Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-30 @ 5:24 AM
Study NCT ID:
NCT04566692
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2020-09-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081207', 'term': 'Primary Immunodeficiency Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}], 'ancestors': [{'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005719', 'term': 'gamma-Globulins'}, {'id': 'D002210', 'term': 'Caprylates'}], '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'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rhonda.griffin@grifols.com', 'phone': '+1 919 757 1744', 'title': 'Rhonda Griffin', 'organization': 'Grifols Therapeutics LLC'}, 'certainAgreement': {'otherDetails': "Site may publish results from the Study after 12 months of study completion date or after Grifols confirms there will be no joint, multi-center publication, then institution and/or investigator shall have the right, at their discretion, to publish, either in writing or orally, the results of the study performed under the protocol under certain conditions. At Sponsors' request, Site will remove any Confidential Information (other than Study results).", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Safety population included all participants who received at least 1 dose of IGSC 20%. The data for all-cause mortality, serious adverse events, and non-serious adverse events is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.', 'eventGroups': [{'id': 'EG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 4, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'IGSC 20%: Bi-weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 1, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Plantar fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Infusion site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Infusion site scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Vitamin B12 deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Skin mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': "Bartholin's cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': "Barrett's oesophagus", 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment-experienced Cohort: AUC of IGSC 20% Administered Weekly Assessed as: Steady-State AUC of Total IgG Over a Regular Dosing Interval (τ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}], 'classes': [{'categories': [{'measurements': [{'value': '167045.65', 'spread': '20.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and post dose at multiple time points after end of infusion up to Week 15', 'description': 'Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 7 days for participants on weekly IGSC 20% dosing. The data is reported for participants who received weekly dosing.', 'unitOfMeasure': 'hours*milligrams per deciliter (h*mg/dL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'PRIMARY', 'title': 'Treatment-experienced Cohort: AUC of IGSC 20% Administered Biweekly Assessed as Steady-State AUC of Total IgG Over a Biweekly Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Bi-Weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}], 'classes': [{'title': 'AUC (0-7 days)', 'categories': [{'measurements': [{'value': '170926.08', 'spread': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'AUC (0-14 days)', 'categories': [{'measurements': [{'value': '341852.17', 'spread': '21.1', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GLSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.035', 'ciLowerLimit': '1.0030', 'ciUpperLimit': '1.0685', 'groupDescription': 'Geometric least-squares means (GLSMs), GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participant as a random effect.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The bi-weekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \\> 0.8.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 14 days for participants on a biweekly IGSC 20% dosing. AUC (0-14 days) for the biweekly dosing were divided by 2 for comparison with AUC(0-7 days) for the weekly dosing prior to the statistical comparison. The data is reported for participants who received bi-weekly dosing.', 'unitOfMeasure': 'h*mg/dL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced Cohort: Cmax of Total IgG at Steady State Following IGSC 20% Weekly and Biweekly Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}, {'id': 'OG001', 'title': 'IGSC 20%: Bi-weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '1054.34', 'spread': '20.6', 'groupId': 'OG000'}, {'value': '1127.09', 'spread': '21.4', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'The observed maximum total IgG concentration following drug infusion obtained directly from the experimental data without interpolation. The data is reported for participants who received weekly and bi-weekly dosing', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced Cohort: Tmax of Total IgG at Steady State Given IGSC 20% Weekly and Biweekly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}, {'id': 'OG001', 'title': 'IGSC 20%: Bi-weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.650', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '123.03'}, {'value': '96.233', 'groupId': 'OG001', 'lowerLimit': '71.12', 'upperLimit': '264.73'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'The data is reported for participants who received weekly and bi-weekly dosing', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters AUC (0-7 days), Cmax, or Tmax.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced Cohort: Steady-State Mean Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}, {'id': 'OG001', 'title': 'IGSC 20%: Bi-weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}], 'classes': [{'categories': [{'measurements': [{'value': '978.29', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '960.53', 'spread': '20.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG001'], 'paramType': 'GLSM Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.970', 'ciLowerLimit': '0.9447', 'ciUpperLimit': '0.9957', 'groupDescription': 'GLSMs, GLSM ratio, and 90% CI of GLSM ratio were determined from a mixed-effect model for the log-transformed parameter value with treatment period (weekly or bi-weekly) as a fixed effect and participants as a random effect.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The biweekly treatment was considered non-inferior to the weekly treatment if the lower bound of the 90% CI was \\> 0.8.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'Mean Trough was calculated as the average of the trough concentrations at Weeks 12, 14 Pre-infusion, and 16 for the Weekly Period; and at Weeks 28, 30 Pre-infusion, and 32 for the Biweekly Period. Mean Trough for a given period was not calculated if at least one trough measure was missing. The data is reported for participants who received weekly and bi-weekly dosing.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'IgG population included all participants who received at least 1 dose of IGSC 20%.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Treatment-experienced Cohort', 'description': 'Participants first received 16 weekly doses of IGSC 20% using a SC infusion pump from Week 0 to Week 15. Participants entering study on IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF. Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '954.7', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'IgG Trough 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '825.7', 'spread': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1071.8', 'spread': '24.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1069.9', 'spread': '19.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1052.7', 'spread': '17.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1012.0', 'spread': '18.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '936.3', 'spread': '19.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '945.0', 'spread': '19.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1002.1', 'spread': '18.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '952.0', 'spread': '19.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '985.6', 'spread': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '978.8', 'spread': '22.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '933.8', 'spread': '20.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 32 (End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '966.6', 'spread': '19.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Screening, IgG Trough 2, Weeks 0, 2, 4, 8, 12, 14 (pre-infusion), 15, 16, 20, 24, 28, 30 (pre-infusion) and 32', 'description': 'IgG Trough 2 = For treatment-experienced participants entering the study on IVIG or Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA), a second IgG trough level was obtained after screening; this was summarized in the visit designated as IgG Trough 2. Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'IgG population included all participants who received at least 1 dose of IGSC 20%. Number analyzed is the number of participants with data available for analysis at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '201.2', 'spread': '99.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '183.3', 'spread': '96.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '957.5', 'spread': '29.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '856.5', 'spread': '33.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '875.3', 'spread': '25.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '843.5', 'spread': '22.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '879.1', 'spread': '24.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '902.4', 'spread': '20.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '946.2', 'spread': '18.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '953.9', 'spread': '16.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '933.7', 'spread': '21.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '938.6', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '955.5', 'spread': '15.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 32 (End of Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '930.6', 'spread': '19.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Screening, Weeks 0, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28 and 32', 'description': 'Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'IgG population included all participants who received at least 1 dose of IGSC 20%. Number analyzed is the number of participants with data available for analysis at specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced and Treatment-naïve Cohorts: Number of Participants With Serious Bacterial Infection (SBI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Treatment-experienced Cohort', 'description': 'Participants first received 16 weekly doses of IGSC 20% using a SC infusion pump from Week 0 to Week 15. Participants entering study on IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF. Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}, {'id': 'OG001', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Infections of Any Kind as Determined by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}, {'id': 'OG001', 'title': 'IGSC 20%: Bi-Weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}, {'id': 'OG002', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.299', 'groupId': 'OG000', 'lowerLimit': '1.203', 'upperLimit': '4.389'}, {'value': '1.995', 'groupId': 'OG001', 'lowerLimit': '1.033', 'upperLimit': '3.858'}, {'value': '2.507', 'groupId': 'OG002', 'lowerLimit': '1.198', 'upperLimit': '5.247'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. All infections of any kind included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the investigator. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.', 'unitOfMeasure': 'rate of events per participant per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Validated Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}, {'id': 'OG001', 'title': 'IGSC 20%: Bi-weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}, {'id': 'OG002', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.511', 'groupId': 'OG000', 'lowerLimit': '0.210', 'upperLimit': '1.244'}, {'value': '0.587', 'groupId': 'OG001', 'lowerLimit': '0.213', 'upperLimit': '1.615'}, {'value': '0.279', 'groupId': 'OG002', 'lowerLimit': '0.054', 'upperLimit': '1.427'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. A validated treatment-emergent infection was documented by positive radiograph, fever (\\>38°C oral or \\>39°C rectal), culture, or diagnostic testing for microorganisms e.g., bacterial, viral, fungal, or protozoal pathogens (e.g., rapid streptococcal antigen detection test). Treatment-emergent infection was defined as an infection with onset on or after first infusion start date/time. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.', 'unitOfMeasure': 'rate of events per participant per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Days Per Participant Per Year That Participants Were on Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}, {'id': 'OG001', 'title': 'IGSC 20%: Bi-weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}, {'id': 'OG002', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}], 'classes': [{'title': 'Prophylactic Antibiotics', 'categories': [{'measurements': [{'value': '15.326', 'groupId': 'OG000', 'lowerLimit': '5.975', 'upperLimit': '39.278'}, {'value': '15.258', 'groupId': 'OG001', 'lowerLimit': '6.035', 'upperLimit': '38.603'}, {'value': '0.00', 'comment': 'Upper limit of 95% CI was not evaluable due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '0.000', 'upperLimit': 'NA'}]}]}, {'title': 'Therapeutic Antibiotics', 'categories': [{'measurements': [{'value': '19.796', 'groupId': 'OG000', 'lowerLimit': '10.493', 'upperLimit': '37.316'}, {'value': '10.681', 'groupId': 'OG001', 'lowerLimit': '5.241', 'upperLimit': '21.779'}, {'value': '23.120', 'groupId': 'OG002', 'lowerLimit': '8.313', 'upperLimit': '64.323'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.', 'unitOfMeasure': 'rate of days per participant per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.'}, {'type': 'SECONDARY', 'title': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Hospitalizations Per Participant Per Year Due to Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IGSC 20%: Weekly Dosing', 'description': 'Participants received 16 weekly doses of IGSC 20% from Week 0 to Week 15 using a SC infusion pump. Participants entering study IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF.'}, {'id': 'OG001', 'title': 'IGSC 20%: Bi-weekly Dosing', 'description': 'Participants received 9 biweekly doses of IGSC 20 % (i.e., IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}, {'id': 'OG002', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.128', 'groupId': 'OG000', 'lowerLimit': '0.048', 'upperLimit': '0.340'}, {'value': '0.117', 'groupId': 'OG001', 'lowerLimit': '0.043', 'upperLimit': '0.323'}, {'value': '0.000', 'comment': 'Upper limit of 95% CI was not evaluable due to insufficient number of participants with events.', 'groupId': 'OG002', 'lowerLimit': '0.000', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of hospitalizations per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.', 'unitOfMeasure': 'rate of events per participant per year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'IGSC 20%: Treatment-experienced Cohort', 'description': 'Participants first received 16 weekly doses of IGSC 20% using a subcutaneous (SC) infusion pump from Week 0 to Week 15. Participants entering study on intravenous immune globulin (IVIG), IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on subcutaneous immunoglobulin (SCIG) received the same milligram/kilogram (mg/kg) equivalent weekly dose as given prior to study entry, without using a dose adjustment factor (DAF). Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}, {'id': 'FG001', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Safety Population', 'comment': 'Safety population included all participants who received at least 1 dose of IGSC 20%.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Efficacy Evaluable Population', 'comment': 'Efficacy evaluable population included all participants who received at least 1 dose of IGSC 20%.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'IgG Population', 'comment': 'IgG population included all participants who received at least 1 dose of IGSC 20%.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Pharmacokinetic (PK) Population', 'comment': 'PK population included all the participants who had sufficient PK concentration data to have at least one of the PK parameters: area under the concentration time curve (AUC) (0-7 days), maximum concentration (Cmax), or time to reach Cmax (Tmax).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants with primary immunodeficiency were enrolled at 15 investigative centers in the United States from 24 November 2020 to 25 July 2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'IGSC 20%: Treatment-experienced Cohort', 'description': 'Participants first received 16 weekly doses of IGSC 20% using a SC infusion pump from Week 0 to Week 15. Participants entering study on IVIG, IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on SCIG received the same mg/kg equivalent weekly dose as given prior to study entry, without using a DAF. Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.'}, {'id': 'BG001', 'title': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '12.06', 'groupId': 'BG000'}, {'value': '56.0', 'spread': '8.25', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '11.47', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least 1 dose of IGSC 20%.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-17', 'size': 20976993, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-14T03:01', 'hasProtocol': True}, {'date': '2022-02-02', 'size': 7462995, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-13T04:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single sequence crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-13', 'studyFirstSubmitDate': '2020-09-22', 'resultsFirstSubmitDate': '2023-07-14', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-14', 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-experienced Cohort: AUC of IGSC 20% Administered Weekly Assessed as: Steady-State AUC of Total IgG Over a Regular Dosing Interval (τ)', 'timeFrame': 'Predose and post dose at multiple time points after end of infusion up to Week 15', 'description': 'Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 7 days for participants on weekly IGSC 20% dosing. The data is reported for participants who received weekly dosing.'}, {'measure': 'Treatment-experienced Cohort: AUC of IGSC 20% Administered Biweekly Assessed as Steady-State AUC of Total IgG Over a Biweekly Dosing Interval', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'Area under the concentration vs. time curve at steady state over the dosing interval (from time 0 to τ), was calculated by a combination of linear and logarithmic trapezoidal methods. The linear trapezoidal method was used for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method was used for those arising from decreasing concentrations. The dose interval τ was 14 days for participants on a biweekly IGSC 20% dosing. AUC (0-14 days) for the biweekly dosing were divided by 2 for comparison with AUC(0-7 days) for the weekly dosing prior to the statistical comparison. The data is reported for participants who received bi-weekly dosing.'}], 'secondaryOutcomes': [{'measure': 'Treatment-experienced Cohort: Cmax of Total IgG at Steady State Following IGSC 20% Weekly and Biweekly Administration', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'The observed maximum total IgG concentration following drug infusion obtained directly from the experimental data without interpolation. The data is reported for participants who received weekly and bi-weekly dosing'}, {'measure': 'Treatment-experienced Cohort: Tmax of Total IgG at Steady State Given IGSC 20% Weekly and Biweekly', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'The data is reported for participants who received weekly and bi-weekly dosing'}, {'measure': 'Treatment-experienced Cohort: Steady-State Mean Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration', 'timeFrame': 'Predose and post dose at multiple timepoints after end of infusion up to Week 32', 'description': 'Mean Trough was calculated as the average of the trough concentrations at Weeks 12, 14 Pre-infusion, and 16 for the Weekly Period; and at Weeks 28, 30 Pre-infusion, and 32 for the Biweekly Period. Mean Trough for a given period was not calculated if at least one trough measure was missing. The data is reported for participants who received weekly and bi-weekly dosing.'}, {'measure': 'Treatment-experienced Cohort: Individual Trough Concentration of Total IgG Following IGSC 20% Weekly and Biweekly Administration', 'timeFrame': 'Screening, IgG Trough 2, Weeks 0, 2, 4, 8, 12, 14 (pre-infusion), 15, 16, 20, 24, 28, 30 (pre-infusion) and 32', 'description': 'IgG Trough 2 = For treatment-experienced participants entering the study on IVIG or Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (HYQVIA), a second IgG trough level was obtained after screening; this was summarized in the visit designated as IgG Trough 2. Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.'}, {'measure': 'Treatment-naïve Cohorts: Individual Trough Concentration of Total IgG', 'timeFrame': 'Screening, Weeks 0, 1, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28 and 32', 'description': 'Week 0 = Participants entering IVIG or HYQVIA, the first IGSC 20% dose was approximately 1 week post last IVIG/HYQVIA dose and so IgG at Week 0 for these participants represented a pre-dose value. For participants entering on all other forms of SCIG, the Week 0 value is true trough.'}, {'measure': 'Treatment-experienced and Treatment-naïve Cohorts: Number of Participants With Serious Bacterial Infection (SBI)', 'timeFrame': 'From screening up to final follow up visit at Week 33'}, {'measure': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Infections of Any Kind as Determined by the Investigator', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. All infections of any kind included serious/nonserious including acute sinusitis, exacerbation of chronic sinusitis, acute otitis media, pneumonia, acute bronchitis, infectious diarrhea etc.) as determined by the investigator. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.'}, {'measure': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Events Per Participant Per Year With Validated Infections', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of events per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. A validated treatment-emergent infection was documented by positive radiograph, fever (\\>38°C oral or \\>39°C rectal), culture, or diagnostic testing for microorganisms e.g., bacterial, viral, fungal, or protozoal pathogens (e.g., rapid streptococcal antigen detection test). Treatment-emergent infection was defined as an infection with onset on or after first infusion start date/time. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.'}, {'measure': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Days Per Participant Per Year That Participants Were on Antibiotics', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of days per person per year is calculated as the total number of days divided by the total duration of exposure in years across all participants. Antibiotics included prophylactic and therapeutic. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.'}, {'measure': 'Treatment-experienced and Treatment-naïve Cohorts: Rate of Hospitalizations Per Participant Per Year Due to Infection', 'timeFrame': 'From screening up to final follow up visit at Week 33', 'description': 'Rate of hospitalizations per participant per year was calculated as the total number of events divided by the total duration of exposure in years across all participants. Hospitalization was considered only in cases of hospital admission (including emergency room stay) for equal or more than 24 hours. The data is reported for participants in the treatment-naive cohort and the participants who received weekly and bi-weekly dosing.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunologic Deficiency Syndromes', 'Immune System Diseases', 'Immunoglobulins'], 'conditions': ['Primary Immunodeficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether biweekly (every 2 weeks) administration of Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified (IGSC 20%) produces a steady-state area under the concentration versus time curve (AUC) of total Immunoglobulin G (IgG) that is non-inferior to that produced by weekly administration of IGSC 20% in treatment-experienced participants with primary immunodeficiency (PI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria only for Treatment-Experienced Participants\n\n* Participants 18 years to 75 years (inclusive) at screening\n* Participants with documented and confirmed pre-existing diagnosis of Primary Immunodeficiency (PI) with features of hypogammaglobulinemia requiring Immunoglobulin G (IgG) replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (example, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (example, hyper immunoglobulin M immunodeficiency syndrome).\n* Participants have not had an Serious bacterial infection (SBI) or been hospitalized for infection of any etiology (example, viral, fungal, parasitic) within the last 3 months prior to screening or during screening.\n* Participants currently receiving IgG replacement therapy for ≥3 months via Intravenous (IV) or SC infusion. Participants receiving IVIG prior to study must receive a dosage of at least 200 mg/kg per infusion.\n* Participants whose screening IgG trough levels must be ≥500 milligram per deciliter (mg/dL).\n* Participants have signed an informed consent form.\n\nInclusion Criteria only for Treatment-Naïve Participants\n\n* Participants 6 years to 75 years (inclusive) at screening.\n* Participants with documented and confirmed diagnosis of PI with features of hypogammaglobulinemia requiring IgG replacement therapy including but not limited to the following humoral-based immunodeficiency syndromes (example, X-linked agammaglobulinemia, common variable immunodeficiency), and combined immunodeficiency syndromes without lymphocytopenia (example, hyper immunoglobulin M immunodeficiency syndrome).\n* Participants have never received IgG replacement treatment (ie, no prior immune globulin replacement therapy).\n* Participants whose screening IgG level must be ≤400 mg/dL.\n* Participants do not have an SBI nor requires hospitalization for infection of any etiology (example, viral, fungal, parasitic) during screening or at baseline.\n* Participants have signed an informed consent.\n\nExclusion Criteria:\n\n* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the participant at undue medical risk.\n* Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.\n* Participants who have a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study.\n* Participants have known isolated IgG subclass deficiency; isolated specific antibody deficiency (SAD) or selective IgG deficiency; or transient hypogammaglobulinemia of infancy.\n* Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA).\n* Participants have significant proteinuria (≥3+ or known urinary protein loss \\>1 gram g/24 hours or nephrotic syndrome), has acute renal failure, is on dialysis, and/or has severe renal impairment on Screening laboratory testing (blood urea nitrogen \\[BUN\\] or creatinine more than 2.5 times the upper limit of normal \\[ULN\\]).\n* Participants have screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding more than 2.5 times the ULN for the expected normal range for the testing laboratory.\n* Participants have hemoglobin \\<9 gram per deciliter (g/dL) at screening.\n* Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident or transient ischemic attack) or deep venous thrombosis.\n* Participants are currently receiving anti-coagulation therapy which would make SC administration inadvisable (vitamin K antagonists, nonvitamin K antagonist oral anticoagulants \\[example, dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa\\], and parenteral anticoagulants \\[example, fondaparinux\\]).\n* Participants currently have a known hyperviscosity syndrome.\n* Participants have an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/microliter (μL) \\[1.0 x10\\^9/L\\]), or human immunodeficiency virus infection/acquired immune deficiency syndrome.\n* Participants have a known previous infection with or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.\n* Participants are receiving any of the following medications: (a) immunosuppressants including chemotherapeutic agents; (b) immunomodulators; (c) long-term systemic corticosteroids defined as daily dose \\>1 mg of prednisone equivalent/kg/day for \\>30 days. Note: Intermittent courses of corticosteroids of not more than 10 days would not exclude a participant. Inhaled or topical corticosteroids are allowed.\n* Participants (if \\<18 years of age) have non-controlled arterial hypertension at a level of greater than or equal to the 90th percentile blood pressure (either systolic or diastolic) for their age and height or the adult participant has non-controlled arterial hypertension (systolic blood pressure \\[SBP\\] \\>160 millimeter per mercury (mmHg) and/or diastolic blood pressure \\[DBP\\] \\>100 mmHg).'}, 'identificationModule': {'nctId': 'NCT04566692', 'briefTitle': 'A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grifols Therapeutics LLC'}, 'officialTitle': 'A Multi-center, Single-Sequence, Open-label Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Subjects and Loading/Maintenance Dosing in Treatment-Naïve Subjects With Primary Immunodeficiency', 'orgStudyIdInfo': {'id': 'GC1906'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IGSC 20%: Treatment-experienced Cohort', 'description': 'Participants first received 16 weekly doses of IGSC 20% using a subcutaneous (SC) infusion pump from Week 0 to Week 15. Participants entering study on intravenous immune globulin (IVIG), IGSC 20% was dosed at 1.37 times the equivalent weekly dose and participants entering on subcutaneous immunoglobulin (SCIG) received the same milligram/kilogram (mg/kg) equivalent weekly dose as given prior to study entry, without using a dose adjustment factor (DAF). Participants then received 9 biweekly doses of IGSC 20 % (i.e, IGSC 20% every 2 weeks) using an SC infusion pump, with the first IGSC 20% dose administered at Week 16 and the final dose given at Week 32.', 'interventionNames': ['Biological: IGSC 20%']}, {'type': 'EXPERIMENTAL', 'label': 'IGSC 20%: Treatment-naïve Cohort', 'description': 'Treatment-naïve participants received a loading dose of 150 mg/kg/day of IGSC 20% for 5 consecutive days (Week 0, Days 1 to 5) followed by weekly maintenance infusions of 150 mg/kg IGSC 20% starting Week 1 (Day 8) through Week 32. IGSC 20% infusion was administered using an SC infusion pump.', 'interventionNames': ['Biological: IGSC 20%']}], 'interventions': [{'name': 'IGSC 20%', 'type': 'BIOLOGICAL', 'otherNames': ['Immune Globulin Subcutaneous (Human), 20% Caprylate/Chromatography Purified'], 'description': 'SC infusion pump.', 'armGroupLabels': ['IGSC 20%: Treatment-experienced Cohort', 'IGSC 20%: Treatment-naïve Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Center of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85340', 'city': 'Litchfield Park', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Solutions of Arizona, PC', 'geoPoint': {'lat': 33.49337, 'lon': -112.35794}}, {'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': '31707', 'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'Allergy & Asthma Clinics of Georgia, P.C.', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Institute for Asthma and Allergy', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Optimed Research LTD', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Allergy, Asthma and Clinical Research Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73131', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Institute of Allergy and Asthma Clinical Research', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Vital Prospect Clinical Research Institute', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allergy and Clinical Immunology Associates', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'AARA Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grifols Therapeutics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}