Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04662151
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2020-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1b portion is a randomized, dual-armed, dose escalation study to establish the safest \\& most tolerated AT-100 dose tested as compared to air-sham alone.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-02', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events', 'timeFrame': 'Adverse events will be followed up to Day 28 of life', 'description': 'Incidence and severity of adverse events between the two treatment groups will be compared'}, {'measure': 'Incidence of BPD or death', 'timeFrame': 'Week 36 PMA'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bronchopulmonary Dysplasia', 'Preterm', 'Neonate', 'Mechanical ventilation', 'Respiratory support', 'recombinant human Surfactant Protein-D (rhSP-D)', 'intratracheal', 'air-sham'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '31727986', 'type': 'BACKGROUND', 'citation': 'Thebaud B, Goss KN, Laughon M, Whitsett JA, Abman SH, Steinhorn RH, Aschner JL, Davis PG, McGrath-Morrow SA, Soll RF, Jobe AH. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78. doi: 10.1038/s41572-019-0127-7.'}, {'pmid': '30995069', 'type': 'BACKGROUND', 'citation': 'Jensen EA, Dysart K, Gantz MG, McDonald S, Bamat NA, Keszler M, Kirpalani H, Laughon MM, Poindexter BB, Duncan AF, Yoder BA, Eichenwald EC, DeMauro SB. The Diagnosis of Bronchopulmonary Dysplasia in Very Preterm Infants. An Evidence-based Approach. Am J Respir Crit Care Med. 2019 Sep 15;200(6):751-759. doi: 10.1164/rccm.201812-2348OC.'}, {'pmid': '29473039', 'type': 'BACKGROUND', 'citation': 'Sorensen GL. Surfactant Protein D in Respiratory and Non-Respiratory Diseases. Front Med (Lausanne). 2018 Feb 8;5:18. doi: 10.3389/fmed.2018.00018. eCollection 2018.'}, {'pmid': '20133924', 'type': 'BACKGROUND', 'citation': 'Sato A, Whitsett JA, Scheule RK, Ikegami M. Surfactant protein-d inhibits lung inflammation caused by ventilation in premature newborn lambs. Am J Respir Crit Care Med. 2010 May 15;181(10):1098-105. doi: 10.1164/rccm.200912-1818OC. Epub 2010 Feb 4.'}, {'pmid': '16556693', 'type': 'BACKGROUND', 'citation': 'Ikegami M, Carter K, Bishop K, Yadav A, Masterjohn E, Brondyk W, Scheule RK, Whitsett JA. Intratracheal recombinant surfactant protein d prevents endotoxin shock in the newborn preterm lamb. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1342-7. doi: 10.1164/rccm.200509-1485OC. Epub 2006 Mar 23.'}, {'pmid': '41018057', 'type': 'DERIVED', 'citation': 'Alonso-Ojembarrena A, Poindexter B, Aleem S, Healy H, Aguar-Carrascosa M, Moliner-Calderon E, Serrano-Martin MDM, Arroyo R, Vento M. A phase 1b randomized, multicenter, dose determination trial of zelpultide alfa (recombinant human surfactant protein D) in preterm neonates at high risk of developing bronchopulmonary dysplasia. Front Pediatr. 2025 Sep 12;13:1639573. doi: 10.3389/fped.2025.1639573. eCollection 2025.'}], 'seeAlsoLinks': [{'url': 'http://www.airwaytherapeutics.com', 'label': "Airway Therapeutics' corporate website"}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if an investigational drug, AT-100, can reduce the occurrence of Bronchopulmonary Dysplasia (BPD) in babies born premature, as compared to babies born premature who receive an air-sham alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '96 Hours', 'minimumAge': '0 Minutes', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Preterm neonates born between Gestional Age (GA):\n\n 1. 25 0/7 weeks to 28 6/7 weeks in the initial dose escalation cohorts.\n 2. 23 0/7 weeks to 28 6/7 weeks in the latter cohort.\n2. Intubated and on mechanical ventilation.\n3. Receiving at least 1 dose of standard-of-care-indicated surfactant treatment (Curosurf®) after birth, and able to receive the first dose of AT-100 or air-sham within 96 hours of birth given at any time point after 15 minutes following any of the subject's Curosurf® dose(s).\n4. Parent or legal guardian is able to provide informed consent.\n\nExclusion Criteria:\n\n1. Weight at time of birth \\< 400 g or \\> 1,800 g.\n2. Major apparent congenital abnormalities impacting cardio and pulmonary function.\n3. Active DNR (Do Not Resuscitate) order in place.\n4. Known pulmonary air leaks (e.g. pneumothorax and pneumomediastinum) at the time of AT-100 or air-sham administration.\n5. History of allergy or sensitivity to any surfactant or any component of the Investigational Product (AT-100).\n6. AT-100 or air-sham dosing was set to occur before Data Safety Monitoring Committee recommendation to proceed to the next dose-escalation cohort.\n7. Use of minimally invasive surfactant techniques (e.g., LISA, MIST) or INSURE or if, in the opinion of the care team, the infant is very likely too be extubated shortly after receiving Curosurf®.\n\n a. Subjects extubated and re-intubated after their Curosurf® dose(s) are eligible, so long as the subject meets Inclusion #3.\n8. Birth mother:\n\n 1. Has known active Hepatitis B, C, or E diagnosis.\n 2. Has a known illness or exposure that, in the judgement of the Investigator, is serious enough to induce an immune deficiency such as Human Immunodeficiency Virus (HIV) and/or is receiving chemotherapy.\n 3. Has known active Sexually Transmitted Infection (STI).\n 4. Has known Cytomegalovirus (CMV) active infection.\n 5. Has known history or evidence of alcohol or drug abuse, wit the exception of marijuana/marijuana-based products/THC, based on a positive maternal or infant drug screen as evidenced by the institution's standard-of-care practice.\n9. Concurrent enrollment in an investigational drug, device, or treatment modulation trial that utilizes treatments outside of standard-of-care.\n10. Any condition or situation which, in the Investigator's judgement, puts the mother or the neonate at significant risk, could confound the trial results, or may interfere significantly with the mother's or neonate's participation in the trial.\n11. Symptomatic and confirmed COVID-19 infection of the mother around the time of birth."}, 'identificationModule': {'nctId': 'NCT04662151', 'briefTitle': 'A Clinical Safety Study of AT-100 (rhSP-D) in Preterm Neonates at High Risk for Bronchopulmonary Dysplasia (BPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Airway Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1b, Randomized, Blinded, Dose-Determined Study Evaluating the Safety and Tolerability Profile of Intervention With AT-100 (rhSP-D) in Preterm Neonates at High Risk for the Development of Bronchopulmonary Dysplasia (BPD)', 'orgStudyIdInfo': {'id': 'AT-100/001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b open-label AT-100', 'description': 'Once daily AT-100 via intratracheal administration for up to 2 doses (initial Phase 1b dose-escalation portion) or 7 doses (latter Phase 1b highest tolerated \\& safety dose level tested portion).', 'interventionNames': ['Biological: AT-100']}, {'type': 'SHAM_COMPARATOR', 'label': 'Phase 1b open-label air-sham', 'description': 'Once daily air-sham via intratracheal administration for up to 2 doses (initial Phase 1b dose-escalation portion) or 7 doses (latter Phase 1b highest tolerated \\& safety dose level tested portion).', 'interventionNames': ['Procedure: Air-sham']}], 'interventions': [{'name': 'AT-100', 'type': 'BIOLOGICAL', 'otherNames': ['(rhSP-D)'], 'description': 'reconstituted AT-100 for intratracheal administration', 'armGroupLabels': ['Phase 1b open-label AT-100']}, {'name': 'Air-sham', 'type': 'PROCEDURE', 'description': 'room air for intratracheal administration', 'armGroupLabels': ['Phase 1b open-label air-sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '11009', 'city': 'Cadiz', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'zip': '08041', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28007', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '03010', 'city': 'Alicante', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '46026', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '15006', 'city': 'A Coruña', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Airway Therapeutics Investigational Site', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}], 'overallOfficials': [{'name': 'Marc O. Salzberg, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Airway Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Airway Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}