Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 11:58 PM
Study NCT ID:
NCT00452660
Status:
COMPLETED
Last Update Posted:
2014-06-16
First Post:
2007-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077588', 'term': 'Deferasirox'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-13', 'studyFirstSubmitDate': '2007-03-26', 'studyFirstSubmitQcDate': '2007-03-26', 'lastUpdatePostDateStruct': {'date': '2014-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the antioxidative effect of Exjade therapy in MDS patients', 'timeFrame': 'one year'}, {'measure': 'with iron over load by evaluating oxidative stress parameters', 'timeFrame': 'one year'}, {'measure': 'pre and post treatment', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of Exjade over the treatment period.', 'timeFrame': 'one year'}, {'measure': 'To analyze iron overload after Exjade treatment period.', 'timeFrame': 'one year'}, {'measure': 'To evaluate transfusion requirements.', 'timeFrame': 'one year'}, {'measure': 'To confirm the value of LPI, LIP, and Hepcidin as a marker for accurate monitoring of chelation therapy in MDS patients with iron over load.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IRON', 'oxidative stress', 'MDS'], 'conditions': ['Myelodysplastic Syndrome']}, 'referencesModule': {'references': [{'pmid': '20421274', 'type': 'DERIVED', 'citation': 'Ghoti H, Fibach E, Merkel D, Perez-Avraham G, Grisariu S, Rachmilewitz EA. Changes in parameters of oxidative stress and free iron biomarkers during treatment with deferasirox in iron-overloaded patients with myelodysplastic syndromes. Haematologica. 2010 Aug;95(8):1433-4. doi: 10.3324/haematol.2010.024992. Epub 2010 Apr 26. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found to be increased in MDS patients and consequently resulted in ineffective hematopoiesis. The aim of this study is to evaluate the antioxidant effect of the oral iron chelator Deferasirox -Exjade in low risk MDS patients with iron over load by evaluating changes in several oxidative stress parameters Certain percentage of MDS patients develop iron overload.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with myelodysplastic syndrome with an IPSS score being Intermediate-1 or low.\n* Patients who already received ≥20 unit (100 mL/kg) of packed red blood cells and showing evidence of iron overload (serum ferritin \\>1000 µg/L).\n* Patients post stem cells transplantation with disease recurrence with MDS IPSS score low or intermediate 1.\n* Patients who have given consent personally in writing\n\nExclusion Criteria:\n\n* Patients with myelodysplastic syndrome with an IPSS score being Intermediate-2 or High.\n* Patients with serum creatinine \\>2.0 x ULN\n* Patients with ALT(SGPT) levels \\> 5 x ULN\n* Significant proteinuria as indicated by a urinary protein/creatinine ratio \\>0.5 mg/mg in a non-first void urine sample on two assessments during the screening period.\n* History of HIV positive test result. When there are any signs or symptoms indicative of the disease even if the diagnosis is not made, additional test should be conducted.\n* History of clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above the normal range)\n* Patients with systemic uncontrolled hypertension\n* Patients with unstable cardiac disease not controlled by standard medical therapy\n* Systemic disease (cardiovascular, renal, hepatic, etc.) which would prevent study treatment\n* Pregnancy or breast feeding. Female of child-bearing potential should conduct contraception during the clinical trial.\n* Patients treated with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days\n* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug\n* Patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the study protocol\n* History of hypersensitivity to any of the study drug or excipients'}, 'identificationModule': {'nctId': 'NCT00452660', 'briefTitle': 'Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'A Phase IV , Multicenter ,Open Label ,Non Comparative ,Investigator Initiated Study , Evaluating the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load', 'orgStudyIdInfo': {'id': 'CICL670A2412-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'evaluating the effect of -Exjade', 'description': 'evaluating the effect of -Exjade (Deferasirox)\\_on oxidative stress parameters of blood cells in patients with Low risk Mylodysplastic syndrome ( MDS) with Iron over load', 'interventionNames': ['Drug: Exjade']}], 'interventions': [{'name': 'Exjade', 'type': 'DRUG', 'armGroupLabels': ['evaluating the effect of -Exjade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Wolfsom Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'overallOfficials': [{'name': 'Rachmilewitz Eliezer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Wolfson Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Soroka University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Hematology Department , E. Wolfson Medical center ,Holon- Israel.', 'investigatorFullName': 'eliezer rachmilewitz', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}