Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-29 @ 2:32 PM
Study NCT ID:
NCT00396292
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2006-11-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007501', 'term': 'Iron'}, {'id': 'C020748', 'term': 'ferrous sulfate'}, {'id': 'C522335', 'term': 'ferric carboxymaltose'}], 'ancestors': [{'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mtokars@lpicrd.com', 'phone': '610-650-4200', 'title': 'Marc Tokars', 'organization': 'Luitpold Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '9 months', 'eventGroups': [{'id': 'EG000', 'title': 'VIT-45', 'description': 'A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered', 'otherNumAtRisk': 174, 'otherNumAffected': 40, 'seriousNumAtRisk': 174, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42', 'otherNumAtRisk': 178, 'otherNumAffected': 61, 'seriousNumAtRisk': 178, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Peripartum cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Postoperative infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 178, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin", 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-45', 'description': 'A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered'}, {'id': 'OG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42'}], 'classes': [{'categories': [{'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'anytime between baseline and the end of study or time to intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Population defined as subjects who received at least 1 dose of randomized study medication, had at least 1 post-baseline hemoglobin assessment, and had postpartum anemia characterized by an average of the 2 baseline central laboratory hemoglobin being \\<11.0 g/dL'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VIT-45', 'description': 'A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered'}, {'id': 'FG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '178'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '162'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Hospitals and medical clinics', 'preAssignmentDetails': "8 subjects randomized to VIT-45 were discontinued prior to dosing due to subject request (3 subjects), lost to follow-up (2 subjects), 'other reasons' (2 subjects), and physician decision (1 subject). The 1 subject that was randomized to oral iron was lost to follow-up."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VIT-45', 'description': 'A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered'}, {'id': 'BG001', 'title': 'Oral Iron Tablets', 'description': '325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.93', 'spread': '6.36', 'groupId': 'BG000'}, {'value': '26.03', 'spread': '5.95', 'groupId': 'BG001'}, {'value': '26.41', 'spread': '6.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '352', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 361}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2006-11-02', 'resultsFirstSubmitDate': '2013-10-15', 'studyFirstSubmitQcDate': '2006-11-03', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-10-15', 'studyFirstPostDateStruct': {'date': '2006-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of Subjects Who Achieved 'Success' Meaning a ≥ 2.0 Increase in Hemoglobin", 'timeFrame': 'anytime between baseline and the end of study or time to intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anemia', 'postpartum', 'Postpartum anemia'], 'conditions': ['Anemia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Baker JB, Seid MH, Van Wyck DB, Mangione A. Ferric Carboxymaltose, a New IV Iron Agent for Postpartum Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.'}, {'type': 'RESULT', 'citation': 'Baker JB, Seid MH, Van Wyck DB, Dinh Q. Ferric Carboxymaltose, a New IV Iron Agent for Treating Postpartum Women with Iron Deficiency Anemia. Society for the Advancement of Blood Management 6th Annual Meeting 2007.'}, {'pmid': '17666600', 'type': 'DERIVED', 'citation': 'Van Wyck DB, Martens MG, Seid MH, Baker JB, Mangione A. Intravenous ferric carboxymaltose compared with oral iron in the treatment of postpartum anemia: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):267-78. doi: 10.1097/01.AOG.0000275286.03283.18.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.', 'detailedDescription': 'This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female Subjects able to give consent\n* Post partum patients\n* Baseline Hbg\\< /= 10\n* Agree to practice birth control\n* Demonstrate willingness to comply with protocol restrictions\n\nExclusion Criteria:\n\n* Known hypersensitivity reaction to oral or IV iron (VIT-45)\n* Documented history of discontinuing oral iron\n* Significant bleeding\n* History of anemia other that iron deficiency anemia\n* Severe Psychiatric disorders\n* Active severe infection\n* Known Hepatitis B antigen or Hep C viral antibody or active hepatitis\n* Known HIV antibody\n* Received investigational product within 30 days\n* Alcohol abuse\n* Hemochromatosis or other iron storage disorder'}, 'identificationModule': {'nctId': 'NCT00396292', 'briefTitle': 'Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Subjects Who Display Postpartum Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in Subjects Who Display Postpartum Anemia', 'orgStudyIdInfo': {'id': '1VIT03001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIT-45', 'description': 'A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered', 'interventionNames': ['Drug: VIT-45']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral iron tablets', 'description': '325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42', 'interventionNames': ['Drug: Oral iron tablets']}], 'interventions': [{'name': 'Oral iron tablets', 'type': 'DRUG', 'otherNames': ['Ferrous Sulfate'], 'description': '325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42', 'armGroupLabels': ['Oral iron tablets']}, {'name': 'VIT-45', 'type': 'DRUG', 'description': 'A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered', 'armGroupLabels': ['VIT-45']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19403', 'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Luitpold Pharmaceuticals', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}