Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-25 @ 12:37 PM
Study NCT ID:
NCT01063595
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2010-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.eppolito@octapharma.com', 'phone': '201 604-1155', 'title': 'Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine', 'organization': 'Octapharma USA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Safety population: All participants who received at least 1 of the study treatments in any study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Octaplas LG', 'description': 'Participants received 1200 mL of Octaplas LG intravenously once.', 'otherNumAtRisk': 60, 'otherNumAffected': 34, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Octaplas SD', 'description': 'Participants received 1200 mL of Octaplas SD intravenously once.', 'otherNumAtRisk': 60, 'otherNumAffected': 39, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 9}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octaplas LG', 'description': 'Participants received 1200 mL of Octaplas LG intravenously once.'}, {'id': 'OG001', 'title': 'Octaplas SD', 'description': 'Participants received 1200 mL of Octaplas SD intravenously once.'}], 'classes': [{'title': 'Factor I', 'categories': [{'measurements': [{'value': '8.11', 'spread': '8.93', 'groupId': 'OG000'}, {'value': '9.12', 'spread': '8.75', 'groupId': 'OG001'}]}]}, {'title': 'Factor II', 'categories': [{'measurements': [{'value': '7.08', 'spread': '6.46', 'groupId': 'OG000'}, {'value': '6.68', 'spread': '7.35', 'groupId': 'OG001'}]}]}, {'title': 'Factor V', 'categories': [{'measurements': [{'value': '6.31', 'spread': '9.35', 'groupId': 'OG000'}, {'value': '6.91', 'spread': '10.09', 'groupId': 'OG001'}]}]}, {'title': 'Factor VII', 'categories': [{'measurements': [{'value': '8.48', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '9.28', 'spread': '14.53', 'groupId': 'OG001'}]}]}, {'title': 'Factor VIII', 'categories': [{'measurements': [{'value': '1.50', 'spread': '9.38', 'groupId': 'OG000'}, {'value': '5.21', 'spread': '9.93', 'groupId': 'OG001'}]}]}, {'title': 'Factor IX', 'categories': [{'measurements': [{'value': '8.86', 'spread': '9.11', 'groupId': 'OG000'}, {'value': '11.08', 'spread': '7.74', 'groupId': 'OG001'}]}]}, {'title': 'Factor X', 'categories': [{'measurements': [{'value': '7.90', 'spread': '8.96', 'groupId': 'OG000'}, {'value': '9.97', 'spread': '12.37', 'groupId': 'OG001'}]}]}, {'title': 'Factor XI', 'categories': [{'measurements': [{'value': '6.53', 'spread': '6.32', 'groupId': 'OG000'}, {'value': '8.24', 'spread': '7.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration', 'description': 'Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.'}, {'type': 'PRIMARY', 'title': 'Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octaplas LG', 'description': 'Participants received 1200 mL of Octaplas LG intravenously once.'}, {'id': 'OG001', 'title': 'Octaplas SD', 'description': 'Participants received 1200 mL of Octaplas SD intravenously once.'}], 'classes': [{'title': 'Prothrombin time', 'categories': [{'measurements': [{'value': '1.36', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '6.18', 'groupId': 'OG001'}]}]}, {'title': 'Activated partial thromboplastin time', 'categories': [{'measurements': [{'value': '-4.60', 'spread': '3.71', 'groupId': 'OG000'}, {'value': '-5.73', 'spread': '4.39', 'groupId': 'OG001'}]}]}, {'title': 'Protein C', 'categories': [{'measurements': [{'value': '9.49', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '9.75', 'spread': '6.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration', 'description': 'Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.'}, {'type': 'SECONDARY', 'title': 'Concentration of Plasmin Inhibitor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Octaplas LG', 'description': 'Participants received 1200 mL of Octaplas LG intravenously once.'}, {'id': 'OG001', 'title': 'Octaplas SD', 'description': 'Participants received 1200 mL of Octaplas SD intravenously once.'}], 'classes': [{'title': 'Pre-plasmapheresis 30 minutes', 'categories': [{'measurements': [{'value': '90.51', 'spread': '9.93', 'groupId': 'OG000'}, {'value': '91.53', 'spread': '9.12', 'groupId': 'OG001'}]}]}, {'title': 'Post-plasmapheresis 5 minutes', 'categories': [{'measurements': [{'value': '85.72', 'spread': '9.34', 'groupId': 'OG000'}, {'value': '85.67', 'spread': '10.08', 'groupId': 'OG001'}]}]}, {'title': 'Post-transfusion 15 minutes', 'categories': [{'measurements': [{'value': '79.81', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '74.93', 'spread': '8.72', 'groupId': 'OG001'}]}]}, {'title': 'Post-transfusion 2 hours', 'categories': [{'measurements': [{'value': '79.21', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '75.23', 'spread': '9.11', 'groupId': 'OG001'}]}]}, {'title': 'Post-plasmapheresis 24 hours', 'categories': [{'measurements': [{'value': '88.35', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '85.40', 'spread': '8.93', 'groupId': 'OG001'}]}]}, {'title': 'Post-plasmapheresis 7 days', 'categories': [{'measurements': [{'value': '90.95', 'spread': '9.79', 'groupId': 'OG000'}, {'value': '91.65', 'spread': '9.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis', 'description': 'Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.', 'unitOfMeasure': 'Percentage inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population: All participants who had evaluable efficacy measurements in both of the treatment periods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Octaplas SD First, Then Octaplas LG', 'description': 'Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.'}, {'id': 'FG001', 'title': 'Octaplas LG First, Then Octaplas SD', 'description': 'Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.'}], 'periods': [{'title': 'Enrolled in Study and Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawn by the Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.6', 'spread': '9.11', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population: All participants who received at least 1 of the study treatments in any study period.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-12', 'studyFirstSubmitDate': '2010-02-04', 'resultsFirstSubmitDate': '2014-03-31', 'studyFirstSubmitQcDate': '2010-02-04', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-31', 'studyFirstPostDateStruct': {'date': '2010-02-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI', 'timeFrame': 'From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration', 'description': 'Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.'}, {'measure': 'Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C', 'timeFrame': 'From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration', 'description': 'Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.'}], 'secondaryOutcomes': [{'measure': 'Concentration of Plasmin Inhibitor', 'timeFrame': 'From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis', 'description': 'Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.'}]}, 'conditionsModule': {'keywords': ['Octaplas LG', 'Octaplas SD'], 'conditions': ['Comparison of Octaplas LG and Octaplas SD']}, 'referencesModule': {'references': [{'pmid': '23320451', 'type': 'DERIVED', 'citation': 'Jilma-Stohlawetz P, Kursten FW, Horvath M, Leitner G, List J, Marcek J, Quehenberger P, Schwameis M, Bartko J, Derhaschnig U, Jilma B. Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion. 2013 Sep;53(9):1906-17. doi: 10.1111/trf.12075. Epub 2013 Jan 16.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Capable of understanding and complying with all aspects of the protocol.\n* Signed Informed Consent.\n* Capable of understanding the plasmapheresis information sheet and sign it.\n* Healthy male or female volunteers, age 18 years or older.\n* Women must have negative pregnancy test (human chorionic gonadotropin \\[HCG\\] based assay).\n* Women must have sufficient methods of contraception (eg, intrauterine device, oral contraception, etc).\n* No clinically relevant abnormalities in medical history and general physical examination.\n* Standard health insurance.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Tattoos within the last 3 months.\n* Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived products within the last 6 months.\n* Hypersensitivity to blood products or plasma proteins.\n* History of angioedema.\n* History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis, or platelet function.\n* Any clinically significant abnormal laboratory values.\n* IgA deficiency.\n* Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus type 1 or type 2 antibodies.\n* Symptoms of a clinically relevant illness within 3 weeks before the first trial day.\n* History of or suspected drug or alcohol abuse.\n* Subjects currently participating in another clinical study.\n* Any investigational medicinal product administration within the last 4 weeks.'}, 'identificationModule': {'nctId': 'NCT01063595', 'briefTitle': 'A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Octapharma'}, 'officialTitle': 'A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®', 'orgStudyIdInfo': {'id': 'LAS-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Octaplas LG', 'description': 'Participants received 1200 mL of Octaplas LG intravenously once.', 'interventionNames': ['Biological: Octaplas LG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Octaplas SD', 'description': 'Participants received 1200 mL of Octaplas SD intravenously once.', 'interventionNames': ['Biological: Octaplas SD']}], 'interventions': [{'name': 'Octaplas LG', 'type': 'BIOLOGICAL', 'description': 'Octaplas LG was composed of human coagulation-active plasma treated with solvent/detergent for 1-1.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. An additional manufacturing step, involving an affinity ligand gel, removed prion proteins. Octaplas LG was provided frozen in pyrogen free plastic bags.', 'armGroupLabels': ['Octaplas LG']}, {'name': 'Octaplas SD', 'type': 'BIOLOGICAL', 'description': 'Octaplas SD was composed of human coagulation-active plasma treated with solvent/detergent for 4-4.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. Octaplas SD was provided frozen in pyrogen free plastic bags.', 'armGroupLabels': ['Octaplas SD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'country': 'Austria', 'facility': 'Department of Clinical Pharmacology - Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Octapharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}