Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT02472769
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2015-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IBP-9414 for the Prevention of Necrotizing Enterocolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-28', 'studyFirstSubmitDate': '2015-06-02', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['Necrotizing Enterocolitis']}, 'descriptionModule': {'briefSummary': 'Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '48 Hours', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Gestational age ≤32 weeks\n2. Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.\n3. \\< 48 hours of age.\n4. Written informed consent from the patient's legally authorized representative(s).\n\nExclusion Criteria:\n\n1. Participation in an additional interventional clinical trial in which an investigational drug will be administered.\n2. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).\n3. Congenital or acquired gastrointestinal pathology.\n4. Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation."}, 'identificationModule': {'nctId': 'NCT02472769', 'briefTitle': 'IBP-9414 for the Prevention of Necrotizing Enterocolitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infant Bacterial Therapeutics'}, 'officialTitle': 'A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.', 'orgStudyIdInfo': {'id': 'IBP-9414-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IBP-9414', 'description': 'IBP-9414 Oral Daily', 'interventionNames': ['Drug: IBP-9414']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Sterile water', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'IBP-9414', 'type': 'DRUG', 'armGroupLabels': ['IBP-9414']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sterile water', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Univ. Arkansas Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32610-0296', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University Florida Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Wolfson Children´s Hospital', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'Memorial Hospital of South Bend', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '67214', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Wesley Medical Center', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Kings County Hospital Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19102', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hahnemann University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Einstein Medical Center of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Jackson Madison County General Hospital', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Timpanogos Regional Hospital', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}], 'overallOfficials': [{'name': 'Josef Neu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida College of Medicine, Gainsville, FL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infant Bacterial Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}