Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-29 @ 1:19 PM
Study NCT ID:
NCT00916032
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2009-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C078147', 'term': 'F8 protein, human'}, {'id': 'D005169', 'term': 'Factor VIII'}], 'ancestors': [{'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': "Baxter's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication of the main/primary endpoint or ≤24 months after study completion. Baxter requires a review of results communications (e.g., for confidential information) prior to submission for publication, and shall review and if necessary amend the manuscript in ≤30 days", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout the study period, approximately 10 months', 'eventGroups': [{'id': 'EG000', 'title': 'One 3000 International Unit (IU) Vial', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Two 1500 IU Vials', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1158', 'spread': '335', 'groupId': 'OG000'}, {'value': '1264', 'spread': '364', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'paired t-test done on the Log(AUC 0-48h)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed using the linear trapezoidal method.', 'unitOfMeasure': '(IU·h)/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1129', 'spread': '310', 'groupId': 'OG000'}, {'value': '1226', 'spread': '358', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.162', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'paired t-test done on the Log(AUC 0-48h)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed using the linear trapezoidal method.', 'unitOfMeasure': '(IU·h)/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1267', 'spread': '395', 'groupId': 'OG000'}, {'value': '1383', 'spread': '437', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.', 'unitOfMeasure': '(IU·h)/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1235', 'spread': '364', 'groupId': 'OG000'}, {'value': '1348', 'spread': '427', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.', 'unitOfMeasure': '(IU·h)/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Incremental Recovery at Cmax - Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.81', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '2.04', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.', 'description': 'Determined as the highest Factor VIII (FVIII) activity achieved post-infusion', 'unitOfMeasure': '(IU/dL)/(IU/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Incremental Recovery at Cmax - One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.75', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.', 'description': 'Determined as the highest FVIII activity achieved post-infusion', 'unitOfMeasure': '(IU/dL)/(IU/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Incremental Recovery at 30 Minutes- Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.62', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.84', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes pre-infusion and 30 minutes post-infusion', 'description': 'Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion', 'unitOfMeasure': '(IU/dL)/(IU/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Incremental Recovery at 30 Minutes- One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.64', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30 minutes pre-infusion and 30 minutes post-infusion', 'description': 'Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion', 'unitOfMeasure': '(IU/dL)/(IU/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Elimination Phase Half-life- Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.27', 'spread': '4.05', 'groupId': 'OG000'}, {'value': '12.84', 'spread': '4.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'calculated as log\\_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Elimination Phase Half-life- One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.80', 'spread': '3.95', 'groupId': 'OG000'}, {'value': '13.50', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'calculated as log\\_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'FVIII Clearance- Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.57', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '1.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'computed as the dose divided by total AUC', 'unitOfMeasure': 'mL/(kg·h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'FVIII Clearance- One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.66', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '4.06', 'spread': '1.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed as the dose divided by total AUC', 'unitOfMeasure': 'mL/(kg·h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Mean Residence Time (MRT)- Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '17.02', 'spread': '5.37', 'groupId': 'OG000'}, {'value': '16.84', 'spread': '5.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Mean Residence Time (MRT)- One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '16.95', 'spread': '4.77', 'groupId': 'OG000'}, {'value': '17.16', 'spread': '4.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State- Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.72', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.61', 'spread': '0.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'computed as Clearance (CL) \\* Mean residence time (MRT)', 'unitOfMeasure': 'dL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State- One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'computed as CL \\* MRT', 'unitOfMeasure': 'dL/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '94', 'spread': '21', 'groupId': 'OG000'}, {'value': '101', 'spread': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Determined as the highest FVIII activity achieved post-infusion.', 'unitOfMeasure': 'IU/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'One 3000 International Unit (IU) Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent'}, {'id': 'OG001', 'title': 'Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'spread': '21', 'groupId': 'OG000'}, {'value': '98', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Determined as the highest FVIII activity achieved post-infusion.', 'unitOfMeasure': 'IU/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Two 1500 IU Vials Then One 3000 IU Vial', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by one 3000 IU potency vial dissolved in 5 mL diluent.'}, {'id': 'FG001', 'title': 'One 3000 IU Vial Then Two 1500 IU Vials', 'description': 'Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment was conducted in Russia and Bulgaria at 4 clinical sites.', 'preAssignmentDetails': '29 participants were enrolled. Six participants discontinued, (four were screen failures and two were withdrawn before randomization). Therefore 23 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants', 'description': 'Participants were randomized to receive via intravenous infusion 3000 International Units (IU) Advate using either one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-28', 'studyFirstSubmitDate': '2009-06-05', 'resultsFirstSubmitDate': '2013-03-31', 'studyFirstSubmitQcDate': '2009-06-05', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-03', 'studyFirstPostDateStruct': {'date': '2009-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed using the linear trapezoidal method.'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From 0 to 48 Hours (AUC 0-48h). One-stage Activated Partial Thromboplastin Time (aPTT) Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed using the linear trapezoidal method.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.'}, {'measure': 'Area Under the Plasma Concentration Versus Time Curve From 0 to Infinity (AUC 0-infinity). One-stage aPTT Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'The total area under the plasma concentration versus time curve when the concentration is extrapolated to zero using the slope of the β-phase of the model.'}, {'measure': 'Incremental Recovery at Cmax - Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.', 'description': 'Determined as the highest Factor VIII (FVIII) activity achieved post-infusion'}, {'measure': 'Incremental Recovery at Cmax - One-stage aPTT Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3 hours.', 'description': 'Determined as the highest FVIII activity achieved post-infusion'}, {'measure': 'Incremental Recovery at 30 Minutes- Chromogenic Assay', 'timeFrame': '30 minutes pre-infusion and 30 minutes post-infusion', 'description': 'Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion'}, {'measure': 'Incremental Recovery at 30 Minutes- One-stage aPTT Assay', 'timeFrame': '30 minutes pre-infusion and 30 minutes post-infusion', 'description': 'Change in factor VIII concentration from pre-infusion to 30 minutes post-infusion'}, {'measure': 'Elimination Phase Half-life- Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'calculated as log\\_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model'}, {'measure': 'Elimination Phase Half-life- One-stage aPTT Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'calculated as log\\_e2/λ, where λ is the regression slope in the terminal phase of the least absolute deviations regression model'}, {'measure': 'FVIII Clearance- Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'computed as the dose divided by total AUC'}, {'measure': 'FVIII Clearance- One-stage aPTT Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed as the dose divided by total AUC'}, {'measure': 'Mean Residence Time (MRT)- Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)'}, {'measure': 'Mean Residence Time (MRT)- One-stage aPTT Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Computed as total area under the first moment curve (Total AUMC) divided by the total area under the concentration versus time curve (Total AUC)'}, {'measure': 'Volume of Distribution at Steady State- Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'computed as Clearance (CL) \\* Mean residence time (MRT)'}, {'measure': 'Volume of Distribution at Steady State- One-stage aPTT Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'computed as CL \\* MRT'}, {'measure': 'Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- Chromogenic Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Determined as the highest FVIII activity achieved post-infusion.'}, {'measure': 'Factor VIII (FVIII) Maximum Plasma Concentration (C-max)- One-stage aPTT Assay', 'timeFrame': 'Within 30 minutes prior to the start of the infusion; and after the end of the infusion at 15, 30 minutes, and 1, 3, 6, 9, 24, 28, 32, and 48 hours.', 'description': 'Determined as the highest FVIII activity achieved post-infusion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemophilia A']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to compare the pharmacokinetic parameters of 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent with that of 3000 IU Advate using two vials of 1500 IU potency dissolved in 5 mL diluent each (administered in 10 mL diluent in total) in previously treated patients with severe hemophilia A (factor VIII level \\< 1%).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant is 18 to 65 years old, at the time of screening\n* Participant has provided signed informed consent\n* Participant has severe hemophilia A, defined by a baseline FVIII level \\< 1% of normal, as tested at screening at the central laboratory\n* Participant's weight is between 55-65 kg\n* Participant was previously treated with FVIII concentrate(s) for a minimum of 150 exposure days prior to study entry\n* If Participant is HIV positive, he must be immunocompetent as determined with a CD4 count ≥ 200 cells/mm³ (CD4 count at screening)\n* Participant is willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Participant has a detectable FVIII inhibitor at screening, with a titer ≥ 0.4 Bethesda unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the central laboratory\n* Participant has a history of FVIII inhibitors with a titer ≥ 0.4 BU (by Nijmegen assay) or ≥ 0.5 BU (by Bethesda Assay) at any time prior to screening\n* Participant has undergone a surgery within 21 days prior to screening or within 6 weeks prior to the anticipated first pharmacokinetics(PK) infusion\n* Participant has an abnormal renal function (serum creatinine \\> 1.5 mg/dL)\n* Participant has active hepatic disease (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\>5 times the upper limit of normal)\n* Participant has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \\> 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly, and history of esophageal varices\n* Participant has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (eg, late-stage chronic liver disease, immune thrombocytopenia purpura)\n* Participant is currently receiving, or is scheduled to receive during the course of the clinical study, an immunomodulating drug other than anti-retroviral chemotherapy (eg, alfa-interferon, or corticosteroid agents at a dose equivalent to hydrocortisone greater than 10 mg/day)\n* Participant has a known hypersensitivity to mouse or hamster proteins\n* Participant has participated in another clinical study involving an investigational product or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this clinical study\n* Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures\n* Participant is a member of the team conducting this clinical study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, or parents) as well as employees of the investigator or site personnel conducting the clinical study."}, 'identificationModule': {'nctId': 'NCT00916032', 'briefTitle': 'Pharmacokinetic Study of ADVATE 3000 IU in Previously Treated Patients With Severe Hemophilia A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Pharmacokinetic Comparison of 3000 IU Advate (rAHF-PFM) (Using One 3000 IU Potency Vial) With 3000 IU Advate (rAHF PFM) (Using Two 1500 IU Potency Vials) in Previously Treated Patients With Severe Hemophilia A: a Phase 4, Open-label, Prospective, Randomized, Controlled, Crossover, Multiple Center Study', 'orgStudyIdInfo': {'id': '060801'}, 'secondaryIdInfos': [{'id': '2008-007347-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'One infusion using a 3000 IU potency vial of Advate dissolved and administered in 5 mL diluent followed by a second infusion of two 1500 IU potency vials of Advate dissolved in 5 mL diluent each (administered in 10 mL diluent in total)', 'interventionNames': ['Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'One infusion of two 1500 IU potency vials of Advate dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by a second infusion of one 3000 IU potency vial of Advate dissolved and administered in 5 mL diluent', 'interventionNames': ['Biological: Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]']}], 'interventions': [{'name': 'Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]', 'type': 'BIOLOGICAL', 'otherNames': ['ADVATE', 'Antihemophilic Factor (Recombinant)- Plasma/albumin free method (rAHF-PFM)'], 'description': 'Participants will receive 3000 IU Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1233', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'city': 'Kirov', 'country': 'Russia', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'zip': '125167', 'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '195213', 'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}