Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-28 @ 4:42 AM
Study NCT ID:
NCT01912456
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2013-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056829', 'term': 'Hereditary Angioedema Types I and II'}, {'id': 'D054179', 'term': 'Angioedemas, Hereditary'}], 'ancestors': [{'id': 'D000799', 'term': 'Angioedema'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000081208', 'term': 'Hereditary Complement Deficiency Diseases'}, {'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': '610-878-4000', 'title': 'Study Director', 'organization': 'CSL Behring GmbH'}, 'certainAgreement': {'otherDetails': 'CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'During the treatment phase, up to 32 weeks.', 'description': 'The Safety Population consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product', 'eventGroups': [{'id': 'EG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 10, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 17, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo High', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 12, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo Low', 'description': 'Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 12, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 86, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 20, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 36, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 28, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 90, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 34, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 39, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 18, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 62, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Hereditary angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Time-normalized Number of Hereditary Angioedema Attacks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo High', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}, {'id': 'OG003', 'title': 'Placebo Low', 'description': 'Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.009', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.011', 'groupId': 'OG002'}, {'value': '0.13', 'spread': '0.009', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.114', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During the treatment phase, up to 28 weeks.', 'description': 'The time normalized number of HAE attacks as reported by the investigator per subject was calculated as: The total number of HAE attacks per subject and per treatment period / length of stay of subject in treatment period (days), Where length of stay of subject in treatment period was calculated as: Date of last day of subject in treatment period - date of first day of Week 3 of subject in treatment period + 1.', 'unitOfMeasure': 'attacks/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat (ITT) population consisted of all subjects who provided informed consent / assent and were randomized, regardless of whether they received investigational product.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With a ≥ 50% Reduction in the Number of Hereditary Angioedema Attacks by CSL830 Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '86.5'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '76.9', 'upperLimit': '96.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'difference in percentages of responder', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '29.7', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'During the treatment phase, up to 28 weeks.', 'description': 'The percentage reduction (%) in the time normalized number of HAE attacks was calculated as: 100 x \\[1 - (the time normalized number of HAE attacks when treated with CSL830) / (the time normalized number of HAE attacks when treated with placebo)\\]. A subject is classed as a responder if the percentage reduction is \\>= 50%.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Subjects whose time-normalized number of attacks could not be calculated in one or both CSL830 treatment periods were excluded from the analysis. Percentages are based on the number of subjects included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time-Normalized Number of Uses of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo High', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}, {'id': 'OG003', 'title': 'Placebo Low', 'description': 'Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'spread': '0.042', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.011', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.04', 'groupId': 'OG002'}, {'value': '0.13', 'spread': '0.011', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.018', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '= 0.31', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'During the treatment phase, up to 28 weeks.', 'description': 'The time-normalized number of uses of rescue medication during treatment with C1-esterase inhibitor or placebo', 'unitOfMeasure': 'rescue medication uses/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Adverse Events (AEs) Within 24 Hours of C1-esterase Inhibitor or Placebo Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo High', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}, {'id': 'OG003', 'title': 'Placebo Low', 'description': 'Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '60.5', 'groupId': 'OG001'}, {'value': '45.5', 'groupId': 'OG002'}, {'value': '54.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours of C1-esterase inhibitor or placebo administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population (SP) consisted of all subjects who provided informed consent / assent, were randomized, and received at least 1 dose (or partial dose) of investigational product.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With AEs or Other Specified Safety Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo High', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}, {'id': 'OG003', 'title': 'Placebo Low', 'description': 'Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}, {'value': '61.4', 'groupId': 'OG002'}, {'value': '71.4', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the treatment phase, up to 32 weeks.', 'description': 'The percentage of subjects experiencing the following during treatment with CSL830 and placebo: unsolicited AEs, serious AEs, suspected adverse drug reactions, increased risk scores for deep vein thrombosis and pulmonary embolism, thromboembolic events, inhibitory anti C1 INH antibodies, or clinically significant abnormalities in laboratory assessments.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SP'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Experiencing Solicited AEs (Injection Site Reactions)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo High', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}, {'id': 'OG003', 'title': 'Placebo Low', 'description': 'Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000'}, {'value': '34.9', 'groupId': 'OG001'}, {'value': '22.7', 'groupId': 'OG002'}, {'value': '26.2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the treatment phase, up to 32 weeks.', 'description': 'The percentage of subjects experiencing solicited local AEs (discomfort \\[eg, pain, burning\\], swelling, bruising, or itching at the investigational product injection site) during treatment with CSL830 and placebo.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SP'}, {'type': 'SECONDARY', 'title': 'Injections Resulting in Solicited AEs (Injection Site Reactions)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}, {'units': 'number of injections within treatment', 'counts': [{'value': '1307', 'groupId': 'OG000'}, {'value': '1320', 'groupId': 'OG001'}, {'value': '1290', 'groupId': 'OG002'}, {'value': '1164', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL830 (40)', 'description': 'Low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG001', 'title': 'CSL830 (60)', 'description': 'High-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'OG002', 'title': 'Placebo High', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}, {'id': 'OG003', 'title': 'Placebo Low', 'description': 'Low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000'}, {'value': '0.08', 'groupId': 'OG001'}, {'value': '0.12', 'groupId': 'OG002'}, {'value': '0.05', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the treatment phase, up to 32 weeks.', 'description': 'The rate/injection of injections of C1-esterase inhibitor or placebo that were followed by solicited local AEs (discomfort \\[eg, pain, burning\\], swelling, bruising, or itching at the investigational product injection site) during treatment with CSL830 and placebo. Rate/Injection = Number of events/number of injections.', 'unitOfMeasure': 'injection site reactions/injection', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'number of injections within treatment', 'denomUnitsSelected': 'number of injections within treatment', 'populationDescription': 'SP'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo High/CSL830 (40)', 'description': 'High-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'FG001', 'title': 'CSL830 (40)/Placebo High', 'description': 'A low-volume dose of C1-esterase inhibitor (CSL830, 40 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a high-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'FG002', 'title': 'Placebo Low/CSL830 (60)', 'description': 'A low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks then a high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks.'}, {'id': 'FG003', 'title': 'CSL830 (60)/Placebo Low', 'description': 'A high-volume dose of C1-esterase inhibitor (CSL830, 60 IU/kg) administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of placebo administered subcutaneously twice a week for up to 16 weeks.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CSL830 (40)/Placebo High'}, {'id': 'BG001', 'title': 'CSL830 (60)/Placebo Low'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.4', 'spread': '14.41', 'groupId': 'BG000'}, {'value': '36.8', 'spread': '14.921', 'groupId': 'BG001'}, {'value': '39.6', 'spread': '14.85', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2016-10-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2013-07-29', 'dispFirstSubmitQcDate': '2016-10-12', 'resultsFirstSubmitDate': '2020-12-11', 'studyFirstSubmitQcDate': '2013-07-29', 'dispFirstPostDateStruct': {'date': '2016-10-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-11', 'studyFirstPostDateStruct': {'date': '2013-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Time-normalized Number of Hereditary Angioedema Attacks', 'timeFrame': 'During the treatment phase, up to 28 weeks.', 'description': 'The time normalized number of HAE attacks as reported by the investigator per subject was calculated as: The total number of HAE attacks per subject and per treatment period / length of stay of subject in treatment period (days), Where length of stay of subject in treatment period was calculated as: Date of last day of subject in treatment period - date of first day of Week 3 of subject in treatment period + 1.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With a ≥ 50% Reduction in the Number of Hereditary Angioedema Attacks by CSL830 Treatment', 'timeFrame': 'During the treatment phase, up to 28 weeks.', 'description': 'The percentage reduction (%) in the time normalized number of HAE attacks was calculated as: 100 x \\[1 - (the time normalized number of HAE attacks when treated with CSL830) / (the time normalized number of HAE attacks when treated with placebo)\\]. A subject is classed as a responder if the percentage reduction is \\>= 50%.'}, {'measure': 'Time-Normalized Number of Uses of Rescue Medication', 'timeFrame': 'During the treatment phase, up to 28 weeks.', 'description': 'The time-normalized number of uses of rescue medication during treatment with C1-esterase inhibitor or placebo'}, {'measure': 'Percentage of Subjects With Adverse Events (AEs) Within 24 Hours of C1-esterase Inhibitor or Placebo Administration', 'timeFrame': 'Within 24 hours of C1-esterase inhibitor or placebo administration.'}, {'measure': 'Percentage of Subjects With AEs or Other Specified Safety Events.', 'timeFrame': 'During the treatment phase, up to 32 weeks.', 'description': 'The percentage of subjects experiencing the following during treatment with CSL830 and placebo: unsolicited AEs, serious AEs, suspected adverse drug reactions, increased risk scores for deep vein thrombosis and pulmonary embolism, thromboembolic events, inhibitory anti C1 INH antibodies, or clinically significant abnormalities in laboratory assessments.'}, {'measure': 'Percentage of Subjects Experiencing Solicited AEs (Injection Site Reactions)', 'timeFrame': 'During the treatment phase, up to 32 weeks.', 'description': 'The percentage of subjects experiencing solicited local AEs (discomfort \\[eg, pain, burning\\], swelling, bruising, or itching at the investigational product injection site) during treatment with CSL830 and placebo.'}, {'measure': 'Injections Resulting in Solicited AEs (Injection Site Reactions)', 'timeFrame': 'During the treatment phase, up to 32 weeks.', 'description': 'The rate/injection of injections of C1-esterase inhibitor or placebo that were followed by solicited local AEs (discomfort \\[eg, pain, burning\\], swelling, bruising, or itching at the investigational product injection site) during treatment with CSL830 and placebo. Rate/Injection = Number of events/number of injections.'}]}, 'conditionsModule': {'keywords': ['Hereditary Angioedema'], 'conditions': ['Hereditary Angioedema Types I and II']}, 'referencesModule': {'references': [{'pmid': '28328347', 'type': 'RESULT', 'citation': 'Longhurst H, Cicardi M, Craig T, Bork K, Grattan C, Baker J, Li HH, Reshef A, Bonner J, Bernstein JA, Anderson J, Lumry WR, Farkas H, Katelaris CH, Sussman GL, Jacobs J, Riedl M, Manning ME, Hebert J, Keith PK, Kivity S, Neri S, Levy DS, Baeza ML, Nathan R, Schwartz LB, Caballero T, Yang W, Crisan I, Hernandez MD, Hussain I, Tarzi M, Ritchie B, Kralickova P, Guilarte M, Rehman SM, Banerji A, Gower RG, Bensen-Kennedy D, Edelman J, Feuersenger H, Lawo JP, Machnig T, Pawaskar D, Pragst I, Zuraw BL; COMPACT Investigators. Prevention of Hereditary Angioedema Attacks with a Subcutaneous C1 Inhibitor. N Engl J Med. 2017 Mar 23;376(12):1131-1140. doi: 10.1056/NEJMoa1613627.'}, {'pmid': '36326435', 'type': 'DERIVED', 'citation': 'Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.'}, {'pmid': '31485239', 'type': 'DERIVED', 'citation': 'Li HH, Zuraw B, Longhurst HJ, Cicardi M, Bork K, Baker J, Lumry W, Bernstein J, Manning M, Levy D, Riedl MA, Feuersenger H, Prusty S, Pragst I, Machnig T, Craig T; COMPACT Investigators. Subcutaneous C1 inhibitor for prevention of attacks of hereditary angioedema: additional outcomes and subgroup analysis of a placebo-controlled randomized study. Allergy Asthma Clin Immunol. 2019 Aug 28;15:49. doi: 10.1186/s13223-019-0362-1. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nRun-In Period Inclusion Criteria:\n\n* Males or females aged 12 years or older.\n* A clinical diagnosis of hereditary angioedema type I or II.\n* Hereditary angioedema attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment.\n* For subjects who have used oral therapy for prophylaxis against HAE attacks within 3 months of Screening: use of a stable regimen within 3 months of Screening, with no plans to change.\n\nEligibility Criteria for Entering Treatment Period 1:\n\n* Laboratory confirmation of type I or type II hereditary angioedema, including C1-esterase inhibitor functional activity less than 50% AND C4 antigen level below the laboratory reference range.\n* No clinically significant abnormalities as assessed using laboratory parameters.\n* During participation in the run-in period, subjects must have experienced hereditary angioedema attacks that required acute treatment, required medical attention, or caused significant functional impairment.\n\nExclusion Criteria:\n\nRun-In Period Exclusion Criteria:\n\n* History of clinical significant arterial or venous thrombosis, or current history of a clinically significant prothrombotic risk.\n* Incurable malignancies at screening.\n* Any clinical condition that will interfere with the evaluation of C1-esterase inhibitor therapy.\n* Clinically significant history of poor response to C1-esterase therapy for the management of hereditary angioedema.\n* Receiving therapy prohibited by the protocol, including medications for hereditary angioedema prophylaxis.\n* Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit.'}, 'identificationModule': {'nctId': 'NCT01912456', 'briefTitle': 'A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema', 'orgStudyIdInfo': {'id': 'CSL830_3001'}, 'secondaryIdInfos': [{'id': '2013-000916-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Higher-volume placebo, then low-volume C1-esterase inhibitor', 'description': 'A higher-volume dose of placebo will be administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of C1-esterase inhibitor will be administered subcutaneously twice a week for up to 16 weeks.', 'interventionNames': ['Biological: Low-volume C1-esterase inhibitor', 'Biological: Higher-volume placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low-volume C1-esterase inhibitor, then higher-volume placebo', 'description': 'A low-volume dose of C1-esterase inhibitor will be administered subcutaneously twice a week for up to 16 weeks, then a higher-volume dose of placebo will be administered subcutaneously twice a week for up to 16 weeks.', 'interventionNames': ['Biological: Low-volume C1-esterase inhibitor', 'Biological: Higher-volume placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low-volume placebo, then higher-volume C1-esterase inhibitor', 'description': 'A low-volume dose of placebo will be administered subcutaneously twice a week for up to 16 weeks then a higher-volume dose of C1-esterase inhibitor will be administered subcutaneously twice a week for up to 16 weeks.', 'interventionNames': ['Biological: Higher-volume C1-esterase inhibitor', 'Biological: Low-volume placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Higher-volume C1-esterase inhibitor, then low-volume placebo', 'description': 'A higher-volume dose of C1-esterase inhibitor will be administered subcutaneously twice a week for up to 16 weeks, then a low-volume dose of placebo will be administered subcutaneously twice a week for up to 16 weeks.', 'interventionNames': ['Biological: Higher-volume C1-esterase inhibitor', 'Biological: Low-volume placebo']}], 'interventions': [{'name': 'Low-volume C1-esterase inhibitor', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Higher-volume placebo, then low-volume C1-esterase inhibitor', 'Low-volume C1-esterase inhibitor, then higher-volume placebo']}, {'name': 'Higher-volume C1-esterase inhibitor', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Higher-volume C1-esterase inhibitor, then low-volume placebo', 'Low-volume placebo, then higher-volume C1-esterase inhibitor']}, {'name': 'Low-volume placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Higher-volume C1-esterase inhibitor, then low-volume placebo', 'Low-volume placebo, then higher-volume C1-esterase inhibitor']}, {'name': 'Higher-volume placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Higher-volume placebo, then low-volume C1-esterase inhibitor', 'Low-volume C1-esterase inhibitor, then higher-volume placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': 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-76.65025}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23452', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Study Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '2560', 'city': 'Campbelltown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Study Site', 'geoPoint': {'lat': -34.06667, 'lon': 150.81667}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Study Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 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