Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-19 @ 8:59 PM
Study NCT ID:
NCT01581593
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D000361', 'term': 'Agammaglobulinemia'}], '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'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.calcinai@kedrion.com', 'phone': '+393486559761', 'title': 'Dr. Mirella Calcinai, MD, Clinical Research Director', 'organization': 'Kedrion S.p.A'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '13 months', 'eventGroups': [{'id': 'EG000', 'title': 'Kedrion IVIG 10%', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Duration - 12 months', 'otherNumAtRisk': 45, 'otherNumAffected': 44, 'seriousNumAtRisk': 45, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 22, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Viral Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Acute Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 22, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 21, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 18, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Eye Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Immune System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}], 'seriousEvents': [{'term': 'Bacterial pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Humerus Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA SOC'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Acute, Serious Bacterial Infections in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Infusion Schedule', 'description': 'Kedrion IVIG 10% treatment 21 and 28-day infusion schedule\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.11'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '13 months', 'description': 'The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis, meeting EMA and FDA criteria.', 'unitOfMeasure': "ASBI's/person-year", 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Infusion Schedule', 'description': 'Kedrion IVIG 10% treatment 21 and 28-day infusion schedule\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Treatment duration - 12 months'}], 'classes': [{'title': 'Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Sinusitis', 'categories': [{'measurements': [{'value': '0.48', 'groupId': 'OG000'}]}]}, {'title': 'Viral upper respiratory tract infection', 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Rhinitis', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Acute sinusitis', 'categories': [{'measurements': [{'value': '0.15', 'groupId': 'OG000'}]}]}, {'title': 'Gastroenteritis viral', 'categories': [{'measurements': [{'value': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Herpes zoster', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Urinary tract infection', 'categories': [{'measurements': [{'value': '0.11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '13 months', 'unitOfMeasure': "infect./subject's study duration (years)", 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days Out of Work/School/Daycare Due to Infection in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 & 28 Days Treatment Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '6.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Infusion Schedule', 'description': 'Kedrion IVIG 10% treatment 21 and 28-day infusion schedule\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '6.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days on Therapeutic Antibiotics in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Infusion Schedule', 'description': 'Kedrion IVIG 10% treatment 21 and 28-day infusion schedule\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '23.3', 'spread': '33.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Unscheduled Visits to Physicians in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Infusion Schedule', 'description': 'Kedrion IVIG 10% treatment 21 and 28-day infusion schedule\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '1.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Hospitalizations Due to Infection in ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 & 28 Days Treatment Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'title': '0 hospitalizations', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': '1 hospitalization', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '2 hospitalizations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '≥ 3 hospitalizations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days of Hospitalization Due to Infection in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 & 28 Days Treatments Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Yearly Hospitalization Rate Due to Infection in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 & 28 Days Treatments Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.11', 'spread': '0.436', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'hospitalizations per year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Yearly Hospitalization Duration Due to Infection in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 & 28 Days Treatments Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '2.196', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Distribution of All-cause Hospitalizations in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Treatment Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'title': '0 hospitalizations', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}, {'title': '1 hospitalization', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '2 hospitalizations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '3 hospitalizations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '≥ 4 hospitalizations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of All-cause Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Treatment Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'spread': '12.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The duration of the hospitalizations was measured for each of four subjects who were hospitalized and was calculated dividing by the subject's study duration in days."}, {'type': 'SECONDARY', 'title': 'Distribution of Fever Episodes in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Treatment Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'title': '0 fever episodes', 'measurements': [{'value': '34', 'groupId': 'OG000'}]}, {'title': '1 fever episode', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '2 fever episodes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': '3 fever episodes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '4 fever episodes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': '5 fever episodes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '13 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Fever Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Treatment Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'spread': '4.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The duration of fever episodes was measured for each of eleven subjects who experienced this event.'}, {'type': 'SECONDARY', 'title': 'IgG Trough Levels at Steady State in the Total ITT Population.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Treatment Schedule', 'description': 'Kedrion IVIG 10% treatment.\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months'}], 'classes': [{'categories': [{'measurements': [{'value': '888', 'spread': '197', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '13 months', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Kedrion IVIG 10% 21 and 28 Days Infusion Schedule', 'description': 'Kedrion IVIG 10% treatment 21 and 28-day infusion schedule\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Duration - 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Kedrion IVIG 10% 21 and 28 Day Infusion Schedule', 'description': 'Kedrion IVIG 10% 21 and 28 Day infusion schedule\n\nKedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 or 28 days; Treatment duration - 12 months'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.9', 'spread': '20.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2014-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2012-04-16', 'resultsFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2012-04-19', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-29', 'studyFirstPostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Acute, Serious Bacterial Infections in the Total ITT Population.', 'timeFrame': '13 months', 'description': 'The incidence of acute serious bacterial infections, e.g. bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, osteomyelitis/septic arthritis, meeting EMA and FDA criteria.'}], 'secondaryOutcomes': [{'measure': 'Infections Other Than Acute, Serious Bacterial Infections (ASBIs) in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Days Out of Work/School/Daycare Due to Infection in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Days Unable to Perform Normal Daily Activities Due to Infection in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Days on Therapeutic Antibiotics in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Days of Unscheduled Visits to Physicians in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Number of Hospitalizations Due to Infection in ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Days of Hospitalization Due to Infection in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Yearly Hospitalization Rate Due to Infection in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Yearly Hospitalization Duration Due to Infection in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Distribution of All-cause Hospitalizations in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Duration of All-cause Hospitalizations', 'timeFrame': '13 months'}, {'measure': 'Distribution of Fever Episodes in the Total ITT Population.', 'timeFrame': '13 months'}, {'measure': 'Duration of Fever Episodes', 'timeFrame': '13 months'}, {'measure': 'IgG Trough Levels at Steady State in the Total ITT Population.', 'timeFrame': '13 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Primary Immunodeficiency', 'PID', 'Agammaglobulinemia', 'Hypogammaglobulinemia', 'Antibody deficiency'], 'conditions': ['Primary Immunodeficiency', 'Agammaglobulinemia', 'Hypogammaglobulinemia', 'Antibody Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).', 'detailedDescription': 'People with primary immunodeficiency diseases (PID) have a defective immune system and experience recurrent protozoal, bacterial, fungal and viral infections. Antibody deficiencies make up the largest group of PIDs.\n\nThe standard care for patients with PID is replacement immunoglobulin (a class of antibodies) solution. Prophylactic treatment with intravenous immunoglobulin (IVIG) solution has been shown to increase the time free from serious infection.\n\nKedrion IVIG 10% is a new preparation of an immunoglobulin G (IgG) solution. Kedrion IVIG 10% will be given by IV infusion to all study participants. The data collected will help determine whether Kedrion IVIG 10% is suitable for treating PID subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed clinical diagnosis of a Primary Immunodeficiency Disease\n* Male or female, ages 2 to 70 years\n* Received 300-900 mg/kg of a licensed IVIG therapy at 21 or 28 day intervals for at least 3 months prior to this study\n* 2 documented IgG trough levels of ≥ 5 g/L are obtained at two infusion cycles (21 or 28 days) within 12 months (one must be within 6 months) prior to study enrolment\n* Non-pregnant females of child-bearing potential who agree to use adequate birth control during the study\n* Subject is willing to comply with the protocol\n* Authorization to access personal health information.\n* Signed the informed consent form and a child assent form, if appropriate.\n* If currently participating in a clinical trial with another experimental IVIG may be enrolled if they have received stable IVIG therapy for at least 3 infusion cycles prior to receiving Kedrion IVIG 10% and all inclusion and exclusion criteria are satisfied\n* If currently participating in a trial of SCIG can be enrolled if they are switched to IVIG for three infusion cycles (21 or 28 days) prior to enrolment in this study\n\nExclusion Criteria:\n\n* Has secondary immunodeficiency.\n* Newly diagnosed and has not been treated with immunoglobulin or has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency.\n* Has a history of repeated reactions or hypersensitivity to IVIG or other injectable forms of IgG.\n* Has a history of thrombotic events defined by at least 1 event in subject's lifetime.\n* Has IgA deficiency and is known to have antibodies to IgA.\n* Has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrolment.\n* Has significant protein losing enteropathy, nephrotic syndrome or lymphangiectasia.\n* Has an acute infection as documented by culture or diagnostic imaging and/or a body temperature exceeding 38.5 °C (101.3 °F) within 7 days prior to screening\n* Has a known history or is positive at enrolment for human immunodeficiency virus (HIV) type 1 by NAT, hepatitis B virus (HBsAg and NAT), hepatitis C virus (by NAT), or hepatitis A virus (by NAT).\n* Has levels of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2.5 times of the upper limit of normal for the laboratory designated for the study.\n* Has an implanted venous access device\n* Has profound anemia or persistent severe neutropenia (≤ 1000 neutrophils per mm3)or lymphopenia of less than 500 cells per microliter.\n* Has a severe chronic condition such as renal failure (creatinine concentration \\> 2.0 times the upper limit of normal) with proteinuria, congestive heart failure (New York Heart Association III/IV), cardiomyopathy, cardiac arrhythmia associated with thromboembolic events (e.g. atrial fibrillation), unstable or advanced ischemic heart disease, hyperviscosity, or any other condition that the investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.\n* Has a history of a malignant disease other than properly treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin within 24 months prior to enrolment.\n* Has history of epilepsy or multiple episodes of migraine (defined as at least one episode within 6 months of enrolment) not completely controlled by medication.\n* Is receiving steroids (oral or parenteral daily dose of ≥ 0.15 mg/kg/day of prednisone or equivalent) OR other immunosuppressive drugs or chemotherapy.\n* Females who are pregnant, breast feeding or planning a pregnancy during the course of the study. Women who become pregnant during the study will be withdrawn from the study.\n* Has participated in another clinical study within 3 weeks prior to study enrolment."}, 'identificationModule': {'nctId': 'NCT01581593', 'briefTitle': 'Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kedrion S.p.A.'}, 'officialTitle': 'Multicenter, Open-label, Historically Controlled, Phase III Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Kedrion IVIG 10% in Adult and Pediatric Subjects With Primary Immunodeficiency (PID).', 'orgStudyIdInfo': {'id': 'KB052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kedrion IVIG 10%', 'description': 'Kedrion IVIG 10% treatment.', 'interventionNames': ['Biological: Kedrion IVIG 10%']}], 'interventions': [{'name': 'Kedrion IVIG 10%', 'type': 'BIOLOGICAL', 'description': 'Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months', 'armGroupLabels': ['Kedrion IVIG 10%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33408', 'city': 'North Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Allergy Associates of the Palm Beaches', 'geoPoint': {'lat': 26.81756, 'lon': -80.08199}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Family Allergy & Asthma Center, PC', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '55446', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Midwest Immunology Clinic', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'AAIR Research Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Optimed Research, LTD', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Dallas Allergy Immunology Research', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'AARA Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University Health Systems', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Marycliff Allergy Specialists', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'M4V1R2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Gordon Sussman Clinical Research Inc.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G1E2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pediatric & Adult Allergy & Clinical Immunology', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Mirella Calcinai, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kedrion SpA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kedrion S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}