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A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

NCT03253263 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2026-01-07

No results posted yet for this study

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

DRUG

OHB-607

Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.

Sponsors & Collaborators

  • OHB Neonatology Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2026-01-23
Completion
2028-01-21
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Finland
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253263 on ClinicalTrials.gov