Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT01199705
Status:
COMPLETED
Last Update Posted:
2014-12-12
First Post:
2010-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005719', 'term': 'gamma-Globulins'}, {'id': 'C558471', 'term': 'Hizentra'}], 'ancestors': [{'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': 'Use email contact', 'title': 'Clinical Trial Disclosure Manager', 'organization': 'CSL Behring'}, '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': 'For the duration of the study, up to 36 weeks', 'description': 'The safety data set comprised all subjects treated with the study drug. All SAEs are presented including a pre-treatment SAE of gastroenteritis. In Other AEs, non-serious AEs starting at or after the first study drug infusion are presented. A total of 75 IVIG and 584 SCIG infusions of IgPro20 were administered to 25 subjects during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'IVIG Treatment', 'description': 'Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).', 'otherNumAtRisk': 25, 'otherNumAffected': 20, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'SCIG Treatment', 'description': 'IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.', 'otherNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Local reactions', 'notes': 'Local reactions cover MedDRA PTs: infusion site: discomfort, erythema, haemorrhage, induration, inflammation, pain, pruritus, swelling; injection site: erythema, extravasation, induration, irritation, pain, pruritus, swelling; puncture site reaction.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 160, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Conjunctivitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastroenteritis', 'notes': 'This SAE occurred between screening and the first IVIG dose and was thus non-treatment-emergent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'IgG Trough Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IgPro20 - Per Protocol Set (PPS)', 'description': 'The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.'}, {'id': 'OG001', 'title': 'IgPro20 - Full Analysis Set (FAS)', 'description': 'The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.09', 'groupId': 'OG000', 'lowerLimit': '1.06', 'upperLimit': '1.13'}, {'value': '1.11', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '1.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24', 'description': 'Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.', 'unitOfMeasure': 'Ratio of Geometric Means', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability. The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.'}, {'type': 'SECONDARY', 'title': 'Number of Infection Episodes (Serious and Non-serious) by Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IgPro20 - Per Protocol Set (PPS)', 'description': 'The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.'}, {'id': 'OG001', 'title': 'IgPro20 - Full Analysis Set (FAS)', 'description': 'The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.'}], 'classes': [{'title': 'IVIG Treatment', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'SCIG IgPro20 Treatment (Wash-in/Wash-out)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'SCIG IgPro20 Treatment (Efficacy)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 weeks', 'description': 'Number of infection episodes (serious and non-serious) presented by study period:\n\n* IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).\n* SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.\n* SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.', 'unitOfMeasure': 'Number of infection episodes', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}, {'units': 'Subject Study Days', 'counts': [{'value': '1209', 'groupId': 'OG000'}, {'value': '1764', 'groupId': 'OG001'}, {'value': '1840', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IVIG Treatment', 'description': 'Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).'}, {'id': 'OG001', 'title': 'SCIG Treatment (Wash-in/Wash-out)', 'description': 'Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.'}, {'id': 'OG002', 'title': 'SCIG Treatment (Efficacy)', 'description': 'Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.74', 'groupId': 'OG000'}, {'value': '5.79', 'groupId': 'OG001'}, {'value': '2.98', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)\n* SCIG IgPro20 treatment (efficacy) (12 weeks)', 'unitOfMeasure': 'Infections per subject year', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Study Days', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.'}, {'type': 'SECONDARY', 'title': 'Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}, {'units': 'Subject Study Days', 'counts': [{'value': '1396', 'groupId': 'OG000'}, {'value': '2016', 'groupId': 'OG001'}, {'value': '2095', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IVIG Treatment', 'description': 'Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).'}, {'id': 'OG001', 'title': 'SCIG Treatment (Wash-in/Wash-out)', 'description': 'Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.'}, {'id': 'OG002', 'title': 'SCIG Treatment (Efficacy)', 'description': 'Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.75', 'groupId': 'OG000'}, {'value': '5.79', 'groupId': 'OG001'}, {'value': '3.14', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)\n* SCIG IgPro20 treatment (efficacy) (12 weeks)', 'unitOfMeasure': 'Infections per subject year', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Study Days', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}, {'units': 'Subject Study Days', 'counts': [{'value': '1209', 'groupId': 'OG000'}, {'value': '1764', 'groupId': 'OG001'}, {'value': '1840', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IVIG Treatment', 'description': 'Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).'}, {'id': 'OG001', 'title': 'SCIG IgPro20 Treatment (Wash-in/Wash-out)', 'description': 'Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.'}, {'id': 'OG002', 'title': 'SCIG IgPro20 Treatment (Efficacy)', 'description': 'Weekly SC IgPro20 infusions for a 12-week efficacy period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}, {'value': '0.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Annualized Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '99', 'paramValue': '0.00', 'ciUpperLimit': '1.390', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Annualized Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '99', 'paramValue': '0.00', 'ciUpperLimit': '0.953', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Annualized Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '99', 'paramValue': '0.00', 'ciUpperLimit': '0.914', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)\n* SCIG IgPro20 treatment (efficacy; 12 weeks)', 'unitOfMeasure': 'SBIs per subject year', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Study Days', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.'}, {'type': 'SECONDARY', 'title': 'Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IgPro20 - Per Protocol Set (PPS)', 'description': 'The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.'}, {'id': 'OG001', 'title': 'IgPro20 - Full Analysis Set (FAS)', 'description': 'The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.'}], 'classes': [{'title': 'IVIG Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}, {'title': 'SCIG IgPro20 Treatment (Wash-in/Wash-out)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'SCIG IgPro20 Treatment (Efficacy)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 36 weeks', 'description': 'Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}, {'units': 'Subject Study Days', 'counts': [{'value': '1396', 'groupId': 'OG000'}, {'value': '2016', 'groupId': 'OG001'}, {'value': '2095', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IVIG Treatment', 'description': 'Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).'}, {'id': 'OG001', 'title': 'SCIG IgPro20 Treatment (Wash-in/Wash-out)', 'description': 'Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.'}, {'id': 'OG002', 'title': 'SCIG IgPro20 Treatment (Efficacy)', 'description': 'Weekly SC IgPro20 infusions for a 12-week efficacy period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}, {'value': '0.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Annualized Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '99', 'paramValue': '0.00', 'ciUpperLimit': '1.204', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001'], 'paramType': 'Annualized Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '99', 'paramValue': '0.00', 'ciUpperLimit': '0.834', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002'], 'paramType': 'Annualized Rate', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '99', 'paramValue': '0.00', 'ciUpperLimit': '0.802', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)\n* SCIG IgPro20 treatment (efficacy; 12 weeks)', 'unitOfMeasure': 'SBIs per subject year', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Subject Study Days', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.'}, {'type': 'SECONDARY', 'title': 'Number of Days of Hospitalization Due to Infections by Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IgPro20 - Per Protocol Set (PPS)', 'description': 'The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.'}, {'id': 'OG001', 'title': 'IgPro20 - Full Analysis Set (FAS)', 'description': 'The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.'}], 'classes': [{'title': 'IVIG Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1'}]}]}, {'title': 'SCIG IgPro20 Treatment (Wash-in/Wash-out)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '0'}]}]}, {'title': 'SCIG IgPro20 Treatment (Efficacy)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 36 weeks', 'description': 'Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Use of Antibiotics for Infection Prophylaxis and Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IgPro20 - Per Protocol Set (PPS)', 'description': 'The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.'}, {'id': 'OG001', 'title': 'IgPro20 - Full Analysis Set (FAS)', 'description': 'The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.'}], 'classes': [{'title': 'IVIG Treatment', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '64'}, {'value': '48.0', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '64'}]}]}, {'title': 'SCIG IgPro20 Treatment (Wash-in/Wash-out)', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '86'}, {'value': '35.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '86'}]}]}, {'title': 'SCIG IgPro20 Treatment (Efficacy)', 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '85'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 36 weeks', 'description': 'Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of All Adverse Events by Relatedness and Seriousness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IVIG Treatment', 'description': 'Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).'}, {'id': 'OG001', 'title': 'SCIG Treatment', 'description': 'IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '0.653', 'groupId': 'OG000'}, {'value': '0.457', 'groupId': 'OG001'}]}]}, {'title': 'At Least Possibly Related AEs', 'categories': [{'measurements': [{'value': '0.027', 'groupId': 'OG000'}, {'value': '0.296', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.002', 'groupId': 'OG001'}]}]}, {'title': 'At Least Possibly Related and Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For the duration of the study, up to 36 weeks', 'description': 'The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.', 'unitOfMeasure': 'AEs per infusion', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The safety data set (SDS) comprised all subjects treated with the study drug.'}, {'type': 'SECONDARY', 'title': 'Rate of Mild, Moderate, or Severe Local Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'units': 'Infusions', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '584', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IVIG Treatment', 'description': 'Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).'}, {'id': 'OG001', 'title': 'SCIG Treatment', 'description': 'IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.'}], 'classes': [{'title': 'Mild Local Reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.274', 'groupId': 'OG001'}]}]}, {'title': 'Moderate Local Reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe Local Reactions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For the duration of the study, up to 36 weeks', 'description': "In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.\n\nMild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity.", 'unitOfMeasure': 'AEs per infusion', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Infusions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The SDS comprised all subjects treated with the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IgPro20', 'description': 'Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume \\[w/v\\]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.'}], 'periods': [{'title': 'IVIG Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'SCIG Treatment (Wash-in/Wash-out)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Transfer of Residence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'SCIG Treatment (Efficacy)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This multicenter study enrolled subjects at nine of the participating study centers in Japan.', 'preAssignmentDetails': 'Screening took place 3 to 4 weeks prior to or at the first intravenous immunoglobulin (IVIG) infusion in the IVIG period of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'IgPro20', 'description': 'Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume \\[w/v\\]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'spread': '13.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 2 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '≥ 2 to < 12 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '≥ 12 to ≤ 16 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '> 16 to < 65 years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Immunodeficiency Type', 'classes': [{'title': 'Common Variable Immunodeficiency (CVID)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'X-Linked Agammaglobulinemia (XLA)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Autosomal Recessive Agammaglobulinemia (ARAG)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hyper-Immunoglobulin M (IgM) Syndrome', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-25', 'studyFirstSubmitDate': '2010-09-08', 'resultsFirstSubmitDate': '2013-01-01', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2014-12-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-18', 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Annualized Rate of Serious Bacterial Infections (SBIs), PPS Population', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)\n* SCIG IgPro20 treatment (efficacy; 12 weeks)'}, {'measure': 'Annualized Rate of Serious Bacterial Infections (SBIs), FAS Population', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate was based on the total number of SBIs and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks)\n* SCIG IgPro20 treatment (efficacy; 12 weeks)'}], 'primaryOutcomes': [{'measure': 'IgG Trough Level', 'timeFrame': 'During IVIG period (IV 1, IV 2, IV 3) and during SCIG period at weeks 16, 20, and 24', 'description': 'Geometric means of trough levels measured before 3 intravenous immunoglobulin (IVIG) infusions was compared with those of trough levels measured at steady-state for 3 subcutaneous immunoglobulin (SCIG) infusions (weeks 16, 20 and 24). The ratio of these geometric means was the primary outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Number of Infection Episodes (Serious and Non-serious) by Study Period', 'timeFrame': 'Up to 36 weeks', 'description': 'Number of infection episodes (serious and non-serious) presented by study period:\n\n* IVIG treatment: Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).\n* SCIG treatment (wash-in/wash-out; weeks 1 to 12): IgPro20 was administered subcutaneously with the first subcutaneous (SC) IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.\n* SCIG treatment (efficacy; weeks 13 to 24): After the SCIG wash-in/wash-out treatment, subjects were treated with weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.'}, {'measure': 'Rate of Infection Episodes (Serious and Non-serious) by Study Period, PPS Population', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)\n* SCIG IgPro20 treatment (efficacy) (12 weeks)'}, {'measure': 'Rate of Infection Episodes (Serious and Non-serious) by Study Period, FAS Population', 'timeFrame': 'Up to 36 weeks', 'description': 'The annualized rate of infection episodes (serious and non-serious) was based on the total number of infection episodes and the total number of subject study days for all subjects in the specified study periods (listed below) and analysis population and adjusted to 365 days.\n\nStudy periods:\n\n* IVIG treatment (up to 12 weeks)\n* SCIG IgPro20 treatment (wash-in/wash-out period) (12 weeks)\n* SCIG IgPro20 treatment (efficacy) (12 weeks)'}, {'measure': 'Number of Days Out of Work/School/Kindergarten/Day Care or Unable to Perform Normal Daily Activities Due to Infections by Study Period', 'timeFrame': 'Up to 36 weeks', 'description': 'Median number of days out of work/school/kindergarten/day care or unable to perform normal daily activities due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).'}, {'measure': 'Number of Days of Hospitalization Due to Infections by Study Period', 'timeFrame': 'Up to 36 weeks', 'description': 'Median number of days of hospitalization due to infections, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).'}, {'measure': 'Duration of Use of Antibiotics for Infection Prophylaxis and Treatment', 'timeFrame': 'Up to 36 weeks', 'description': 'Median number of days of use of antibiotics for infection prophylaxis and/or treatment, presented by study period: IVIG treatment (up to 12 weeks), SCIG IgPro20 treatment (wash-in/wash-out; 12 weeks), and SCIG IgPro20 treatment (efficacy; 12 weeks).'}, {'measure': 'Rate of All Adverse Events by Relatedness and Seriousness', 'timeFrame': 'For the duration of the study, up to 36 weeks', 'description': 'The rate of adverse events (AEs) was the number of treatment-emergent AEs over the number of infusions administered. At least possibly related AEs included possibly related AEs, probably related AEs, and related AEs.'}, {'measure': 'Rate of Mild, Moderate, or Severe Local Reactions', 'timeFrame': 'For the duration of the study, up to 36 weeks', 'description': "In addition to the standard MedDRA System Organ Class (SOC) AE assignments, the category of 'local reactions' was defined to provide the possibility for a combined analysis of local reactions and included AEs of: infusion site discomfort, infusion site erythema, infusion site haemorrhage, infusion site induration, infusion site inflammation, infusion site pain, infusion site pruritus, infusion site swelling, injection site erythema, injection site extravasation, injection site induration, injection site irritation, injection site pain, injection site pruritus, injection site swelling, and puncture site reaction.\n\nMild AE: Symptoms are easily tolerated and there is no interference with daily activities; Moderate AE: Discomfort enough to cause some interference with daily activities; Severe AE: Incapacitating with inability to work or do usual activity."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Immune globulin subcutaneous', 'SCIG', 'Primary immunodeficiency', 'PID'], 'conditions': ['Primary Immune Deficiency']}, 'referencesModule': {'references': [{'pmid': '25236916', 'type': 'BACKGROUND', 'citation': 'Igarashi A, Kanegane H, Kobayashi M, Miyawaki T, Tsutani K. Cost-minimization analysis of IgPro20, a subcutaneous immunoglobulin, in Japanese patients with primary immunodeficiency. Clin Ther. 2014 Nov 1;36(11):1616-24. doi: 10.1016/j.clinthera.2014.08.007. Epub 2014 Sep 16.'}, {'pmid': '24504846', 'type': 'RESULT', 'citation': 'Kanegane H, Imai K, Yamada M, Takada H, Ariga T, Bexon M, Rojavin M, Hu W, Kobayashi M, Lawo JP, Nonoyama S, Hara T, Miyawaki T. Efficacy and safety of IgPro20, a subcutaneous immunoglobulin, in Japanese patients with primary immunodeficiency diseases. J Clin Immunol. 2014 Feb;34(2):204-11. doi: 10.1007/s10875-013-9985-z. Epub 2014 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics of a subcutaneous immune globulin (SCIG; IgPro20) in subjects with primary immunodeficiency (PID). In addition, the study will assess the health-related quality of life and pharmacoeconomic aspects related to treatment with IgPro20.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy\n* Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent\n* Written informed consent\n\nExclusion Criteria:\n\n* Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy\n* Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening\n* Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma\n* Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening\n* Pregnancy or nursing mother\n* A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus\n* Participation in a study with other investigational product during this study and within 3 months prior to screening\n* Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study"}, 'identificationModule': {'nctId': 'NCT01199705', 'briefTitle': 'Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Multicenter Study of Efficacy, Safety, Tolerability, and Pharmacokinetics of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency', 'orgStudyIdInfo': {'id': 'ZLB06_002CR'}, 'secondaryIdInfos': [{'id': 'U1111-1116-6379', 'type': 'OTHER', 'domain': 'WHO Universal Trial Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IgPro20', 'interventionNames': ['Biological: Immune Globulin Subcutaneous (Human) (SCIG)']}], 'interventions': [{'name': 'Immune Globulin Subcutaneous (Human) (SCIG)', 'type': 'BIOLOGICAL', 'otherNames': ['Hizentra'], 'description': 'IgPro20 is a 20% (weight per volume \\[w/v\\]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.', 'armGroupLabels': ['IgPro20']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '260-8677', 'city': 'Chiba', 'state': 'Chiba Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '501-1194', 'city': 'Gifu', 'state': 'Gifu Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '060-8648', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '980-8574', 'city': 'Sendai', 'state': 'Miyagi Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '812-8582', 'city': 'Fukuoka City', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Study site'}, {'zip': '570-8507', 'city': 'Moriguchi', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 34.73333, 'lon': 135.56667}}, {'zip': '534-0021', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '343-8555', 'city': 'Koshigaya', 'state': 'Saitama Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.89035, 'lon': 139.78916}}, {'zip': '359-8513', 'city': 'Tokorozawa', 'state': 'Saitama Pref.', 'country': 'Japan', 'facility': 'Study site', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}], 'overallOfficials': [{'name': 'Yoriyuki Shiga', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}