Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01233258
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2010-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in 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': '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': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'BAYER'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse event data reported here were collected from start of first treatment up to 12.5 months (end of observation period).', 'description': 'Abbreviations used in the Adverse Events section: Medical Dictionary for Regulatory Activities (MedDRA)', 'eventGroups': [{'id': 'EG000', 'title': 'rFVIII (BAY81-8973) Treatment', 'description': 'Participants received on-demand or prophylaxis treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization', 'otherNumAtRisk': 80, 'otherNumAffected': 23, 'seriousNumAtRisk': 80, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'seriousEvents': [{'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annualized Number of All Bleeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFVIII (BAY81-8973) on Demand', 'description': 'Participants received on-demand treatment rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization'}, {'id': 'OG001', 'title': 'rFVIII (BAY81-8973) Prophylaxis Treatment', 'description': 'Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'spread': '24.6', 'groupId': 'OG000', 'lowerLimit': '41.7', 'upperLimit': '76.3'}, {'value': '4.9', 'spread': '6.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.0'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiplicity adjustment as only 1 primary endpoint.', 'groupDescription': 'Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation: Assumption 5 bleeds per year on prophylactic treatment, 15 on on-demand treatment; 2-sided alpha 5% and 90% power.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustment, no transformation of data seemed to be necessary.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)', 'description': 'The annualized number of bleeds experienced by participants', 'unitOfMeasure': 'Bleeds per year per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT (Intent to Treat). Low and high dose prophylaxis arms and both potencies combined as planned for the statistical analysis to achieve intended sample size.'}, {'type': 'SECONDARY', 'title': 'Annualized Number of All Bleeds During CS/EP Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFVIII (BAY81-8973) on Demand Assayed by CS/EP', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months'}, {'id': 'OG001', 'title': 'rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/EP', 'description': 'Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.6', 'spread': '24.3', 'groupId': 'OG000', 'lowerLimit': '39.4', 'upperLimit': '72.7'}, {'value': '5.1', 'spread': '8.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.8'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No multiplicity adjustment as this is not primary endpoint.', 'groupDescription': 'Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustment, no transformation of data seemed to be necessary.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months (6 months on CS/EP potency assignment)', 'description': 'The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/EP', 'unitOfMeasure': 'Bleeds per year per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.'}, {'type': 'SECONDARY', 'title': 'Annualized Number of All Bleeds During CS/ADJ Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months'}, {'id': 'OG001', 'title': 'rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/ADJ', 'description': 'Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '25.1', 'groupId': 'OG000', 'lowerLimit': '41.0', 'upperLimit': '77.8'}, {'value': '4.8', 'spread': '6.8', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '7.8'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: bleeding rates are equal, alternative hypothesis rates are unequal. Power calculation not done for this comparison as not primary comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'No adjustment, no transformation of data seemed to be necessary.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 6 months (6 months on CS/ADJ potency assignment)', 'description': 'The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/ADJ', 'unitOfMeasure': 'Bleeds per year per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Low and high dose prophylaxis arms combined as planned for the statistical analysis to achieve sufficient sample size.'}, {'type': 'SECONDARY', 'title': 'Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'rFVIII (BAY81-8973) on Demand Assayed by CS/EP', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months'}, {'id': 'OG001', 'title': 'rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '77.8', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '65.7', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0001', 'ciLowerLimit': '-0.0490', 'pValueComment': 'No multiplicity adjustment as not primary endpoint.', 'estimateComment': 'Confidence interval calculated with exact Hodges- Lehmann estimates for CS/EP minus CS/ADJ', 'groupDescription': 'Null hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is less than the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. Alternative hypothesis: the proportion of bleeds controlled by no more than 2 infusions in the CS/EP group plus 10% is greater than or equal to the proportion of bleeds controlled by no more than 2 infusions in the CS/ADJ group. No power calculation since this is not the primary comparison.', 'statisticalMethod': 'Exact Permutation Test for paired sample', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority margin 10%'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)', 'description': 'The percentage of bleeds per participant on on-demand treatment that stopped after two or fewer injections', 'unitOfMeasure': 'Percentage of bleeds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Bleeds During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rFVIII (BAY81-8973) on Demand', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.'}, {'id': 'OG001', 'title': 'rFVIII (BAY81-8973) Prophylaxis Low-dose', 'description': 'Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization'}, {'id': 'OG002', 'title': 'rFVIII (BAY81-8973) Prophylaxis High-dose', 'description': 'Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization'}], 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '42.0', 'upperLimit': '77.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'The number of bleeds experienced by each participant', 'unitOfMeasure': 'Bleeds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Inhibitory Antibody Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'rFVIII (BAY81-8973) on Demand', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.'}, {'id': 'OG001', 'title': 'rFVIII (BAY81-8973) Prophylaxis Low-dose', 'description': 'Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.'}, {'id': 'OG002', 'title': 'rFVIII (BAY81-8973) Prophylaxis High-dose', 'description': 'Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.'}], 'classes': [{'title': '3 months after baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '6 months after baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '9 months after baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '12 months after baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3, 6, 9 and 12 months after baseline', 'description': 'A test to ensure that participants have not developed antibodies that will interfere with the action of rFVIII (BAY81-8973)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'On Demand, BAY 81-8973 Potency First EP Then ADJ', 'description': 'Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.'}, {'id': 'FG001', 'title': 'On Demand, BAY 81-8973 Potency First ADJ Then EP', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months.'}, {'id': 'FG002', 'title': 'Low Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ', 'description': 'Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.'}, {'id': 'FG003', 'title': 'Low Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP', 'description': 'Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.'}, {'id': 'FG004', 'title': 'High Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ', 'description': 'Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.'}, {'id': 'FG005', 'title': 'High Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP', 'description': 'Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.'}], 'periods': [{'title': 'First Intervention (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Non-compliance with study medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout (2-3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from specialized hemophilia treatment centers.', 'preAssignmentDetails': '83 participants were randomized, but 3 of these terminated the study before their first injection of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '80', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'rFVIII (BAY81-8973) on Demand', 'description': 'Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.'}, {'id': 'BG001', 'title': 'rFVIII (BAY81-8973) Prophylaxis Low-dose', 'description': 'Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.'}, {'id': 'BG002', 'title': 'rFVIII (BAY81-8973) Prophylaxis High-dose', 'description': 'Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 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participant'}, {'measure': 'Number of Participants With Inhibitory Antibody Formation', 'timeFrame': '3, 6, 9 and 12 months after baseline', 'description': 'A test to ensure that participants have not developed antibodies that will interfere with the action of rFVIII (BAY81-8973)'}], 'primaryOutcomes': [{'measure': 'Annualized Number of All Bleeds', 'timeFrame': 'Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)', 'description': 'The annualized number of bleeds experienced by participants'}], 'secondaryOutcomes': [{'measure': 'Annualized Number of All Bleeds During CS/EP Period', 'timeFrame': 'Up to 6 months (6 months on CS/EP potency assignment)', 'description': 'The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/EP'}, {'measure': 'Annualized Number of All Bleeds During CS/ADJ Period', 'timeFrame': 'Up to 6 months (6 months on CS/ADJ potency assignment)', 'description': 'The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/ADJ'}, {'measure': 'Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973)', 'timeFrame': 'Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)', 'description': 'The percentage of bleeds per participant on on-demand treatment that stopped after two or fewer injections'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Haemophilia treatment', 'rFVIII'], 'conditions': ['Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '27002680', 'type': 'RESULT', 'citation': 'Kitchen S, Katterle Y, Beckmann H, Maas Enriquez M. Chromogenic assay for BAY 81-8973 potency assignment has no impact on clinical outcome or monitoring in patient samples. J Thromb Haemost. 2016 Jun;14(6):1192-9. doi: 10.1111/jth.13322. Epub 2016 May 3.'}, {'pmid': '26931631', 'type': 'RESULT', 'citation': 'Oldenburg J, Windyga J, Hampton K, Lalezari S, Tseneklidou-Stoeter D, Beckmann H, Maas Enriquez M. Safety and efficacy of BAY 81-8973 for surgery in previously treated patients with haemophilia A: results of the LEOPOLD clinical trial programme. Haemophilia. 2016 May;22(3):349-53. doi: 10.1111/hae.12839. Epub 2016 Mar 1.'}, {'pmid': '25546368', 'type': 'DERIVED', 'citation': 'Kavakli K, Yang R, Rusen L, Beckmann H, Tseneklidou-Stoeter D, Maas Enriquez M; LEOPOLD II Study Investigators. Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II). J Thromb Haemost. 2015 Mar;13(3):360-9. doi: 10.1111/jth.12828.'}], 'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}]}, 'descriptionModule': {'briefSummary': 'The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. 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