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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001393-16 | EudraCT Number | ||
| jRCT2071200076 | Registry Identifier | jRCT |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OHB-607 | Experimental | Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days. |
|
| Standard Neonatal Care | No Intervention | Standard neonatal care alone will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OHB-607 | Drug | Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The final weaning off of RTS is defined as the 7th consecutive day that the subject is off RTS. | Baseline through 12 months CA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| OHB Contact | Contact | CMO@Oakhillbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arkansas Children's Hospital | Recruiting | Little Rock | Arkansas | 72202-3500 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37268507 | Background | 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. | |
| 30471715 |
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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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| 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. |
Severe BPD is defined based on the classification according to Jensen et al., 2019 |
| 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 | Severe IVH as classified according to the Volpe criteria | 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 |
| 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: Determined by the separate BSID III scales at 24 months CA |
| Chronic respiratory morbidity outcomes at 24 months CA | 24 months CA |
| Incidence and severity of BPD | BPD severity is defined by the modified NICHD severity grading | Baseline through 36 weeks postmenstrual age (PMA) |
| 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 | 36 weeks weeks postmenstrual age (PMA) (± 3 days) |
| Incidence and severity of IVH | Incidence of all grades of IVH as assessed by centrally read CUS and classified according to the Volpe criteria | Baseline through 36 weeks postmenstrual age (PMA) |
| Neurodevelopment outcomes | Neurodevelopmental impairment, Physical and cognitive development will be measured by ASQ®-3 administered at 12 and 24 months CA. | From 6 months CA through 24 months CA |
| Incidence of Retinopathy of Prematurity (ROP) | ROP is classified according to the International Classification | Baseline through 40 weeks PMA |
| Mortality from randomization through to 24 months CA | Mortality rates from randomization to initial hospital discharge and from initial discharge through 24 months CA. | From birth through 24 months CA |
| Exposure-response relationship between measured IGF-1 and Bronchopulmonary Dysplasia (BPD) | Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of BPD | Baseline through 36 weeks PMA |
| Exposure-response relationship between measured IGF-1 and intraventricular hemorrhage (IVH) | Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of IVH | Baseline through 40 weeks PMA |
| Exposure-response relationship between measured IGF-1 and necrotizing enterocolitis (NEC) | Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of NEC | Baseline through 40 weeks PMA |
| Exposure-response relationship between measured IGF-1 and Retinopathy of Prematurity (ROP) | Blood samples will be collected to measure IGF-1 and these measured values will be associated with the incidence and severity grade of ROP | Baseline through 40 weeks PMA |
| To assess the safety profile of OHB-607 as compared to the SNC group. | 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. | Baseline through 24 months CA |
| University of Arkansas for Medical Sciences |
| Recruiting |
| Little Rock |
| Arkansas |
| 72202-3500 |
| United States |
| Children's Hospital of Orange County | Recruiting | California City | California | 92868 | United States |
| LAC USC Medical Center | Active, not recruiting | Los Angeles | California | 90033-1804 | United States |
| US Davis | Recruiting | Sacramento | California | 95817 | United States |
| Jackson Memorial Hospital | Recruiting | Miami | Florida | 33136-1005 | United States |
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606-3571 | United States |
| University of Illinois at Chicago | Recruiting | Chicago | Illinois | 60612 | United States |
| Riley Hospital for Children | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Memorial Hospital of South Bend | Recruiting | South Bend | Indiana | 46601-1078 | United States |
| Norton Children's Hospital | Recruiting | Louisville | Kentucky | 40202 | United States |
| Ochsner Baptist Medical Center | Recruiting | New Orleans | Louisiana | 70115 | United States |
| Tufts Medical Center | Recruiting | Boston | Massachusetts | 02111-1553 | United States |
| Boston Children's Hospital | Withdrawn | Boston | Massachusetts | 02115 | United States |
| Children's Minnesota - Children's Hospital and Clinics - St. Paul | Recruiting | Saint Paul | Minnesota | 55102 | United States |
| Children's Minnesota - Children's Hospital and Clinics | Recruiting | Saint Paul | Minnesota | 55102 | United States |
| University of Mississippi Medical Center | Recruiting | Jackson | Mississippi | 39216-4500 | United States |
| University of Rochester | Recruiting | Rochester | New York | 14627 | United States |
| Maria Fareri Children's Hospital | Recruiting | Valhalla | New York | 10595 | United States |
| Nationwide Children's Hospital | Not yet recruiting | Columbus | Ohio | 43205 | United States |
| University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Medical University of South Carolina Children Hospital | Recruiting | Charleston | South Carolina | 29425-8908 | United States |
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
| UT Health Science Center | Recruiting | San Antonio | Texas | 78229 | United States |
| UVA Children's Hospital | Recruiting | Charlottesville | Virginia | 22903 | United States |
| Virginia Commonwealth University - Children's Hospital of Richmond at VCU | Recruiting | Richmond | Virginia | 23298-5075 | United States |
| Royal Hospital for Women | Recruiting | Randwick | New South Wales | 2031 | Australia |
| Westmead Hospital | Recruiting | Westmead | New South Wales | NSW 2145 | Australia |
| Royal Women's Hospital | Recruiting | Parkville | 3052 | Australia |
| Mater Misericordiae Limited | Recruiting | South Brisbane | Qld 4101 | Australia |
| Sainte Justine Hospital | Recruiting | Montreal | Quebec | Canada |
| Mount Sinai Hospital | Withdrawn | Toronto | M5G 1X5 | Canada |
| Oulun Yliopistollinen Sairaala | Recruiting | Oulu | 90220 | Finland |
| Hôpital Antoine Béclère | Active, not recruiting | Clamart | Hauts-de-Seine | 92140 | France |
| Groupe Hospitalier Necker Enfants Malades | Active, not recruiting | Paris | 75015 | France |
| Universitätsklinikum Freiburg | Withdrawn | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| Universitatsklinikum Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
| Klinikum Nürnberg | Recruiting | Nuremberg | 90479 | Germany |
| Cork University Maternity Hospital | Recruiting | Cork | Wilton | T12YE02 | Ireland |
| Fondazione Policlinico Universitario A Gemelli | Recruiting | Rome | Lazio | 00168 | Italy |
| Fondazione IRCCS CÃ Granda Ospedale Maggiore Policlinico | Recruiting | Milan | Lombardy | 20122 | Italy |
| Azienda Ospedaliera Di Padova | Recruiting | Padova | Veneto | 35128 | Italy |
| Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale | Recruiting | Florence | 50134 | Italy |
| Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e | Recruiting | Genova | 16147 | Italy |
| Presidio Ospedaliero Di Treviso Ca' Foncello | Recruiting | Treviso | 31100 | Italy |
| Kagoshima City Hospital | Active, not recruiting | Kagoshima | Kagoshima-ken | 890-0055 | Japan |
| Nagano Children's Hospital | Recruiting | Azumino | Nagano | 399-8205 | Japan |
| Kurashiki Central Hospital | Recruiting | Kurashiki-shi | Okayama-ken | 710-0052 | Japan |
| Saitama Medical Center | Recruiting | Kawagoe-shi | Saitama | 350-8550 | Japan |
| Saitama Prefectural Children's Medical Center | Recruiting | Saitama | Saitama | 330-8777 | Japan |
| Showa Medical University Hospital | Recruiting | Tokyo | 142-8666 | Japan |
| National Center for Child Health and Development | Recruiting | Tokyo | 157-8535 | Japan |
| Tokyo Metropolitan Children's Medical Center | Recruiting | Tokyo | 183-8561 | Japan |
| Osaka Women's and Children's Hospital | Recruiting | Izumi | Ôsaka | 594-1101 | Japan |
| Maastricht University Medical Center | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
| Academisch Medisch Centrum Amsterdam | Recruiting | Amsterdam-Zuidoost | North Holland | 1105 AZ | Netherlands |
| Wilhelmina Children Hospital-University Medical Center Utrecht | Recruiting | Utrecht | 3584 EA | Netherlands |
| Hospital Garcia de Orta | Recruiting | Almada | 2801-951 | Portugal |
| Maternidade Alfredo da Costa | Recruiting | Lisbon | 1069-089 | Portugal |
| Centro Hospitalar Lisboa | Recruiting | Lisbon | 1649-035 | Portugal |
| Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E. | Recruiting | Porto | 4050-651 | Portugal |
| Hospital General Universitario Dr. Balmis | Recruiting | Alicante | 03010 | Spain |
| Skanes Universitetssjukhus | Completed | Lund | SE-22185 | Sweden |
| Karolinska Solna | Withdrawn | Stockholm | 171 76 | Sweden |
| Norfolk and Norwich University Hospital | Recruiting | Norwich | Norfolk | NR4 7UY | United Kingdom |
| Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital | Completed | Chertsey | Surrey | KT16 0PZ | United Kingdom |
| University of Cambridge | Recruiting | Cambridge | CB2 0QQ | United Kingdom |
| University Hospital Coventry | Recruiting | Coventry | CV2 2DX | United Kingdom |
| Liverpool Women's Hospital - PPDS | Recruiting | Liverpool | L69 3BX | United Kingdom |
| University College London | Withdrawn | London | NW1 2BU | United Kingdom |
| Chelsea and Westminster NHS Trust | Recruiting | London | SW3 6JJ | United Kingdom |
| St. Mary's Hospital | Recruiting | Manchester | M13 9WL | United Kingdom |
| Ley 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. |
| 41786363 | Derived | Baraldi 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. |
| 35681088 | Derived | 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. 2023 Feb;93(3):666-674. doi: 10.1038/s41390-022-02134-4. Epub 2022 Jun 9. |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007334 | Insulin-Like Growth Factor I |
| ID | Term |
|---|---|
| D013002 | Somatomedins |
| D000096764 | Insulin-Like Peptides |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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