Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 10:00 AM
Study NCT ID:
NCT02202356
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2014-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ALS-008176 in Infants Hospitalized With RSV
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': 'C000597470', 'term': "4'-chloromethyl-2'-deoxy-3',5'-di-O-isobutyryl-2'-fluorocytidine"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2014-07-23', 'studyFirstSubmitQcDate': '2014-07-24', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': 'Physical Examinations', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': 'Vital Signs', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': '12-Lead ECGs', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': 'Clinical Laboratory Results', 'timeFrame': 'Baseline through 6 days post-dose'}], 'secondaryOutcomes': [{'measure': 'RSV viral RNA concentrations in nasal aspirates', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': 'Emergence of resistance', 'timeFrame': 'Baseline through 6 days post-dose', 'description': 'Changes in RSV polymerase that result in reduced sensitivity to study drug'}, {'measure': 'Pharmacokinetic parameters, including maximum and minimum drug concentrations', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': 'Pharmacokinetic parameters, including time to maximum concentration and half-life', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': 'Pharmacokinetic parameters, including area under concentration-time curves (AUCs)', 'timeFrame': 'Baseline through 6 days post-dose'}, {'measure': 'Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)', 'timeFrame': 'Baseline through 6 days post-dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['RSV', 'Respiratory Syncytial Virus'], 'conditions': ['Respiratory Syncytial Virus Infections']}, 'referencesModule': {'references': [{'pmid': '37467213', 'type': 'DERIVED', 'citation': 'Oey A, McClure M, Symons JA, Chanda S, Fry J, Smith PF, Luciani K, Fayon M, Chokephaibulkit K, Uppala R, Bernatoniene J, Furuno K, Stanley T, Huntjens D, Witek J; 503 and RSV2004 Study Groups. Lumicitabine, an orally administered nucleoside analog, in infants hospitalized with respiratory syncytial virus (RSV) infection: Safety, efficacy, and pharmacokinetic results. PLoS One. 2023 Jul 19;18(7):e0288271. doi: 10.1371/journal.pone.0288271. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or \\<28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness\n\nExclusion Criteria:\n\n* Prematurity\n* Receiving invasive endotracheal mechanical ventilation\n* Poorly functioning gastrointestinal tract\n* Anticipated to be discharged from the hospital in \\<24 hours from the time of randomization\n* Prior exposure to palivizumab'}, 'identificationModule': {'nctId': 'NCT02202356', 'briefTitle': 'A Study of ALS-008176 in Infants Hospitalized With RSV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alios Biopharma Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection', 'orgStudyIdInfo': {'id': 'ALS-8176-503'}, 'secondaryIdInfos': [{'id': '2013-005104-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALS-008176 Single Dose', 'description': 'Single dose of ALS-008176 administered orally as a suspension', 'interventionNames': ['Drug: ALS-008176']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Single Dose', 'description': 'Single dose of placebo administered orally as a suspension', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ALS-008176 Multiple Doses', 'description': 'Multiple doses of ALS-008176 administered orally as a suspension', 'interventionNames': ['Drug: ALS-008176']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Multiple Doses', 'description': 'Multiple doses of placebo administered orally as a suspension', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALS-008176', 'type': 'DRUG', 'armGroupLabels': ['ALS-008176 Multiple Doses', 'ALS-008176 Single Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo Multiple Doses', 'Placebo Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'The University of California at San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Sciences Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "The Children's Mercy", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '14611', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "The Research Institute at Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Children's Hospital/University of Tennessee", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital/Baylor College of Medicine", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Canberra', 'country': 'Australia', 'facility': 'The Canberra Hospital', 'geoPoint': {'lat': -35.28346, 'lon': 149.12807}}, {'city': 'Melbourne', 'country': 'Australia', 'facility': 'Monash Medical Center', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'North Adelaide', 'country': 'Australia', 'facility': "Women's and Children's Hospital", 'geoPoint': {'lat': -34.90733, 'lon': 138.59141}}, {'city': 'Parkville', 'country': 'Australia', 'facility': "The Royal Children's Hospital Melbourne", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Perth', 'country': 'Australia', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': "The Children's Hospital Research Institute of Manitoba", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Canadian Centre for Vaccinology IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "McMaster Children's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'San Miguel', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Hospital Dr. Exequiel Gonzalez Cortes', 'geoPoint': {'lat': -33.49168, 'lon': -70.65709}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Complejo Asistencial Dr Sotero del Rio', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Padre Hurtado', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Bogotá', 'country': 'Colombia', 'facility': 'Fundacion Cardio Infantil Instituto de Cardiologia', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Medellín', 'country': 'Colombia', 'facility': 'Hospital Pablo Tobon Uribe', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin / Pneumologie pediatrique', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Paris', 'country': 'France', 'facility': 'Hopital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Hirosaki-shi', 'state': 'Aomori', 'country': 'Japan', 'facility': 'Hirosaki National Hospital'}, {'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': "Chiba Children's Hospital", 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Asahikawa-Kosei General Hospital'}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'facility': 'NHO Kanazawa Medical Center', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Takamatsu', 'state': 'Kagawa-ken', 'country': 'Japan', 'facility': 'NHO Shikoku Medical Center for Children and Adults', 'geoPoint': {'lat': 34.33333, 'lon': 134.05}}, {'city': 'Urumi', 'state': 'Okinawa', 'country': 'Japan', 'facility': 'Okinawa Chubu Hospital'}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': "Nakano Children's Hospital", 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '351-0102', 'city': 'Wako', 'state': 'Saitama', 'country': 'Japan', 'facility': 'National Hospital Organization Saitama National Hospital', 'geoPoint': {'lat': 35.78944, 'lon': 139.62333}}, {'city': 'Fuchu-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': "Tokyo Metropolitan Children's Medical Center"}, {'city': 'Setagaya-ku', 'state': 'Tokyo', 'country': 'Japan', 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'Tygerberg Academic Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Linkou Chang Gung Medical Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'MacKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Chulalongkorn University Department of Pediatrics', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Phramongkutklao Hospital Department of Pediatrics', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital, Mahidol University Department of Pediatrics', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Khon Kaen University Department of Pediatrics', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'city': 'Bristol', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Bristol Royal Hospital for Children', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': "Alder Hey Children's Hospital", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. George's University of London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University Hospital Southampton NHS Foundation Trust', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Sick Children', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': "Children's Hospital of Wales", 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Brighton', 'country': 'United Kingdom', 'facility': "Royal Alexandra Children's Hospital", 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': "Royal Manchester Children's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Queens Medical Center', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'University of Oxford', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Matthew McClure, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alios BioPharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alios Biopharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}