Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-29 @ 5:45 AM
Study NCT ID:
NCT01271868
Status:
TERMINATED
Last Update Posted:
2021-03-15
First Post:
2011-01-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002836', 'term': 'Hemophilia B'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579324', 'term': 'IB1001'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schaafd@apvo.com', 'phone': '206-859-6655', 'title': 'Dr. David Schaaf', 'organization': 'Aptevo Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to a small number of subjects analyzed'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'IB1001', 'description': 'IB1001 Safety population includes all subjects who received at least one dose of IB1001', 'otherNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Infusions Required for Bleed Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Number of Infusions', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'Treatment phase: Prophylaxis treatment (n=8) and on demand treatment (n=1)'}], 'classes': [{'categories': [{'title': '0 infusions', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': '1 infusion', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': '2 infusions', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '3 infusions', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '4 infusions', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '5 infusions', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Treatment Study: at least 50 ED (approximately 6 months); actual mean subject duration: 39.7 ± 12.4 months', 'unitOfMeasure': 'Number of Infusions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Infusions', 'denomUnitsSelected': 'Number of Infusions'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (0-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'PK phase'}], 'classes': [{'categories': [{'measurements': [{'value': '1062', 'spread': '322', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours', 'unitOfMeasure': 'IU*hr/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'PK phase'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.'}, {'type': 'SECONDARY', 'title': 'Concentration (Max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'PK phase'}], 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '15.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours', 'unitOfMeasure': 'IU/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.'}, {'type': 'SECONDARY', 'title': 'Incremental Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'PK phase'}], 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'spread': '0.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours', 'unitOfMeasure': 'IU/dL per IU/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.'}, {'type': 'SECONDARY', 'title': 'Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'PK phase'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours', 'unitOfMeasure': 'mL/(kg*hr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (Steady State)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'PK phase'}], 'classes': [{'categories': [{'measurements': [{'value': '244', 'spread': '166', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours', 'unitOfMeasure': 'mL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '9 subjects completed the PK phase. Only 6 subjects had adequate data for formal PK analysis.'}, {'type': 'SECONDARY', 'title': 'Annualized Bleed Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IB1001', 'description': 'Treatment study for those receiving prophylaxis treatment (n=8)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Treatment Study: at least 50 ED (approximately 6 months); actual mean subject duration: 41.7+/- 11.7 Months', 'description': 'Measure was assessed during the Treatment Study', 'unitOfMeasure': 'bleeds/year', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IB1001'}], 'periods': [{'title': 'Pharmacokinetic Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Treatment Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IB1001', 'description': 'PK study and Treatment Study'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '0 to 5 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '6 to 11 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'years'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'dispFirstSubmitDate': '2019-01-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-11', 'studyFirstSubmitDate': '2011-01-06', 'dispFirstSubmitQcDate': '2019-01-10', 'resultsFirstSubmitDate': '2019-02-28', 'studyFirstSubmitQcDate': '2011-01-06', 'dispFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-20', 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Infusions Required for Bleed Control', 'timeFrame': 'Treatment Study: at least 50 ED (approximately 6 months); actual mean subject duration: 39.7 ± 12.4 months'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve (0-inf)', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours'}, {'measure': 'Terminal Half-life', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours'}, {'measure': 'Concentration (Max)', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours'}, {'measure': 'Incremental Recovery', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours'}, {'measure': 'Clearance', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours'}, {'measure': 'Volume of Distribution (Steady State)', 'timeFrame': 'Pre-infusion to 72 hours following infusion', 'description': 'Factor IX levels were assessed at the following time points:\n\nPre-infusion, post-infusion at 15-30 min, 4-6 hours, 24-26 hours, 68-72 hours'}, {'measure': 'Annualized Bleed Rate', 'timeFrame': 'Treatment Study: at least 50 ED (approximately 6 months); actual mean subject duration: 41.7+/- 11.7 Months', 'description': 'Measure was assessed during the Treatment Study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Recombinant Factor IX'], 'conditions': ['Hemophilia B']}, 'descriptionModule': {'briefSummary': "The Study's Primary Objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of IB1001 in previously treated pediatric subjects with hemophilia B."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject's parent or legal guardian must give written Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent and be willing to make the required study visits and follow instructions while enrolled in the study. For subjects ≥7 years of age, assent will be obtained if required by the institution. For subjects \\< 7 years of age, legal assent is not reasonable to obtain.\n2. Severe (factor IX activity ≤2 IU/dL) hemophilia B subjects currently on-demand therapy with a minimum of 2 bleeding episodes requiring factor IX therapy over the preceding 6 months or 4 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern similar to that above demonstrated prior to starting prophylaxis\n3. Immunocompetent (CD4 count \\>400/mm3) and not receiving immune modulating or chemotherapeutic agents\n4. Previously treated patients with a minimum of 50 exposure days to a factor IX preparation\n5. Platelet count at least 150,000/mm3\n6. Liver function: alanine transaminase \\[ALT\\] and aspartate transaminase \\[AST\\] ≤2 times the upper limit of the normal range\n7. Total bilirubin ≤1.5 times the upper limit of the normal range\n8. Renal function: serum creatinine ≤1.25 times the upper limit of the normal range\n9. Willingness to participate in the trial for approximately 6 months (50 exposures)\n10. Age ≤12 years\n11. Hemoglobin ≥7 g/dL at the time of the blood draw\n\nExclusion Criteria:\n\n1. History of factor IX inhibitor ≥0.6 Bethesda units (BU)\n2. Existence of another coagulation disorder\n3. Evidence of thrombotic disease, fibrinolysis, or disseminated intravascular coagulation (DIC)\n4. Use of an investigational drug within 30 days prior to study entry\n5. On medications that could impact hemostasis, such as aspirin\n6. History of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol\n7. History of adverse reaction to either plasma-derived factor IX or recombinant factor IX that interfered with the subject's ability to treat bleeding episodes with a factor IX product"}, 'identificationModule': {'nctId': 'NCT01271868', 'briefTitle': 'Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medexus Pharma, Inc.'}, 'officialTitle': 'Study of Recombinant Factor IX Product, IB1001, in Previously Treated Pediatric Subjects With Hemophilia B', 'orgStudyIdInfo': {'id': 'IB1001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IB1001', 'interventionNames': ['Biological: IB1001']}], 'interventions': [{'name': 'IB1001', 'type': 'BIOLOGICAL', 'otherNames': ['Recombinant factor IX', 'IXINITY'], 'armGroupLabels': ['IB1001']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'RUSH University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hemophilia & Thrombosis Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Gulf States Hemophilia & Thrombophilia Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '700073', 'city': 'Kolkata', 'country': 'India', 'facility': 'AMRI Hospital, Institute of Haematology & Transfusion Medicine', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '141008', 'city': 'Ludhiana', 'country': 'India', 'facility': 'Christian Medical College and Hospital', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '411001', 'city': 'Pune', 'country': 'India', 'facility': 'Jehangir Clinical Development Centre Pvt. Ltd. Jehangir Hospital Premises', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411004', 'city': 'Pune', 'country': 'India', 'facility': 'Sahyadri Speciality Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '390003', 'city': 'Vadodara', 'country': 'India', 'facility': 'Bhailal Amin General Hospital', 'geoPoint': {'lat': 22.29941, 'lon': 73.20812}}, {'zip': '632004', 'city': 'Vellore', 'country': 'India', 'facility': 'Christian Medical College', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medexus Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}