Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-02 @ 5:42 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:
Infant Bacterial Therapeutics
Organization:
Study Overview
Official Title:
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.
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: