Trial record 1 of 2 for:
NCT03253263
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
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Sponsor:
OHB Neonatology Ltd.
Information provided by (Responsible Party):
Oak Hill Bio Ltd ( OHB Neonatology Ltd. )
Tracking Information | |||||
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First Submitted Date ICMJE | August 15, 2017 | ||||
First Posted Date ICMJE | August 17, 2017 | ||||
Last Update Posted Date | December 12, 2022 | ||||
Actual Study Start Date ICMJE | May 9, 2019 | ||||
Estimated Primary Completion Date | August 28, 2026 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
Incidence of Chronic Respiratory Morbidity (CRM) Through 12 Months Corrected Age (CA) [ Time Frame: Baseline through 12 Months Corrected Age (CA) ] CRM is a common adverse outcome of premature birth resulting in recurrent respiratory symptoms requiring treatment with pulmonary medications such as bronchodilators, need for supplementary home oxygen, frequent emergency room visits or hospital readmissions, especially during the first year of life. CRM will be measured by respiratory health care utilization and respiratory symptoms.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Clinical Efficacy and Safety Study of OHB-607 in Preventing Chronic Lung Disease in Extremely Premature Infants | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Drug: OHB-607
Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
Other Name: Mecasermin Rinfabate
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Study Arms ICMJE |
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Publications * | Hellstrom W, Hortensius LM, Lofqvist C, Hellgren G, Tataranno ML, Ley D, Benders MJNL, Hellstrom A, Bjorkman-Burtscher IM, Heckemann RA, Savman K. Postnatal serum IGF-1 levels associate with brain volumes at term in extremely preterm infants. Pediatr Res. 2022 Jun 9. doi: 10.1038/s41390-022-02134-4. Online ahead of print. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
338 | ||||
Original Estimated Enrollment ICMJE |
1053 | ||||
Estimated Study Completion Date ICMJE | November 28, 2026 | ||||
Estimated Primary Completion Date | August 28, 2026 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 0 Hours to 24 Hours (Child) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Portugal, Spain, Sweden, United Kingdom, United States | ||||
Removed Location Countries | Israel, Korea, Republic of | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT03253263 | ||||
Other Study ID Numbers ICMJE | OHB-607-202 2018-001393-16 ( EudraCT Number ) jRCT2071200076 ( Registry Identifier: jRCT ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Oak Hill Bio Ltd ( OHB Neonatology Ltd. ) | ||||
Original Responsible Party | Shire | ||||
Current Study Sponsor ICMJE | OHB Neonatology Ltd. | ||||
Original Study Sponsor ICMJE | Shire | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Oak Hill Bio Ltd | ||||
Verification Date | December 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |