Bronchopulmonary Dysplasia Clinical Trial
Official title:
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
Verified date | May 2024 |
Source | Oak Hill Bio Ltd |
Contact | OHB Contact |
CMO[@]Oakhillbio.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 338 |
Est. completion date | January 21, 2028 |
Est. primary completion date | January 23, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Hours to 24 Hours |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Sainte Justine Hospital | Montreal | Quebec |
Canada | Mount Sinai Hospital | Toronto | |
Finland | Oulun Yliopistollinen Sairaala | Oulu | |
France | Hôpital Antoine Béclère | Clamart | Hauts-de-Seine |
France | Groupe Hospitalier Necker Enfants Malades | Paris | |
Germany | Universitätsklinikum Freiburg | Freiburg | Baden-Württemberg |
Germany | Universitatsklinikum Leipzig | Leipzig | Sachsen |
Germany | Klinikum Nürnberg | Nürnberg | |
Ireland | Cork University Maternity Hospital | Cork | Wilton |
Italy | Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale | Firenze | |
Italy | Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e | Genova | |
Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milano | Lombardia |
Italy | Azienda Ospedaliera Di Padova | Padova | Veneto |
Italy | Fondazione Policlinico Universitario A Gemelli | Roma | Lazio |
Italy | Presidio Ospedaliero Di Treviso Ca' Foncello | Treviso | |
Japan | Nagano Children's Hospital | Azumino | Nagano |
Japan | Osaka Women's and Children's Hospital | Izumi | Ôsaka |
Japan | Kagoshima City Hospital | Kagoshima-shi | Kagosima |
Japan | Saitama Medical Center | Kawagoe-shi | Saitama |
Japan | Kurashiki Central Hospital | Kurashiki-shi | Okayama |
Netherlands | Academisch Medisch Centrum Amsterdam | Amsterdam-Zuidoost | Noord-Holland |
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Netherlands | Wilhelmina Children Hospital-University Medical Center Utrecht | Utrecht | |
Portugal | Hospital Garcia de Orta | Almada | |
Portugal | Centro Hospitalar Lisboa | Lisboa | |
Portugal | Maternidade Alfredo da Costa | Lisboa | |
Portugal | Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E. | Porto | |
Spain | Hospital General Universitario Dr. Balmis | Alicante | |
Sweden | Skanes Universitetssjukhus | Lund | |
Sweden | Karolinska Solna | Stockholm | |
United Kingdom | University of Cambridge | Cambridge | |
United Kingdom | Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital | Chertsey | Surrey |
United Kingdom | University Hospital Coventry | Coventry | |
United Kingdom | Liverpool Women's Hospital - PPDS | Liverpool | |
United Kingdom | Chelsea and Westminster NHS Trust | London | |
United Kingdom | University College London | London | |
United Kingdom | St. Mary's Hospital | Manchester | |
United Kingdom | Norfolk and Norwich University Hospital | Norwich | Norfolk |
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Tufts Medical Center | Boston | Massachusetts |
United States | Medical University of South Carolina Children Hospital | Charleston | South Carolina |
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | LAC USC Medical Center | Los Angeles | California |
United States | Jackson Memorial Hospital | Miami | Florida |
United States | Ochsner Baptist Medical Center | New Orleans | Louisiana |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Virginia Commonwealth University - Children's Hospital of Richmond at VCU | Richmond | Virginia |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Tampa General Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
OHB Neonatology Ltd. |
United States, Canada, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Portugal, Spain, Sweden, United Kingdom,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | ||
Secondary | 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 | ||
Secondary | 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 | ||
Secondary | Chronic respiratory morbidity outcomes at 24 months CA | 24 months CA | ||
Secondary | Incidence and severity of BPD | BPD severity is defined by the modified NICHD severity grading | Baseline through 36 weeks postmenstrual age (PMA) | |
Secondary | 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) | ||
Secondary | 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) | |
Secondary | 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 | |
Secondary | Incidence of Retinopathy of Prematurity (ROP) | ROP is classified according to the International Classification | Baseline through 40 weeks PMA | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04506619 -
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
|
||
Completed |
NCT04936477 -
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
|
N/A | |
Recruiting |
NCT05285345 -
Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
|
||
Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
Terminated |
NCT02524249 -
Early Versus Late Caffeine for ELBW Newborns
|
N/A | |
Completed |
NCT02249143 -
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
|
N/A | |
Active, not recruiting |
NCT01632475 -
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
|
||
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
Completed |
NCT00419588 -
Growth of Airways and Lung Tissues in Premature and Healthy Infants
|
||
Completed |
NCT00208039 -
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
|
N/A | |
Completed |
NCT00319956 -
Trial II of Lung Protection With Azithromycin in the Preterm Infant
|
Phase 2 | |
Completed |
NCT00006401 -
Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
|
Phase 3 | |
Terminated |
NCT05030012 -
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
|
N/A | |
Completed |
NCT00006058 -
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
|
N/A | |
Completed |
NCT00005376 -
Premature Birth and Its Sequelae in Women
|
N/A | |
Completed |
NCT00011362 -
Dexamethasone Therapy in VLBW Infants at Risk of CLD
|
Phase 3 | |
Completed |
NCT00004805 -
Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death
|
N/A | |
Completed |
NCT05152316 -
The Baby Lung Study
|
||
Recruiting |
NCT04821453 -
NAVA vs. CMV Crossover in Severe BPD
|
N/A |