Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT00548860
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2007-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
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': 'C522335', 'term': 'ferric carboxymaltose'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfalone@luitpold.com', 'phone': '610-650-4200', 'title': 'Mark Falone, MD', 'organization': 'Luitpold Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year and 5 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': 'Intravenous (IV) iron', 'otherNumAtRisk': 996, 'otherNumAffected': 9, 'seriousNumAtRisk': 996, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Standard Medical Care (SMC)', 'description': 'SMC for postpartum and heavy uterine bleeding subjects with anemia', 'otherNumAtRisk': 1022, 'otherNumAffected': 79, 'seriousNumAtRisk': 1022, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal adhesions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Necrotising Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Postoperative abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Endometritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Postpartum hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Retained placenta or membranes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Uterine hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 6}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 996, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1022, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'OG000'}, {'value': '1022', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': 'Intravenous (IV) iron'}, {'id': 'OG001', 'title': 'Standard Medical Care (SMC)', 'description': 'SMC for postpartum and heavy uterine bleeding subjects with anemia'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 0 through 30 days after the last dose of study drug.', 'description': "Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': 'Intravenous (IV) iron'}, {'id': 'FG001', 'title': 'Standard Medical Care (SMC)', 'description': 'SMC for postpartum and heavy uterine bleeding subjects with anemia'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '996'}, {'groupId': 'FG001', 'numSubjects': '1022'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '860'}, {'groupId': 'FG001', 'numSubjects': '847'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '175'}]}]}], 'recruitmentDetails': 'Hospitals and medical clinics'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '996', 'groupId': 'BG000'}, {'value': '1022', 'groupId': 'BG001'}, {'value': '2018', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': 'Intravenous (IV) iron'}, {'id': 'BG001', 'title': 'Standard Medical Care (SMC)', 'description': 'SMC for postpartum and heavy uterine bleeding subjects with anemia'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '971', 'groupId': 'BG000'}, {'value': '995', 'groupId': 'BG001'}, {'value': '1966', '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': '31.2', 'spread': '9.36', 'groupId': 'BG000'}, {'value': '31.4', 'spread': '8.98', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '9.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '996', 'groupId': 'BG000'}, {'value': '1022', 'groupId': 'BG001'}, {'value': '2018', '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': '996', 'groupId': 'BG000'}, {'value': '1022', 'groupId': 'BG001'}, {'value': '2018', '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': 2018}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2007-10-22', 'resultsFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-11', 'studyFirstPostDateStruct': {'date': '2007-10-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the Safety of the Maximum Administered Dose, 15 mg/kg (up to a Maximum 1,000 mg) of FCM Compared to SMC.', 'timeFrame': 'From Day 0 through 30 days after the last dose of study drug.', 'description': "Evaluate the safety of the maximum administered dose, 15 mg/kg (up to a maximum 1,000 mg) of FCM compared to SMC. The primary safety endpoint was the incidence of Serious Adverse Events (SAE's)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anemia']}, 'referencesModule': {'references': [{'pmid': '28487769', 'type': 'DERIVED', 'citation': 'Seid MH, Butcher AD, Chatwani A. Ferric Carboxymaltose as Treatment in Women with Iron-Deficiency Anemia. Anemia. 2017;2017:9642027. doi: 10.1155/2017/9642027. Epub 2017 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female with iron deficiency anemia\n* Hg \\</= 11 g/dL\n\nExclusion Criteria:\n\n* Previous participation in a FCM trial\n* Known Hypersensitivity to FCM\n* History of anemia other that anemia due to heavy uterine bleeding or the post partum state\n* current history of GI bleeding\n* Received IV Iron within the month prior\n* Anticipated need for surgery\n* Malignancy history\n* AST or ALT greater than normal\n* Received an investigational drug within 30 days of screening\n* Pregnant or sexually active females who are not willing ot use an effective form of birth control'}, 'identificationModule': {'nctId': 'NCT00548860', 'briefTitle': 'Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'A Multi-center, Randomized Controlled Study to Investigate the Safety and Tolerability of IV Ferric Carboxymaltose (FCM) vs Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients', 'orgStudyIdInfo': {'id': '1VIT07017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferric Carboxymaltose (FCM)', 'description': 'Undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg)', 'interventionNames': ['Drug: Ferric Carboxymaltose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Medical Care (SMC)', 'description': 'Varied as determined by the Investigator', 'interventionNames': ['Drug: Standard Medical Care (SMC)']}], 'interventions': [{'name': 'Ferric Carboxymaltose', 'type': 'DRUG', 'armGroupLabels': ['Ferric Carboxymaltose (FCM)']}, {'name': 'Standard Medical Care (SMC)', 'type': 'DRUG', 'armGroupLabels': ['Standard Medical Care (SMC)']}]}, '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'}}}}