Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-03 @ 5:56 PM
Study NCT ID:
NCT02309320
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2014-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712591', 'term': 'gontivimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2014-11-27', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination', 'timeFrame': '1 day before first dose to 14 days after first dose'}], 'secondaryOutcomes': [{'measure': 'Clinical activity as measured by the evaluation of the clinical response of the subjects', 'timeFrame': '1 day before first dose to 14 days after first dose'}, {'measure': 'Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum', 'timeFrame': 'Day 3'}, {'measure': 'Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum', 'timeFrame': '1 day before first dose to 14 days after first dose'}, {'measure': 'Immunogenicity as measured by the concentration of anti-drug antibodies in serum', 'timeFrame': '1 day before first dose to 14 days after first dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus Infection']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to investigate the safety and tolerability of ALX-0171.\n\nThe secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '23 Months', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)\n2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV\n3. Subject has a positive RSV diagnostic test\n4. Others as defined in the protocol\n\nExclusion Criteria:\n\n1. Subject has history of wheezing\n2. Subject is known to have significant comorbidities\n3. Subject is known to be immunocompromised\n4. Subject is suspected of having a clinically relevant infection other than RSV\n5. Others as defined in the protocol'}, 'identificationModule': {'nctId': 'NCT02309320', 'briefTitle': 'A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ablynx, a Sanofi company'}, 'officialTitle': 'A Phase I/IIa Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With Respiratory Syncytial Virus Lower Respiratory Tract Infection, Consisting of an Open-label Lead-in Part Followed by a Double-blind, Placebo-controlled Part, to Evaluate the Safety, Tolerability and Clinical Activity of ALX-0171, Administered Via Inhalation, in Addition to Standard of Care.', 'orgStudyIdInfo': {'id': 'ALX0171-C104'}, 'secondaryIdInfos': [{'id': '2014-002841-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALX-0171', 'description': 'Inhalation of ALX-0171 during 3 consecutive days', 'interventionNames': ['Biological: ALX-0171']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Inhalation of Placebo during 3 consecutive days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'ALX-0171', 'type': 'BIOLOGICAL', 'armGroupLabels': ['ALX-0171']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brisbane', 'country': 'Australia', 'facility': 'Investigator Site 4', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '2031', 'city': 'Randwick', 'country': 'Australia', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'city': 'Tasmania', 'country': 'Australia', 'facility': 'Investigator Site 3'}, {'zip': '2145', 'city': 'Westmead', 'country': 'Australia', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Investigator Site 6', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigator Site 4', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Investigator Site 5', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Kozloduy', 'country': 'Bulgaria', 'facility': 'Investigator Site 4', 'geoPoint': {'lat': 43.77691, 'lon': 23.73001}}, {'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'city': 'Sevlievo', 'country': 'Bulgaria', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 43.02295, 'lon': 25.10364}}, {'city': 'Tartu', 'country': 'Estonia', 'facility': 'Investigator Site', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1089', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigators Site 3', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigator Site 4', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Budapest', 'country': 'Hungary', 'facility': 'Investigator Site 5', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Daugavpils', 'country': 'Latvia', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 55.88333, 'lon': 26.53333}}, {'city': 'Riga', 'country': 'Latvia', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Valmiera', 'country': 'Latvia', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'city': 'Ipoh', 'country': 'Malaysia', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 4.5841, 'lon': 101.0829}}, {'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Negeri Sembilan', 'country': 'Malaysia', 'facility': 'Investigator Site 3'}, {'city': 'Pulau Pinang', 'country': 'Malaysia', 'facility': 'Investigator Site 4', 'geoPoint': {'lat': 3.55, 'lon': 102.56667}}, {'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'Investigator Site', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Investigator Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Investigator Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'city': 'Lodz', 'country': 'Poland', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'city': 'Trzebnica', 'country': 'Poland', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 51.31076, 'lon': 17.06331}}, {'zip': '97409', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Investigator Site 5', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '82556', 'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '04011', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'Investigator Site 2', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'city': 'Levice', 'country': 'Slovakia', 'facility': 'Investigator Site 6', 'geoPoint': {'lat': 48.21563, 'lon': 18.60705}}, {'city': 'Liptovský Mikuláš', 'country': 'Slovakia', 'facility': 'Investigator Site 7', 'geoPoint': {'lat': 49.08061, 'lon': 19.62218}}, {'zip': '03659', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Investigator Site 1', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'zip': '05845', 'city': 'Poprad', 'country': 'Slovakia', 'facility': 'Investigator 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51.75222, 'lon': -1.25596}}, {'city': 'Tooting', 'country': 'United Kingdom', 'facility': 'Investigator Site 3', 'geoPoint': {'lat': 51.42524, 'lon': -0.16394}}], 'overallOfficials': [{'name': 'Ablynx Clinical Department', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ablynx, a Sanofi company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ablynx, a Sanofi company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}