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
Who is this study for? Patients with Bronchopulmonary Dysplasia, Retinopathy of Prematurity
What treatments are being studied? SHP607
Status: Active_not_recruiting
Location: See all (62) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 1 day
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Arkansas Children's Hospital
Little Rock
University of Arkansas for Medical Sciences
Little Rock
California
Children's Hospital of Orange County
California City
Cedars Sinai Medical Center
Los Angeles
US Davis
Sacramento
Florida
Jackson Memorial Hospital
Miami
Tampa General Hospital
Tampa
Illinois
University of Illinois at Chicago
Chicago
Indiana
Riley Hospital for Children
Indianapolis
Memorial Hospital of South Bend
South Bend
Kentucky
University of Louisville Hospital
Louisville
Louisiana
Ochsner Baptist Medical Center
New Orleans
Massachusetts
Tufts Medical Center
Boston
Minnesota
Children's Minnesota - Children's Hospital and Clinics
Saint Paul
Children's Minnesota - Children's Hospital and Clinics - St. Paul
Saint Paul
Mississippi
University of Mississippi Medical Center
Jackson
New York
University of Rochester
Rochester
Maria Fareri Children's Hospital
Valhalla
Oklahoma
Oklahoma Children's Hospital - PIN
Oklahoma City
South Carolina
Medical University of South Carolina Children Hospital
Charleston
Texas
Texas Children's Hospital
Houston
UT Health Science Center
San Antonio
Virginia
UVA Children's Hospital
Charlottesville
Virginia Commonwealth University - Children's Hospital of Richmond at VCU
Richmond
Other Locations
Australia
Royal Women's Hospital
Parkville
Royal Hospital for Women
Randwick
Mater Misericordiae Limited
South Brisbane
Westmead Hospital
Westmead
Canada
Sainte Justine Hospital
Montreal
Finland
Oulun Yliopistollinen Sairaala
Oulu
Germany
Universitatsklinikum Leipzig
Leipzig
Klinikum Nürnberg
Nuremberg
Ireland
Cork University Maternity Hospital
Cork
Italy
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale
Florence
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e
Genova
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan
Azienda Ospedaliera Di Padova
Padova
Presidio Ospedaliero Di Treviso Ca' Foncello
Treviso
Japan
Nagano Children's Hospital
Azumino
Osaka Women's and Children's Hospital
Izumi
Saitama Medical Center
Kawagoe-shi
Kurashiki Central Hospital
Kurashiki-shi
Saitama Prefectural Children's Medical Center
Saitama
National Center for Child Health and Development
Tokyo
Showa Medical University Hospital
Tokyo
Tokyo Metropolitan Children's Medical Center
Tokyo
Netherlands
Academisch Medisch Centrum Amsterdam
Amsterdam-zuidoost
Maastricht University Medical Center
Maastricht
Wilhelmina Children Hospital-University Medical Center Utrecht
Utrecht
Portugal
Hospital Garcia de Orta
Almada
Centro Hospitalar Lisboa
Lisbon
Maternidade Alfredo da Costa
Lisbon
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
United Kingdom
University of Cambridge
Cambridge
Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital
Chertsey
University Hospital Coventry
Coventry
Liverpool Women's Hospital - PPDS
Liverpool
Chelsea and Westminster NHS Trust
London
St. Mary's Hospital
Manchester
Norfolk and Norwich University Hospital
Norwich
Time Frame
Start Date: 2019-05-09
Completion Date: 2028-01-21
Participants
Target number of participants: 295
Treatments
Experimental: OHB-607
Participants will receive continuous IV infusion of OHB-607 through from birth up to PMA 29 weeks +6 days.
No_intervention: Standard Neonatal Care
Standard neonatal care alone will be provided.
Authors
Amanda English, Rachana Singh, Amanda England, Joseph Ginski, Manoj Biniwale, Eduardo Bautista, Nitin Chouthai, Carol Wagner, Fabien Eyal, Jeffrey Garland, Henry Rozycki, Sherry Courtney, Meena Garg, Faizah Bhatti, Basharat Buchh, Abhay Bhatt, Mark Polak, Neena Modi, Peter Reynolds, Ajit Mahaveer, Paul Clarke, Giles Kendall, Andre Graca, Alexander Rakow, Teresa Tomé, Satoshi Ibara, Gregory Lodygensky, Shinya Hirano, Mikko Hallman, Takehiko Hiroma, Fabio Mosca, Carlo Dani, Paola Lago, Eugenio Baraldi, Giovanni Vento, David Bader, David Ley, Fumihiko Namba, Luca Ramenghi
Related Therapeutic Areas
Sponsors
Leads: OHB Neonatology Ltd.