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OHB-607 for Bronchopulmonary Dysplasia

Phase 2
Recruiting
Research Sponsored by Shire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Hypoglycemia at Baseline (blood glucose less than (<) 45 milligrams per deciliter [mg/dL] or 2.5 milli moles per liter [mmol/L]) which persists in spite of glucose supplementation, to exclude severe congenital abnormalities of glucose metabolism.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 6 months ca through 24 months ca
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new medicine to see if it can prevent a serious lung condition in very premature babies. The goal is to see if this new treatment works better at protecting their lungs and reducing the chances of developing chronic lung disease.

Who is the study for?
This trial is for extremely premature infants born between 23 and 27 weeks of gestation. Parents must consent to the study, which excludes infants with significant neurological disease, major congenital malformations, genetic disorders, or those whose mothers had severe COVID-19 during pregnancy.
What is being tested?
The study tests OHB-607's effectiveness in preventing chronic lung disease in extremely premature babies compared to standard care alone. It aims to see if this drug can reduce long-term respiratory issues these infants often face.
What are the potential side effects?
Potential side effects are not specified here but would typically include reactions expected from introducing a new medication into an infant's system such as digestive disturbances or allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood sugar is very low even after taking glucose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 6 months ca through 24 months ca
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 6 months ca through 24 months ca for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction in the incidence of severe Bronchopulmonary Dysplasia (BPD) at 36 weeks (±3 days) Postmenstrual Age (PMA), or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.
Secondary study objectives
Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD)
Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP)
Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH)
+10 more

Side effects data

From 2008 Phase 3 trial • 137 Patients • NCT00125164
24%
Upper respiratory tract infection
16%
Headache
16%
Cough
12%
Otitis media
12%
Sinusitis
8%
Ear pain
8%
Pharyngitis streptococcal
8%
Nasopharyngitis
4%
Pain in extremity
4%
Hypoglycemia
4%
Cellulitis
4%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Untreated
40 μg/kg BID (Twice Daily Dosing)
80 μg/kg BID (Twice Daily Dosing)
120 μg/kg BID (Twice Daily Dosing)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: OHB-607Experimental Treatment1 Intervention
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
Group II: Standard Neonatal CareActive Control1 Intervention
Standard neonatal care alone will be provided.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Bronchopulmonary Dysplasia (BPD) include corticosteroids and surfactant therapy. Corticosteroids work by reducing inflammation in the lungs, which is critical for improving lung function and reducing the need for mechanical ventilation. Surfactant therapy helps to keep the airways open by reducing surface tension, which is essential for preventing lung collapse and improving oxygenation. The investigational drug being studied aims to prevent BPD by potentially reducing inflammation or promoting lung development, which is vital for minimizing lung damage and improving long-term respiratory outcomes in extremely premature infants.
Effect of early low-dose hydrocortisone on survival without bronchopulmonary dysplasia in extremely preterm infants (PREMILOC): a double-blind, placebo-controlled, multicentre, randomised trial.

Find a Location

Who is running the clinical trial?

ShireLead Sponsor
456 Previous Clinical Trials
95,692 Total Patients Enrolled
OHB Neonatology Ltd.Lead Sponsor
Oak Hill Bio LtdLead Sponsor
1 Previous Clinical Trials
26 Total Patients Enrolled

Media Library

OHB-607 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03253263 — Phase 2
Pulmonary Hypertension Research Study Groups: OHB-607, Standard Neonatal Care
Pulmonary Hypertension Clinical Trial 2023: OHB-607 Highlights & Side Effects. Trial Name: NCT03253263 — Phase 2
OHB-607 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03253263 — Phase 2
~59 spots leftby Jan 2026