Trials / Recruiting
RecruitingNCT03253263
A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 338 (estimated)
- Sponsor
- OHB Neonatology Ltd. · Industry
- Sex
- All
- Age
- 0 Hours – 24 Hours
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if an investigational drug can prevent Bronchopulmonary Dysplasia, reducing the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.
Conditions
- Bronchopulmonary Dysplasia
- Chronic Lung Disease of Prematurity
- Intraventricular Hemorrhage
- Retinopathy of Prematurity (ROP)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OHB-607 | Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days. |
Timeline
- Start date
- 2019-05-09
- Primary completion
- 2026-01-23
- Completion
- 2028-01-21
- First posted
- 2017-08-17
- Last updated
- 2026-01-07
Locations
66 sites across 14 countries: United States, Australia, Canada, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Portugal, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03253263. Inclusion in this directory is not an endorsement.