Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-01-05 @ 6:10 PM
Study NCT ID:
NCT03511066
Status:
TERMINATED
Last Update Posted:
2022-10-31
First Post:
2018-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'contact@celltrion.com', 'phone': '82328505000', 'title': 'Clinical Planning Department Leader', 'organization': 'Celltrion'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "All death, 'treatment-emergent' serious adverse events and 'treatment-emergent' adverse events were summarized."}}, 'adverseEventsModule': {'timeFrame': 'up to Day 110/end-of-study (EOS) visit', 'eventGroups': [{'id': 'EG000', 'title': 'CT-P27 90 mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 90 mg/kg: Influenza A treatment drug.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 8, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CT-P27 45mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 45 mg/kg: Influenza A treatment drug.', 'otherNumAtRisk': 90, 'deathsNumAtRisk': 90, 'otherNumAffected': 8, 'seriousNumAtRisk': 90, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo will be administrated once in IV infusion.\n\nPlacebos: Placebo.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 6, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Resolution of Influenza Symptoms and Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P27 90 mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 90 mg/kg: Influenza A treatment drug.'}, {'id': 'OG001', 'title': 'CT-P27 45mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 45 mg/kg: Influenza A treatment drug.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo will be administrated once in IV infusion.\n\nPlacebos: Placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.74', 'groupId': 'OG000', 'lowerLimit': '2.72', 'upperLimit': '4.46'}, {'value': '3.69', 'groupId': 'OG001', 'lowerLimit': '2.81', 'upperLimit': '4.25'}, {'value': '5.72', 'comment': 'The upper limit of 95% CI was not calculated due to insufficient number of participants with events (resolution of influenza symptoms and fever).', 'groupId': 'OG002', 'lowerLimit': '3.65', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Twice a day (Morning and Evening) from Day 1 to Day 8', 'description': 'Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\\<37.8)', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat-infected (ITTI) population defined as all randomized subjects with confirmed influenza A by quantitative polymerase chain reaction (qPCR) or cell culture.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT-P27 90 mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 90 mg/kg: Influenza A treatment drug.'}, {'id': 'FG001', 'title': 'CT-P27 45mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 45 mg/kg: Influenza A treatment drug.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo will be administrated once in IV infusion.\n\nPlacebos: Placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CT-P27 90 mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 90 mg/kg: Influenza A treatment drug.'}, {'id': 'BG001', 'title': 'CT-P27 45mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.\n\nCT-P27 45 mg/kg: Influenza A treatment drug.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo will be administrated once in IV infusion.\n\nPlacebos: Placebo.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '63'}, {'value': '40.0', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '64'}, {'value': '34.5', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '60'}, {'value': '38.0', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '64'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '116', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Positive rapid influenza diagnostic test at screening', 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Influenza A confirmation', 'classes': [{'categories': [{'title': 'by cell culture or qPCR', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}, {'title': 'Not detected', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Influenza A subtype', 'classes': [{'categories': [{'title': 'Influenza A/H1', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Influenza A/H3', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not applicable', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Total influenza symptom score at screening', 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'groupId': 'BG000', 'lowerLimit': '1.0', 'upperLimit': '3.0'}, {'value': '2.05', 'groupId': 'BG001', 'lowerLimit': '0.8', 'upperLimit': '3.0'}, {'value': '2.12', 'groupId': 'BG002', 'lowerLimit': '0.8', 'upperLimit': '3.0'}, {'value': '2.08', 'groupId': 'BG003', 'lowerLimit': '0.8', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEAN', 'description': 'Average score of symptoms (Cough, Sore throat, Headache, Nasal congestion, Feeling feverish, Body aches and pains, Fatigue \\[Tiredness\\], Neck pain, Interrupted sleep and Loss of appetite) by Influenza Intensity and Impact Questionnaire (FluiiQ™): 0=None, 1=Mild, 2=Moderate, 3=Severe', 'unitOfMeasure': "Averaged for each symptoms' score", 'dispersionType': 'FULL_RANGE'}, {'title': 'Body temperature at screening', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '0.74', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '0.81', 'groupId': 'BG001'}, {'value': '38.1', 'spread': '0.65', 'groupId': 'BG002'}, {'value': '38.2', 'spread': '0.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '°C', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-31', 'size': 5512773, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-27T20:13', 'hasProtocol': True}, {'date': '2018-10-31', 'size': 5614434, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-27T20:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 228}}, 'statusModule': {'whyStopped': 'CT-P27 2.2 is inactivated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2018-02-28', 'resultsFirstSubmitDate': '2020-02-28', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-28', 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Resolution of Influenza Symptoms and Fever', 'timeFrame': 'Twice a day (Morning and Evening) from Day 1 to Day 8', 'description': 'Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\\<37.8)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['efficacy', 'safety'], 'conditions': ['Influenza A']}, 'descriptionModule': {'briefSummary': 'This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.', 'detailedDescription': 'This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female subjects between the ages of 19 and 64 years, both inclusive\n* Diagnosed with influenza A at screening using rapid influenza diagnostic test\n* Onset of influenza symptoms and fever is within 48 hours at screening\n* At least 2 of symptoms (moderate to severe in intensity)\n* ≥38.0'C body temperature at screening\n\nExclusion Criteria:\n\n* Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug\n* Positive influenza B or A+B infection"}, 'identificationModule': {'nctId': 'NCT03511066', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection', 'orgStudyIdInfo': {'id': 'CT-P27 2.2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P27 90 mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.', 'interventionNames': ['Drug: CT-P27 90 mg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'CT-P27 45mg/kg', 'description': 'CT-P27 will be administrated once in IV infusion.', 'interventionNames': ['Drug: CT-P27 45 mg/kg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be administrated once in IV infusion.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CT-P27 90 mg/kg', 'type': 'DRUG', 'otherNames': ['CT-P27'], 'description': 'Influenza A treatment drug.', 'armGroupLabels': ['CT-P27 90 mg/kg']}, {'name': 'CT-P27 45 mg/kg', 'type': 'DRUG', 'otherNames': ['CT-P27'], 'description': 'Influenza A treatment drug.', 'armGroupLabels': ['CT-P27 45mg/kg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'MoonSun Choi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celltrion Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}