Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-04 @ 7:51 PM
Study NCT ID:
NCT01651351
Status:
COMPLETED
Last Update Posted:
2021-05-25
First Post:
2012-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GLASSIA Infusion Rate Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019896', 'term': 'alpha 1-Antitrypsin Deficiency'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D013352', 'term': 'Subcutaneous Emphysema'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000515', 'term': 'alpha 1-Antitrypsin'}], 'ancestors': [{'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D015843', 'term': 'Serpins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000209', 'term': 'Acute-Phase Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000510', 'term': 'Alpha-Globulins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'PI may not publish without the prior written consent of Sponsor', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Simultaneous infusion of GLASSIA and placebo did not allow adverse events (AEs) to be unquestionably ascribed to either one. Any observed AE which was assessed by the investigator as related to treatment was conservatively attributed to GLASSIA.'}}, 'adverseEventsModule': {'timeFrame': 'Throughout the study period of 105 days per participant', 'eventGroups': [{'id': 'EG000', 'title': 'GLASSIA Infusion Rate- 0.04 mL/kg/Min', 'description': 'Participants who received simultaneous infusions of: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min', 'otherNumAtRisk': 30, 'otherNumAffected': 8, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GLASSIA Infusion Rate- 0.2 mL/kg/Min', 'description': 'Participants who received simultaneous infusions of: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min', 'otherNumAtRisk': 30, 'otherNumAffected': 4, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min'}, {'id': 'OG001', 'title': 'GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Day 15', 'unitOfMeasure': 'Infusions', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min'}, {'id': 'OG001', 'title': 'GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 1 hour of infusion completion', 'description': 'Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment', 'unitOfMeasure': 'Infusions', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min'}, {'id': 'OG001', 'title': 'GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours of the end of infusion', 'description': 'Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment', 'unitOfMeasure': 'Infusions', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min'}, {'id': 'OG001', 'title': 'GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 72 hours of the end of infusion', 'description': 'Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment', 'unitOfMeasure': 'Infusions', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min'}, {'id': 'OG001', 'title': 'GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 and Day 15', 'description': 'Number of AEs that occurred during an infusion and were deemed related to study product administration', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min'}, {'id': 'OG001', 'title': 'GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 hours post infusion to 14 days post infusion', 'description': 'Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Study Participants'}], 'classes': [{'title': 'HAV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HBV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HCV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'PVB19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'HIV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '105 days', 'description': 'Number of participants with seroconversion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': 'Day 1: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Day 15: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration. Placebo: Human albumin 2.5%: Intravenous administration'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'Day 1: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Day 15: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration. Placebo: Human albumin 2.5%: Intravenous administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment was conducted in the U.S at 1 study site. The first participant was enrolled in July 2012.', 'preAssignmentDetails': 'Thirty five healthy potential participants were enrolled at the clinical study site. Four were screen failures, and one was a back up participant who did not participate. Therefore, 30 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'Day 1: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Day 15: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Placebo: Human albumin 2.5%: Intravenous administration'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'Day 1: - GLASSIA at 0.2 mL/kg/min - Placebo at 0.04 mL/kg/min Day 15: - GLASSIA at 0.04 mL/kg/min - Placebo at 0.2 mL/kg/min Placebo: Human albumin 2.5%: Intravenous administration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27', 'spread': '8', 'groupId': 'BG000'}, {'value': '29', 'spread': '13', 'groupId': 'BG001'}, {'value': '28', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2014-01-31', 'completionDateStruct': {'date': '2013-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2012-07-23', 'dispFirstSubmitQcDate': '2014-01-31', 'resultsFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2012-07-25', 'dispFirstPostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-05-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-29', 'studyFirstPostDateStruct': {'date': '2012-07-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Infusions Associated With a Reduction in Infusion Rate or Discontinuation of Infusion Due to an Adverse Event (Regardless of Adverse Event Causality Assessment)', 'timeFrame': 'Day 1 and Day 15'}], 'secondaryOutcomes': [{'measure': 'Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 1 Hour of Infusion Completion', 'timeFrame': 'Within 1 hour of infusion completion', 'description': 'Number of infusions with temporally associated AEs with an onset time during or within 1 hour of infusion completion, regardless of causality assessment'}, {'measure': 'Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 24 Hours of Completion of an Infusion', 'timeFrame': 'Within 24 hours of the end of infusion', 'description': 'Number of infusions with temporally associated AEs with an onset time during or within 24 hours of infusion completion, regardless of causality assessment'}, {'measure': 'Number of Infusions With Temporally Associated Adverse Events (AEs) That Began During or Within 72 Hours of Completion of an Infusion', 'timeFrame': 'Within 72 hours of the end of infusion', 'description': 'Number of infusions with temporally associated AEs with an onset time during or within 72 hours of infusion completion, regardless of causality assessment'}, {'measure': 'Number of Possibly or Probably Related Adverse Events (AEs) That Began During an Infusion', 'timeFrame': 'Day 1 and Day 15', 'description': 'Number of AEs that occurred during an infusion and were deemed related to study product administration'}, {'measure': 'Number of Possibly or Probably Related Adverse Events That Occurred Between 72 Hours and 14 Days After Infusion', 'timeFrame': '72 hours post infusion to 14 days post infusion', 'description': 'Number of AEs that occurred between 72 hours and 14 day following an infusion and were deemed related to study product administration'}, {'measure': 'Number of Participants Testing Positive for Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Parvovirus B19 (PVB19) or Human Immunodeficiency Virus (HIV) Following Treatment With GLASSIA', 'timeFrame': '105 days', 'description': 'Number of participants with seroconversion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['for this study', 'volunteers', 'Focus', 'Condition:'], 'conditions': ['Alpha1-antitrypsin Deficiency', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to generate sufficient safety and tolerability information in support of an increase in the infusion rate of intravenous GLASSIA in the prescribing information from 0.04 to 0.2 mL/kg/min.', 'detailedDescription': 'To achieve proper masking, 30 participants were randomly assigned to receive either GLASSIA at 0.04 mL/kg/min with a simultaneous administration of placebo (2.5% human albumin in normal saline) at 0.2 mL/kg/min (Cohort 1) or GLASSIA at 0.2 mL/kg/min with a simultaneous administration of placebo at 0.04 mL/kg/min (Cohort 2) on Day 1.\n\nTwo weeks later (Day 15), the same participants received the second infusion with the opposite rate of GLASSIA infusion and the corresponding masking placebo infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, 18 to 65 years of age inclusive, at the time of screening\n* Body mass index (BMI) in the range of 19.0 to 32.0 kg/m2 (inclusive) and body weight \\>= 50 kg at the time of screening\n* Healthy subject with no clinical evidence of acute and/or chronic disease and no clinically significant abnormalities on hematology panel, clinical chemistry panel, urinalysis, or electrocardiogram (ECG) at the time of screening\n* Negative drug screen test at screening. Subject must agree to refrain from heavy alcohol consumption (defined as more than 2 drinks per day on a regular basis) and use of narcotic drugs or illegal substances for at least 2 weeks prior to screening and throughout the course of the study. Subject must also agree to drug screen testing at the discretion of the investigator at any time during the course of the study.\n* If female of childbearing potential, subject presents with a negative serum pregnancy test and agrees to employ adequate birth control measures for the duration of the study\n* If male, the subject must agree to use an acceptable form of birth control throughout the study and for at least 90 days after dosing. Additionally, the subject must agree to abstain from sperm donation for 90 days after the last administration of investigational product.\n* Subject is willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* Known history of OR positive serological evidence at the time of screening for hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), Parvovirus B19 (PVB19) or human immunodeficiency virus (HIV) type 1/2 infection\n* Known history of hypersensitivity or adverse reactions (e.g. urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following administration of blood or blood components\n* Documented immunoglobulin A (IgA) deficiency (\\<7 mg/dL at screening)\n* Evidence of uncontrolled hypertension (systolic blood pressure of \\>160 mm Hg, and/or diastolic blood pressure of \\>100 mm Hg despite anti-hypertensive medications)\n* Subject is nursing or intends to begin nursing during the course of the study\n* Subject has participated in a clinical trial and has received an investigational product within 60 days prior to screening\n* Subject has a planned medical procedure within the study period\n* Any clinically significant medical, psychiatric, or cognitive illness or recreational drug/alcohol use that, in the opinion of the investigator, may impede the subject's ability to comply with the study procedures, pose increased risk to the subject's safety, or confound the interpretation of study results"}, 'identificationModule': {'nctId': 'NCT01651351', 'briefTitle': 'GLASSIA Infusion Rate Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': '471201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Day 1:\n\n* GLASSIA at 0.04 mL/kg/min\n* Placebo at 0.2 mL/kg/min\n\nDay 15:\n\n* GLASSIA at 0.2 mL/kg/min\n* Placebo at 0.04 mL/kg/min', 'interventionNames': ['Biological: Alpha1-proteinase inhibitor', 'Biological: Placebo: Human albumin 2.5%']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Day 1:\n\n* GLASSIA at 0.2 mL/kg/min\n* Placebo at 0.04 mL/kg/min\n\nDay 15:\n\n* GLASSIA at 0.04 mL/kg/min\n* Placebo at 0.2 mL/kg/min', 'interventionNames': ['Biological: Alpha1-proteinase inhibitor', 'Biological: Placebo: Human albumin 2.5%']}], 'interventions': [{'name': 'Alpha1-proteinase inhibitor', 'type': 'BIOLOGICAL', 'otherNames': ['GLASSIA'], 'description': 'GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'Placebo: Human albumin 2.5%', 'type': 'BIOLOGICAL', 'description': 'Intravenous administration', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}