A Clinical Efficacy and Safety Study of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03253263 |
Recruitment Status :
Active, not recruiting
First Posted : August 17, 2017
Last Update Posted : December 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP) | Drug: OHB-607 | Phase 2 |
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 |
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Experimental: OHB-607
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
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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.
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- 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
- 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
- Incidence and severity of BPD [ Time Frame: Baseline through 36 weeks postmenstrual age (PMA) ]BPD severity is defined by the modified NICHD severity grading
- Incidence and severity of IVH [ Time Frame: Baseline through 36 weeks postmenstrual age (PMA) ]IVH grade as classified according to the Volpe criteria
- Neurodevelopment outcomes [ Time Frame: From 6 months CA through 24 months CA ]Neurodevelopmental impairment, Physical and cognitive development will be measured by standardised questionnaires
- Incidence of Retinopathy of Prematurity (ROP) [ Time Frame: Baseline through 40 weeks PMA ]ROP is classified according to the International Classification
- 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
- Exposure-response Pharmacokinetics/Pharmacodynamics relationships [ Time Frame: Baseline through 40 weeks PMA ]Relationship between IGF-1 exposure and study endpoints

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

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

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. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 |