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NCT Number: NCT03253263

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

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.

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Key information

Conditions

Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Intraventricular Hemorrhage Lung Diseases Lung Injury Respiratory Tract Diseases Retinal Diseases Retinopathy of Prematurity Retinopathy of Prematurity (ROP) Ventilator-Induced Lung Injury

Age range

0 hour–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Hospital for Women, Randwick, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OHB-607

Drug

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

Other names: Mecasermin Rinfabate

Primary outcomes

  1. 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

  1. 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.

    Time frame: Baseline through 12 months CA

    The final weaning off of RTS is defined as the 7th consecutive day that the subject is off RTS.

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

    Severe BPD is defined based on the classification according to Jensen et al., 2019

  3. 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

    Time frame: Baseline through 40 weeks postmenstrual age (PMA)

    Severe IVH as classified according to the Volpe criteria

  4. 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

    Time frame: Baseline through 40 weeks postmenstrual age (PMA)

  5. 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.

    Time frame: Baseline until 12 months CA using CLDPSS

  6. 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: Time Frame: Determined by the separate BSID III scales at 24 months CA

  7. Chronic respiratory morbidity outcomes at 24 months CA

    Time frame: 24 months CA

  8. Incidence and severity of BPD

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

    BPD severity is defined by the modified NICHD severity grading

  9. 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

    Time frame: 36 weeks weeks postmenstrual age (PMA) (± 3 days)

  10. Incidence and severity of IVH

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

    Incidence of all grades of IVH as assessed by centrally read CUS and classified according to the Volpe criteria

  11. Neurodevelopment outcomes

    Time frame: From 6 months CA through 24 months CA

    Neurodevelopmental impairment, Physical and cognitive development will be measured by ASQ®-3 administered at 12 and 24 months CA.

  12. Incidence of Retinopathy of Prematurity (ROP)

    Time frame: Baseline through 40 weeks PMA

    ROP is classified according to the International Classification

  13. Mortality from randomization through to 24 months CA

    Time frame: From birth through 24 months CA

    Mortality rates from randomization to initial hospital discharge and from initial discharge through 24 months CA.

  14. Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD)

    Time frame: Baseline through 36 weeks PMA

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of BPD

  15. Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH)

    Time frame: Baseline through 40 weeks PMA

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of IVH

  16. Exposure-response relationship between measured IGF-1 and necrotizing enterocolitis (NEC)

    Time frame: Baseline through 40 weeks PMA

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of NEC

  17. Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP)

    Time frame: Baseline through 40 weeks PMA

    Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of ROP

  18. To assess the safety profile of OHB-607 as compared to the SNC group.

    Time frame: Baseline through 24 months CA

    Incidence, severity, and causality assessment of Adverse Events (AEs) and Serious Adverse Events (SAEs), including Fatal AEs as per the neonatal adverse event severity scale.

Study contacts

Contact information is provided by the study sponsor or research team.

OHB Contact

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

OHB Neonatology Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Aug 17, 2017
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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