Trials / Active Not Recruiting
Active Not RecruitingNCT03978000
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,158 (actual)
- Sponsor
- Infant Bacterial Therapeutics · Industry
- Sex
- All
- Age
- 48 Hours
- Healthy volunteers
- Not accepted
Summary
IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IBP-9414 | Oral suspension |
| DRUG | Placebo | Sterile water |
Timeline
- Start date
- 2019-07-04
- Primary completion
- 2024-06-01
- Completion
- 2024-07-01
- First posted
- 2019-06-06
- Last updated
- 2024-04-12
Locations
89 sites across 10 countries: United States, Bulgaria, France, Hungary, Israel, Poland, Romania, Serbia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03978000. Inclusion in this directory is not an endorsement.