Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT01548495
Status:
UNKNOWN
Last Update Posted:
2012-03-09
First Post:
2012-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-08-15', 'releaseDate': '2017-11-08'}], 'estimatedResultsFirstSubmitDate': '2017-11-08'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-08', 'studyFirstSubmitDate': '2012-02-28', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlate the Presence of Erythropoietin autoantibodies titer in MDS patients with an inadequate response (IR) to Human Recombinant Erythropoietin treatment', 'timeFrame': '1 year', 'description': '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.\n\nDetection of Erythropoietin autoantibodies was performed by "Home-made ELISA" test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MDS', 'Autoantibodies', 'Erythropoietin', 'Autoantibodies in MDS patients treated with EPO'], 'conditions': ['Myelodysplatic Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MDS patient from meir health care center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Followed up hematological patients\n* Pateint recieving rHuEPO treatment (except control group)\n* Pateint signed informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01548495', 'acronym': 'MDS', 'briefTitle': 'Autoantibodies Against Human Recombinant Erythropoietin in Myelodysplatic Syndrome Patients', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Investigating Recombinant Human Erythropoietin (rHuEPO) Treatment Efficacy Depending on the Presence of Erythropoietin Autoantibodies in Myelodysplatic Syndrome (MDS) Patients', 'orgStudyIdInfo': {'id': 'MDS-2011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Responded to rHuEPO treatment', 'description': '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'}, {'label': 'IR to rHuEPO treatment', 'description': 'No rise in hemoglobine consentration at normal and high dose rHuEPO treatment'}, {'label': 'Responded to high level rHuEPO', 'description': 'Responded to more than 80,000UI of rHuEPO treatment'}, {'label': 'No rHuEPO treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44531', 'city': 'Kfar Saba', 'state': 'Israel', 'country': 'Israel', 'contacts': [{'name': 'Yair Levy, prop', 'role': 'CONTACT', 'email': 'levy.yair@clalit.org.il', 'phone': '972-09-7472952'}, {'name': 'yael hava eizikovits, mrs', 'role': 'CONTACT', 'email': 'yael.eizikovits@clalit.org.il', 'phone': '972-0546573015'}, {'name': 'yaei levy, prop', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'yair levy, prop', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'yair levy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'director of internal medicin E department', 'investigatorFullName': 'yair levy', 'investigatorAffiliation': 'Meir Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-11-08', 'type': 'RELEASE'}, {'date': '2018-08-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'yair levy, director of internal medicin E department, Meir Medical Center'}}}}