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RECRUITING

NCT03253263

PHASE2

A Clinical Efficacy and Safety Study of OHB-607 in Preventing Bronchopulmonary Dysplasia in Extremely Premature Infants

Sponsor: OHB Neonatology Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

0 Hours - 24 Hours

Study Type

INTERVENTIONAL

Enrollment

338

Start Date

2019-05-09

Completion Date

2028-01-21

Last Updated

2026-01-07

Healthy Volunteers

Conditions

Bronchopulmonary Dysplasia Chronic Lung Disease of Prematurity Intraventricular Hemorrhage Retinopathy of Prematurity (ROP)

Interventions

DRUG

OHB-607

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

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. 9. Birth mother with known HIV or hepatitis (B, C, or E) infection.

Locations (66)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Children's Hospital of Orange County

California City, California, United States

LAC USC Medical Center

Los Angeles, California, United States

Jackson Memorial Hospital

Miami, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Memorial Hospital of South Bend

South Bend, Indiana, United States

Norton Children's Hospital

Louisville, Kentucky, United States

Ochsner Baptist Medical Center

New Orleans, Louisiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Minnesota - Children's Hospital and Clinics - St. Paul

Saint Paul, Minnesota, United States

Children's Minnesota - Children's Hospital and Clinics

Saint Paul, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of Rochester

Rochester, New York, United States

Maria Fareri Children's Hospital

Valhalla, New York, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Medical University of South Carolina Children Hospital

Charleston, South Carolina, United States

UVA Children's Hospital

Charlottesville, Virginia, United States

Virginia Commonwealth University - Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Royal Hospital for Women

Randwick, New South Wales, Australia

Royal Women's Hospital

Parkville, Australia

Mater Misericordiae Limited

South Brisbane, Australia

Sainte Justine Hospital

Montreal, Quebec, Canada

Mount Sinai Hospital

Toronto, Canada

Oulun Yliopistollinen Sairaala

Oulu, Finland

Hôpital Antoine Béclère

Clamart, Hauts-de-Seine, France

Groupe Hospitalier Necker Enfants Malades

Paris, France

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Universitatsklinikum Leipzig

Leipzig, Saxony, Germany

Klinikum Nürnberg

Nuremberg, Germany

Cork University Maternity Hospital

Cork, Wilton, Ireland

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Azienda Ospedaliera Di Padova

Padova, Veneto, Italy

Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale

Florence, Italy

Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e

Genova, Italy

Presidio Ospedaliero Di Treviso Ca' Foncello

Treviso, Italy

Kagoshima City Hospital

Kagoshima, Kagoshima-ken, Japan

Nagano Children's Hospital

Azumino, Nagano, Japan

Kurashiki Central Hospital

Kurashiki-shi, Okayama-ken, Japan

Saitama Medical Center

Kawagoe-shi, Saitama, Japan

Showa Medical University Hospital

Tokyo, Japan

Tokyo Metropolitan Children's Medical Center

Tokyo, Japan

Osaka Women's and Children's Hospital

Izumi, Ôsaka, Japan

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Academisch Medisch Centrum Amsterdam

Amsterdam-Zuidoost, North Holland, Netherlands

Wilhelmina Children Hospital-University Medical Center Utrecht

Utrecht, Netherlands

Hospital Garcia de Orta

Almada, Portugal

Maternidade Alfredo da Costa

Lisbon, Portugal

Centro Hospitalar Lisboa

Lisbon, Portugal

Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.

Porto, Portugal

Hospital General Universitario Dr. Balmis

Alicante, Spain

Skanes Universitetssjukhus

Lund, Sweden

Karolinska Solna

Stockholm, Sweden

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital

Chertsey, Surrey, United Kingdom

University of Cambridge

Cambridge, United Kingdom

University Hospital Coventry

Coventry, United Kingdom

Liverpool Women's Hospital - PPDS

Liverpool, United Kingdom

University College London

London, United Kingdom

Chelsea and Westminster NHS Trust