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Trial record 1 of 2 for:    NCT03253263
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A Clinical Efficacy and Safety Study of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants

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ClinicalTrials.gov Identifier: NCT03253263
Recruitment Status : Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : December 12, 2022
Sponsor:
Information provided by (Responsible Party):
Oak Hill Bio Ltd ( OHB Neonatology Ltd. )

Brief Summary:
The purpose of this study is to determine if an investigational drug can reduce the burden of chronic lung disease in extremely premature infants, as compared to extremely premature infants receiving standard neonatal care alone.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP) Drug: OHB-607 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants Compared to Standard Neonatal Care
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : August 28, 2026
Estimated Study Completion Date : November 28, 2026


Arm Intervention/treatment
Experimental: OHB-607
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
Drug: OHB-607
Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
Other Name: Mecasermin Rinfabate

No Intervention: Standard Neonatal Care
Standard neonatal care alone will be provided.



Primary Outcome Measures :
  1. Reduction in the incidence of severe BPD at 36 weeks (±3 days) PMA, or death, 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 Outcome Measures :
  1. Occurrence of severe (Grade 3 and 4) IVH at 36 weeks PMA, as assessed by cranial ultrasound as compared to the SNC group [ Time Frame: Baseline through 36 weeks postmenstrual age (PMA) ]
    Severe IVH as classified according to the Volpe criteria

  2. Incidence and severity of BPD [ Time Frame: Baseline through 36 weeks postmenstrual age (PMA) ]
    BPD severity is defined by the modified NICHD severity grading

  3. Incidence and severity of IVH [ Time Frame: Baseline through 36 weeks postmenstrual age (PMA) ]
    IVH grade as classified according to the Volpe criteria

  4. Neurodevelopment outcomes [ Time Frame: From 6 months CA through 24 months CA ]
    Neurodevelopmental impairment, Physical and cognitive development will be measured by standardised questionnaires

  5. Incidence of Retinopathy of Prematurity (ROP) [ Time Frame: Baseline through 40 weeks PMA ]
    ROP is classified according to the International Classification

  6. Mortality from birth through to 24 months CA [ Time Frame: From birth through 24 months CA ]
    Mortality rates from >12 hours after birth through 24 months CA

  7. Exposure-response Pharmacokinetics/Pharmacodynamics relationships [ Time Frame: Baseline through 40 weeks PMA ]
    Relationship between IGF-1 exposure and study endpoints



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Hours to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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).
  2. 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).
  3. Subjects must be between 23 weeks +0 days and 27 weeks +6 days GA, inclusive.

Exclusion Criteria:

  1. Detectable major (or severe) congenital malformation identified before randomization.
  2. Known or suspected chromosomal abnormality, genetic disorder, or syndrome, identified before randomization, according to the investigator's opinion.
  3. 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.
  4. Clinically significant neurological disease identified before randomization according to cranial ultrasound (hemorrhages confined to the germinal matrix are allowed) and investigator's opinion.
  5. 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.
  6. 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).
  7. 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.
  8. Birth mother with active COVID-19 infection at birth or a history of severe COVID-19 infection (requiring intensive care hospitalization) during pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03253263


Locations
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Sponsors and Collaborators
OHB Neonatology Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: OHB Neonatology Ltd.
ClinicalTrials.gov Identifier: NCT03253263    
Other Study ID Numbers: OHB-607-202
2018-001393-16 ( EudraCT Number )
jRCT2071200076 ( Registry Identifier: jRCT )
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified individual participant data from this particular study will not be shared in order to minimize the risk that individual patients could be re-identified, given that there are limited numbers of study participants at each study site per year.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Premature Birth
Hemorrhage
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Respiratory Tract Diseases
Retinal Diseases
Eye Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Mecasermin
Growth Substances
Physiological Effects of Drugs