A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants
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
3 other identifiers
interventional
338
14 countries
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Longer than P75 for phase_2
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2017
CompletedFirst Posted
Study publicly available on registry
August 17, 2017
CompletedStudy Start
First participant enrolled
May 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2028
ExpectedJanuary 7, 2026
January 1, 2026
6.7 years
August 15, 2017
January 5, 2026
Conditions
Outcome Measures
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.
Severe BPD is defined by the modified NICHD severity grading
Baseline through 36 weeks postmenstrual age (PMA)
Secondary Outcomes (18)
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)
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
- +13 more secondary outcomes
Study Arms (2)
OHB-607
EXPERIMENTALParticipants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
Standard Neonatal Care
NO INTERVENTIONStandard neonatal care alone will be provided.
Interventions
Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3500, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72202-3500, United States
Children's Hospital of Orange County
California City, California, 92868, United States
LAC USC Medical Center
Los Angeles, California, 90033-1804, United States
Jackson Memorial Hospital
Miami, Florida, 33136-1005, United States
Tampa General Hospital
Tampa, Florida, 33606-3571, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601-1078, United States
Norton Children's Hospital
Louisville, Kentucky, 40202, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115, United States
Tufts Medical Center
Boston, Massachusetts, 02111-1553, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Children's Minnesota - Children's Hospital and Clinics - St. Paul
Saint Paul, Minnesota, 55102, United States
Children's Minnesota - Children's Hospital and Clinics
Saint Paul, Minnesota, 55102, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4500, United States
University of Rochester
Rochester, New York, 14627, United States
Maria Fareri Children's Hospital
Valhalla, New York, 10595, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Medical University of South Carolina Children Hospital
Charleston, South Carolina, 29425-8908, United States
UVA Children's Hospital
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University - Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298-5075, United States
Royal Hospital for Women
Randwick, New South Wales, 2031, Australia
Royal Women's Hospital
Parkville, 3052, Australia
Mater Misericordiae Limited
South Brisbane, Qld 4101, Australia
Sainte Justine Hospital
Montreal, Quebec, Canada
Mount Sinai Hospital
Toronto, M5G 1X5, Canada
Oulun Yliopistollinen Sairaala
Oulu, 90220, Finland
Hôpital Antoine Béclère
Clamart, Hauts-de-Seine, 92140, France
Groupe Hospitalier Necker Enfants Malades
Paris, 75015, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Klinikum Nürnberg
Nuremberg, 90479, Germany
Cork University Maternity Hospital
Cork, Wilton, T12YE02, Ireland
Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 00168, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
Azienda Ospedaliera Di Padova
Padua, Veneto, 35128, Italy
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale
Florence, 50134, Italy
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e
Genova, 16147, Italy
Presidio Ospedaliero Di Treviso Ca' Foncello
Treviso, 31100, Italy
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, 890-0055, Japan
Nagano Children's Hospital
Azumino, Nagano, 399-8205, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, 710-0052, Japan
Saitama Medical Center
Kawagoe-shi, Saitama, 350-8550, Japan
Showa Medical University Hospital
Tokyo, 142-8666, Japan
Tokyo Metropolitan Children's Medical Center
Tokyo, 183-8561, Japan
Osaka Women's and Children's Hospital
Izumi, Ôsaka, 594-1101, Japan
Maastricht University Medical Center
Maastricht, Limburg, 6229 HX, Netherlands
Academisch Medisch Centrum Amsterdam
Amsterdam-Zuidoost, North Holland, 1105 AZ, Netherlands
Wilhelmina Children Hospital-University Medical Center Utrecht
Utrecht, 3584 EA, Netherlands
Hospital Garcia de Orta
Almada, 2801-951, Portugal
Maternidade Alfredo da Costa
Lisbon, 1069-089, Portugal
Centro Hospitalar Lisboa
Lisbon, 1649-035, Portugal
Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.
Porto, 4050-651, Portugal
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Skanes Universitetssjukhus
Lund, SE-22185, Sweden
Karolinska Solna
Stockholm, 171 76, Sweden
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY, United Kingdom
Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital
Chertsey, Surrey, KT16 0PZ, United Kingdom
University of Cambridge
Cambridge, CB2 0QQ, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Liverpool Women's Hospital - PPDS
Liverpool, L69 3BX, United Kingdom
University College London
London, NW1 2BU, United Kingdom
Chelsea and Westminster NHS Trust
London, SW3 6JJ, United Kingdom
St. Mary's Hospital
Manchester, M13 9WL, United Kingdom
Related Publications (4)
Kramer BW, Abman S, Daly M, Jobe AH, Niklas V. Insulin-like growth factor-1 replacement therapy after extremely premature birth: An opportunity to optimize lifelong lung health by preserving the natural sequence of lung development. Paediatr Respir Rev. 2023 Dec;48:24-29. doi: 10.1016/j.prrv.2023.05.001. Epub 2023 May 6.
PMID: 37268507BACKGROUNDLey D, Hallberg B, Hansen-Pupp I, Dani C, Ramenghi LA, Marlow N, Beardsall K, Bhatti F, Dunger D, Higginson JD, Mahaveer A, Mezu-Ndubuisi OJ, Reynolds P, Giannantonio C, van Weissenbruch M, Barton N, Tocoian A, Hamdani M, Jochim E, Mangili A, Chung JK, Turner MA, Smith LEH, Hellstrom A; study team. rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial. J Pediatr. 2019 Mar;206:56-65.e8. doi: 10.1016/j.jpeds.2018.10.033. Epub 2018 Nov 22.
PMID: 30471715BACKGROUNDBaraldi E, De Luca D, Bonadies L, Hirano S, Kusuda S, Bancalari E, Ramanathan R, Barton N, Nickless A, Lee J, Mahajan N, Niklas V. Randomised al.Phase 2b trial of rhIGF-1/rhIGFBP-3 (OHB-607) for bronchopulmonary dysplasia prevention in preterm neonates: study protocol. BMJ Paediatr Open. 2026 Mar 5;10(1):e004196. doi: 10.1136/bmjpo-2025-004196.
PMID: 41786363DERIVEDHellstrom 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. 2023 Feb;93(3):666-674. doi: 10.1038/s41390-022-02134-4. Epub 2022 Jun 9.
PMID: 35681088DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2017
First Posted
August 17, 2017
Study Start
May 9, 2019
Primary Completion
January 23, 2026
Study Completion (Estimated)
January 21, 2028
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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.