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

OHB Neonatology Ltd.125 sites in 11 countries338 target enrollmentMay 9, 2019

ConditionsBronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP)

InterventionsOHB-607

DrugsOHB-607

Overview

Phase: Phase 2
Intervention: OHB-607
Conditions: Bronchopulmonary Dysplasia
Sponsor: OHB Neonatology Ltd.
Enrollment: 338
Locations: 125
Primary Endpoint: 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.
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 9, 2019

End Date

January 21, 2028

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OHB Neonatology Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consents and/or assents must be signed and dated by the participant's parent(s) prior to any study related procedures. The informed consent and any assents for underage parents must be approved by the IRB/IEC (in accordance with local regulations).
•Written informed consents and/or assents must be signed and dated by the participant's birth mother prior to providing study-related information related to birth mother medical history, pregnancy and the birth of the participant. The informed consent and any assents for underage birth mothers must be approved by the IRB/IEC (in accordance with local regulations).
•Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

Exclusion Criteria

•Detectable major (or severe) congenital malformation identified before randomization.
•Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
•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.
•Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
•Any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participant's potential compliance with this protocol or interfere with interpretation of results.
•Current or planned participation in a clinical study of another investigational study treatment, device, or procedure (participation in non-interventional studies is permitted on a case-by-case basis).
•The participant or participant's parent(s) is/are unable to comply with the protocol or is unlikely to be available for long-term follow-up as determined by the investigator.
•Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.
•Birth mother with known HIV or hepatitis (B, C, or E) infection.

Arms & Interventions

OHB-607

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

Intervention: OHB-607

Standard Neonatal Care

Standard neonatal care alone will be provided.

Outcomes

Primary Outcomes

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.

Time Frame: Baseline through 36 weeks postmenstrual age (PMA)

Severe BPD is defined by the modified NICHD severity grading

Secondary Outcomes

Chronic respiratory morbidity outcomes at 24 months CA(24 months CA)
Incidence and severity of BPD(Baseline through 36 weeks postmenstrual age (PMA))
Neurodevelopment outcomes(From 6 months CA through 24 months CA)
To assess the effect of OHB-607 on chronic respiratory outcomes as measured by the Chronic Lung Disease Prematurity Severity Score (CLDPSS) as compared to the SNC group at 12 months CA.(Baseline until 12 months CA using CLDPSS)
Incidence and severity of IVH(Baseline through 36 weeks postmenstrual age (PMA))
Mortality from randomization through to 24 months CA(From birth through 24 months CA)
Jensen BPD grade at 36 weeks PMA (± 3 days), as classified according to Jensen et al., 2019. Incidence of all severity grades of BPD as assessed by Jensen et al., 2019(36 weeks weeks postmenstrual age (PMA) (± 3 days))
Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP)(Baseline through 40 weeks PMA)
Incidence of Retinopathy of Prematurity (ROP)(Baseline through 40 weeks PMA)
Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD)(Baseline through 36 weeks PMA)
Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH)(Baseline through 40 weeks PMA)
Reducing the burden of Chronic Lung Disease, as indicated by a reduction in time to final weaning off of Respiratory Technology Support (RTS) through 12 months Corrected Age (CA), as compared to the SNC group.(Baseline through 12 months CA)
Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death at or before 36 weeks PMA, whichever comes first as compared to the SNC group.(Time Frame: Baseline through 36 weeks postmenstrual age (PMA))
Occurrence of severe (Grade 3 and 4) intraventricular hemorrhage (IVH) before 40 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group(Baseline through 40 weeks postmenstrual age (PMA))
To assess the effect of OHB-607 on occurrence of severe retinopathy of prematurity (ROP) (Stage 3 and above) up to 40 weeks PMA as compared to the SNC group(Baseline through 40 weeks postmenstrual age (PMA))
The effect of OHB-607 on neurodevelopment is measured by the Cognitive, Language and Motor Scales of the Bayley Scales of Infant and Toddler Development (BSID) III as compared to the SNC group at 24 months CA.(Time Frame: Determined by the separate BSID III scales at 24 months CA)
Exposure-response relationship between measured IGF-1 and necrotizing enterocolitis (NEC)(Baseline through 40 weeks PMA)
To assess the safety profile of OHB-607 as compared to the SNC group.(Baseline through 24 months CA)