Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT03407651
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2018-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Lebanon'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hlevy@catbio.com', 'phone': '+1.650.266.6871', 'title': 'Howard Levy, Chief Medical Officer', 'organization': 'Catalyst Biosciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A planned outcome measure (coagulation assessment via MarzAA activity levels) of the protocol was not calculated as as a satisfactory assay could not be developed. Data is not reported for two allowed dose groups in Part 2, MarzAA 90 μg and 120 μg, as no subjects were treated at these dose levels'}}, 'adverseEventsModule': {'timeFrame': 'Members of the study team recorded all reportable events with start dates occurring any time after informed consent was obtained until study completion, or discharge, for non-serious AEs and until 30 days after the last day of study participation for SAEs. The duration of the study was 52 days.', 'description': 'Adverse events and serious adverse events are based on the Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'MarzAA IV 18 μg/kg', 'description': 'IV infusion of 18 ug/kg MarzAA, Part 1 of study', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MarzAA SC 30 μg/kg', 'description': 'SC infusion of MarzAA SC 30 μg/kg, Part 1 of study', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MarzAA 30 ug/kg', 'description': 'SC infusion of MarzAA 30 ug/kg, Part 2 of study', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'MarzAA 60 ug/kg', 'description': 'SC infusion of MarzAA 60 ug/kg, Part 2 of study', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhagic vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bleeding Episode Prevention Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2', 'description': 'MarzAA 30 and 60 µg/kg by subcutaneous route\n\nSingle intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4640', 'spread': '3.08638', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 of final MarzAA dose level - Day 50', 'description': 'Annualized bleed rate (ABR; spontaneous and total) during Part 2 when on final MarzAA dose level versus recorded historical ABR. The analysis of the primary endpoint (annualized bleeding rate ABR for spontaneous and traumatic bleeds) of the final dose of MarzAA each subject was treated was based on the 1-sample test compared to a predefined rate assumed for the on-demand therapy. The latter was assumed to be 12 (or 1 bleed per month), which was the minimum ABR for each subject according to inclusion criterion 2 (defined as the H0), with no maximum value. A higher score indicated a worse outcome. ABR is on a scale of 0 to 365, with a lower score reflective of a lower number of bleeding events in a year.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Breakthrough Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1a, MarzAA IV 18 µg/kg', 'description': 'Single intravenous injection of MarzAA 18 µg/kg'}, {'id': 'OG001', 'title': 'Part 1b, MarzAA SC 30 µg/kg', 'description': 'Single subcutaneous injection of MarzAA 30 µg/kg'}, {'id': 'OG002', 'title': 'Part 2, MarzAA 30 µg/kg', 'description': 'MarzAA 30 µg/kg by subcutaneous injection daily for 50 days'}, {'id': 'OG003', 'title': 'Part 2, MarzAA 60 µg/kg', 'description': 'MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 5 of dose level until occurrence of event', 'description': 'Occurrence of breakthrough bleeds requiring escalation to higher dose level', 'unitOfMeasure': 'number of breakthrough bleeds', 'reportingStatus': 'POSTED', 'populationDescription': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required. Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Clinical Thrombotic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1, MarzAA IV 18 µg/kg', 'description': 'Single intravenous infusion of MarzAA 18 µg/kg'}, {'id': 'OG001', 'title': 'Part 1, MarzAA SC 30 µg/kg', 'description': 'Single subcutaneous infusion of MarzAA 30 µg/kg'}, {'id': 'OG002', 'title': 'Part 2, MarzAA 30 µg/kg', 'description': 'MarzAA 30 µg/kg by subcutaneous injection daily for 50 days'}, {'id': 'OG003', 'title': 'Part 2, MarzAA 60 µg/kg', 'description': 'MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of first dose until date of first occurrence of clinical event, assessed up to treatment Day 50', 'description': 'Occurrence of clinical thrombotic event not attributable to another cause', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required. Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Coagulation Assessment - Prothrombin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1a, MarzAA IV 18 µg/kg', 'description': 'Single intravenous infusion of MarzAA 18 µg/kg'}, {'id': 'OG001', 'title': 'Part 1b, MarzAA SC 30 µg/kg', 'description': 'Single subcutaneous infusion of MarzAA 30 µg/kg'}, {'id': 'OG002', 'title': 'Part 2, MarzAA 30 µg/kg', 'description': 'MarzAA 30 µg/kg by subcutaneous injection daily for 50 days'}, {'id': 'OG003', 'title': 'Part 2, MarzAA 60 µg/kg', 'description': 'MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.70', 'groupId': 'OG000', 'lowerLimit': '-5.30', 'upperLimit': '1.50'}, {'value': '-2.80', 'groupId': 'OG001', 'lowerLimit': '-4.8', 'upperLimit': '-0.3'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-6.5', 'upperLimit': '1.2'}, {'value': '-4.80', 'groupId': 'OG003', 'lowerLimit': '-4.8', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of pre-dose to 24 hours (Part 1a), pre-dose to 48 hours (Part 1b), and pre-dose to Day 50 (Part 2)', 'description': 'Change in coagulation parameter (prothrombin time \\[PT\\]) from pre-dose. Min-max values are reflective of the highest and lowest values for all measured timepoints.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required. Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Coagulation Assessment - Activated Partial Thromboplastin Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1a, MarzAA IV 18 µg/kg', 'description': 'Single intravenous infusion of MarzAA 18 µg/kg'}, {'id': 'OG001', 'title': 'Part 1b, MarzAA SC 30 µg/kg', 'description': 'Single subcutaneous infusion of MarzAA 30 µg/kg'}, {'id': 'OG002', 'title': 'Part 2, MarzAA 30 µg/kg', 'description': 'MarzAA 30 µg/kg by subcutaneous injection daily for 50 days'}, {'id': 'OG003', 'title': 'Part 2, MarzAA 60 µg/kg', 'description': 'MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.60', 'groupId': 'OG000', 'lowerLimit': '-57.4', 'upperLimit': '140.8'}, {'value': '1.30', 'groupId': 'OG001', 'lowerLimit': '-30.65', 'upperLimit': '50.1'}, {'value': '-8.30', 'groupId': 'OG002', 'lowerLimit': '-47.3', 'upperLimit': '30.3'}, {'value': '-15.00', 'groupId': 'OG003', 'lowerLimit': '-20.15', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of pre-dose to 24 hours (Part 1a), 48 hours (Part 1b), to Day 50/end of study (Part 2)', 'description': 'Change in coagulation parameter (activated partial thromboplastin time \\[aPTT\\]) from pre-dose. Min-max values are reflective of the highest and lowest values for all measured timepoints.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required. Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Coagulation Assessment - Fibrinogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1a', 'description': 'MarzAA 18 µg/kg by intravenous injection'}, {'id': 'OG001', 'title': 'Part 1b', 'description': 'MarzAA 30 µg/kg by subcutaneous injection'}, {'id': 'OG002', 'title': 'Part 2, MarzAA 30 µg/kg', 'description': 'MarzAA 30 µg/kg by subcutaneous injection daily for 50 days'}, {'id': 'OG003', 'title': 'Part 2, MarzAA 60 ug/kg', 'description': 'MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.0', 'groupId': 'OG000', 'lowerLimit': '-173', 'upperLimit': '51'}, {'value': '-15.00', 'groupId': 'OG001', 'lowerLimit': '-133', 'upperLimit': '108'}, {'value': '-4.0', 'groupId': 'OG002', 'lowerLimit': '-112', 'upperLimit': '146'}, {'value': '-4.0', 'groupId': 'OG003', 'lowerLimit': '-84.0', 'upperLimit': '116'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of pre-dose to 24 hours (Part 1a), 48 hours (Part 1b), or Day 50 (Part 2).', 'description': 'Change in coagulation parameter (fibrinogen) from pre-dose. Min-max values are reflective of the highest and lowest values for all measured timepoints.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required. Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Number of Events of Antibody Formation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1a', 'description': 'MarzAA 18 µg/kg by intravenous injection'}, {'id': 'OG001', 'title': 'Part 1b', 'description': 'MarzAA 30 µg/kg by subcutaneous injection'}, {'id': 'OG002', 'title': 'Part 2, MarzAA 30 µg/kg', 'description': 'MarzAA 30 µg/kg by subcutaneous injection daily for 50 days'}, {'id': 'OG003', 'title': 'Part 2, MarzAA 60 µg/kg', 'description': 'MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first dose of MarzAA until date of first occurrence of clinical event, assessed up to treatment Day 50', 'description': 'Occurrence of antibody formation resulting in a decreased endogenous level of coagulation Factor VII (FVII) or Factor VII activated (FVIIa)', 'unitOfMeasure': 'number of events of antibody formation', 'reportingStatus': 'POSTED', 'populationDescription': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required. Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Number of Events of an Antibody Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1a', 'description': 'MarzAA 18 µg/kg by intravenous injection'}, {'id': 'OG001', 'title': 'Part 1b', 'description': 'MarzAA 30 µg/kg by subcutaneous injection'}, {'id': 'OG002', 'title': 'Part 2, MarzAA 30 µg/kg', 'description': 'MarzAA 30 µg/kg by subcutaneous injection daily for 50 days'}, {'id': 'OG003', 'title': 'Part 2, MarzAA 60 µg/kg', 'description': 'MarzAA 60 µg/kg by subcutaneous injection daily if dose escalation required, up to Day 50'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of first dose of MarzAA until date of first occurrence of clinical event, assessed up to treatment Day 50.', 'description': 'Occurrence of an antibody response to MarzAA and whether it is inhibitory and cross-reactive to wild-type recombinant coagulation FVII (wt-rFVII) or wt-FVIIa.', 'unitOfMeasure': 'number of events of antibody response', 'reportingStatus': 'POSTED', 'populationDescription': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required. Overall number of participants analyzed was based on the Intent-to-Treat Population.'}, {'type': 'SECONDARY', 'title': 'Thrombogenicity Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1a, MarzAA IV 18 µg/kg', 'description': 'MarzAA 18 ug/kg by intravenous injection'}, {'id': 'OG001', 'title': 'Part 1b, MarzAA SC 30 µg/kg', 'description': 'MarzAA 30 ug/kg by subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of pre-dose of MarzAA at Day 1 until date of first occurrence of thrombotic event, assessed up to treatment Day 50.', 'description': 'Number of participants with clinically significant levels of thrombogenicity markers (D-dimer, Prothrombin fragment 1+2 (F1+2), and thrombin-antithrombin complex \\[TAT\\]), based on standard laboratory tests and clinical examination with a specific search for any signs of thrombosis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed was based on the Intent-to-Treat Population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study Population', 'description': 'Period 1: Part 1a\n\nCoagulation Factor VIIa variant, 18 µg/kg by intravenous route\n\nCoagulation Factor VIIa variant: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.\n\nPeriod 2: Part 1b\n\nCoagulation Factor VIIa variant, 30 µg/kg by subcutaneous route\n\nCoagulation Factor VIIa variant: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.\n\nPeriod 3: Part 2\n\nCoagulation Factor VIIa variant, 30, 60, 90, 120 µg/kg by subcutaneous route\n\nCoagulation Factor VIIa variant: Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.'}], 'periods': [{'title': 'Period 1: Part 1a', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Period 2: Part 1b', 'milestones': [{'type': 'STARTED', 'comment': 'One subject completed Part 1a of the study and opted to enter into Part 2 of the study and did not enter Part 1b, making the number of subjects in Part 1b smaller than the number of subjects in Part 1a. That subject withdrew consent after 1 SC dose in Part 2 but is counted as a discontinuation in Part 1 as no additional assessments were performed and the subject did not enter Part 1b. One subject had poor IV access and skipped Part 1b of the study.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Period 3: Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The subject who discontinued after 44 daily SC doses in Part 2 elected to participate in Period 3.', 'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'A total of 11 subjects participated in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Safety Population', 'description': 'Safety Population'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.0', 'spread': '9.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', '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': '11', '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'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '171.57', 'spread': '11.061', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This assessment was not available for one subject in the study.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Population'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.05', 'spread': '21.255', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This assessment was not available for one subject in the study.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Population'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.091', 'spread': '5.1478', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'This assessment was not available for one subject in the study.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Safety Population'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-25', 'size': 4535424, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-25T11:22', 'hasProtocol': True}, {'date': '2018-11-05', 'size': 4442480, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-25T22:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2019-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-21', 'studyFirstSubmitDate': '2018-01-04', 'resultsFirstSubmitDate': '2021-06-25', 'studyFirstSubmitQcDate': '2018-01-16', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-21', 'studyFirstPostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding Episode Prevention Success', 'timeFrame': 'Day 1 of final MarzAA dose level - Day 50', 'description': 'Annualized bleed rate (ABR; spontaneous and total) during Part 2 when on final MarzAA dose level versus recorded historical ABR. The analysis of the primary endpoint (annualized bleeding rate ABR for spontaneous and traumatic bleeds) of the final dose of MarzAA each subject was treated was based on the 1-sample test compared to a predefined rate assumed for the on-demand therapy. The latter was assumed to be 12 (or 1 bleed per month), which was the minimum ABR for each subject according to inclusion criterion 2 (defined as the H0), with no maximum value. A higher score indicated a worse outcome. ABR is on a scale of 0 to 365, with a lower score reflective of a lower number of bleeding events in a year.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Breakthrough Bleeding', 'timeFrame': 'From Day 5 of dose level until occurrence of event', 'description': 'Occurrence of breakthrough bleeds requiring escalation to higher dose level'}, {'measure': 'Occurrence of Clinical Thrombotic Event', 'timeFrame': 'From date of first dose until date of first occurrence of clinical event, assessed up to treatment Day 50', 'description': 'Occurrence of clinical thrombotic event not attributable to another cause'}, {'measure': 'Coagulation Assessment - Prothrombin Time', 'timeFrame': 'From date of pre-dose to 24 hours (Part 1a), pre-dose to 48 hours (Part 1b), and pre-dose to Day 50 (Part 2)', 'description': 'Change in coagulation parameter (prothrombin time \\[PT\\]) from pre-dose. Min-max values are reflective of the highest and lowest values for all measured timepoints.'}, {'measure': 'Coagulation Assessment - Activated Partial Thromboplastin Time', 'timeFrame': 'From date of pre-dose to 24 hours (Part 1a), 48 hours (Part 1b), to Day 50/end of study (Part 2)', 'description': 'Change in coagulation parameter (activated partial thromboplastin time \\[aPTT\\]) from pre-dose. Min-max values are reflective of the highest and lowest values for all measured timepoints.'}, {'measure': 'Coagulation Assessment - Fibrinogen', 'timeFrame': 'From date of pre-dose to 24 hours (Part 1a), 48 hours (Part 1b), or Day 50 (Part 2).', 'description': 'Change in coagulation parameter (fibrinogen) from pre-dose. Min-max values are reflective of the highest and lowest values for all measured timepoints.'}, {'measure': 'Number of Events of Antibody Formation', 'timeFrame': 'From time of first dose of MarzAA until date of first occurrence of clinical event, assessed up to treatment Day 50', 'description': 'Occurrence of antibody formation resulting in a decreased endogenous level of coagulation Factor VII (FVII) or Factor VII activated (FVIIa)'}, {'measure': 'Number of Events of an Antibody Response', 'timeFrame': 'From time of first dose of MarzAA until date of first occurrence of clinical event, assessed up to treatment Day 50.', 'description': 'Occurrence of an antibody response to MarzAA and whether it is inhibitory and cross-reactive to wild-type recombinant coagulation FVII (wt-rFVII) or wt-FVIIa.'}, {'measure': 'Thrombogenicity Assessment', 'timeFrame': 'From time of pre-dose of MarzAA at Day 1 until date of first occurrence of thrombotic event, assessed up to treatment Day 50.', 'description': 'Number of participants with clinically significant levels of thrombogenicity markers (D-dimer, Prothrombin fragment 1+2 (F1+2), and thrombin-antithrombin complex \\[TAT\\]), based on standard laboratory tests and clinical examination with a specific search for any signs of thrombosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemophilia A With Inhibitor', 'Hemophilia B With Inhibitor']}, 'descriptionModule': {'briefSummary': 'Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous \\[SC\\] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of frequent spontaneous bleeding episodes.', 'detailedDescription': "Multi-center, open-label Phase 2 study to evaluate the PK, bioavailability, PD, efficacy and safety of a daily SC treatment regimen with MarzAA for bleeding prophylaxis in adult subjects with hemophilia A or B with an inhibitor. The study will enroll and dose, both intravenously and subcutaneously, a total of 12 adult male subjects with severe congenital hemophilia A or B with an inhibitor, and history of frequent bleeding episodes during the 6 months prior to enrollment, as per the individual's bleeding and treatment records.\n\nOnce a subject is enrolled into the trial, the study will be conducted in three parts (occurring consecutively):\n\nPart 1a (24 hours): Single IV administration of MarzAA; Part 1b (48 hours): Single SC administration of MarzAA; Part 2: Daily SC administration. Dose escalation in Part 2 will occur if breakthrough bleeding occurs. Subjects are treated for 50 days at the final dose level required."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe congenital hemophilia A or B with an inhibitor.\n* History of frequent spontaneous bleeding episodes.\n* Male, age 18 or older.\n* Affirmation of informed consent with signature confirmation before any trial-related activities.\n\nExclusion Criteria:\n\n* Receiving prophylaxis treatment.\n* Previous participation in a clinical trial evaluating a modified rFVIIa agent.\n* Known positive antibody to FVII or FVIIa detected by central laboratory at screening.\n* Have a coagulation disorder other than hemophilia A or B.\n* Significant contraindication to participation.'}, 'identificationModule': {'nctId': 'NCT03407651', 'briefTitle': 'Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Catalyst Biosciences'}, 'officialTitle': 'Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of a Daily Subcutaneous Treatment Regimen With Marzeptacog Alfa (Activated) for Bleeding Prophylaxis in Adult Subjects With Hemophilia A and B Subjects With an Inhibitor', 'orgStudyIdInfo': {'id': 'MAA-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1a', 'description': 'Coagulation Factor VIIa variant, 18 µg/kg by intravenous route', 'interventionNames': ['Biological: Coagulation Factor VIIa variant']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1b', 'description': 'Coagulation Factor VIIa variant, 30 µg/kg by subcutaneous route', 'interventionNames': ['Biological: Coagulation Factor VIIa variant']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Coagulation Factor VIIa variant, 30, 60, 90, 120 µg/kg by subcutaneous route', 'interventionNames': ['Biological: Coagulation Factor VIIa variant']}], 'interventions': [{'name': 'Coagulation Factor VIIa variant', 'type': 'BIOLOGICAL', 'description': 'Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.', 'armGroupLabels': ['Part 1a', 'Part 1b', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yerevan', 'country': 'Armenia', 'facility': 'Hematology Center after Prof. R. Yeolyan', 'geoPoint': {'lat': 40.17765, 'lon': 44.5126}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'JSC "K.Eristavi National Center of Experimental and Clinical Surgery"', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD M.Zodelava Hematology Centre', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Tbilisi', 'country': 'Georgia', 'facility': 'LTD Medinvest - Institute of Hematology and Transfusiology', 'geoPoint': {'lat': 41.69143, 'lon': 44.83412}}, {'city': 'Rzeszów', 'country': 'Poland', 'facility': 'Gabinet Lekarski, Bartosz Korczowski', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Regional Clinical Hospital', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Kirov', 'country': 'Russia', 'facility': 'FGU Kirov Scientific Research', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Center for Hemophilia Treatment', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Haemophilia Comprehensive Care Centre', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Howard Levy, MD, PhD, MMM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Catalyst Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This is an open label study so each investigator will have full access to all study subject data that is entered into the database'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catalyst Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}