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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03253263
Other study ID # OHB-607-202
Secondary ID 2018-001393-16jR
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 9, 2019
Est. completion date January 21, 2028

Study information

Verified date May 2024
Source Oak Hill Bio Ltd
Contact OHB Contact
Email CMO@Oakhillbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
OHB-607
Participants will receive intravenous infusion of OHB-607 from birth up to PMA 29 weeks + 6 days.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
OHB Neonatology Ltd.

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  Germany,  Ireland,  Italy,  Japan,  Netherlands,  Portugal,  Spain,  Sweden,  United Kingdom, 

References & Publications (2)

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

Outcome

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
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