | Not yet recruiting |
| Kfar- Saba, Israel, 44531 | |
| Contact: Yair Levy, prop 972-09-7472952 levy.yair@clalit.org.il | |
| Contact: yael hava eizikovits, mrs 972-0546573015 yael.eizikovits@clalit.org.il | |
| Principal Investigator: yaei levy, prop | |
| Principal Investigator: yair levy, prop | |
More Information
No publications provided
| Responsible Party: | yair levy, director of internal medicin E department, Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT01548495 History of Changes |
| Other Study ID Numbers: | MDS-2011 |
| Study First Received: | February 28, 2012 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Meir Medical Center:
|
MDS Autoantibodies Erythropoietin Autoantibodies in MDS patients treated with EPO |
Additional relevant MeSH terms:
|
Autoantibodies Epoetin Alfa Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013