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: Recruiting
Location: See all (61) 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
RECRUITING
Little Rock
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
Children's Hospital of Orange County
RECRUITING
California City
LAC USC Medical Center
ACTIVE_NOT_RECRUITING
Los Angeles
Florida
Jackson Memorial Hospital
RECRUITING
Miami
Tampa General Hospital
RECRUITING
Tampa
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Memorial Hospital of South Bend
RECRUITING
South Bend
Kentucky
Norton Children's Hospital
RECRUITING
Louisville
Louisiana
Ochsner Baptist Medical Center
RECRUITING
New Orleans
Massachusetts
Boston Children's Hospital
WITHDRAWN
Boston
Tufts Medical Center
RECRUITING
Boston
Minnesota
Children's Minnesota - Children's Hospital and Clinics
RECRUITING
Saint Paul
Children's Minnesota - Children's Hospital and Clinics - St. Paul
RECRUITING
Saint Paul
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
New York
University of Rochester
RECRUITING
Rochester
Maria Fareri Children's Hospital
RECRUITING
Valhalla
Ohio
Nationwide Children's Hospital
NOT_YET_RECRUITING
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
South Carolina
Medical University of South Carolina Children Hospital
RECRUITING
Charleston
Virginia
UVA Children's Hospital
RECRUITING
Charlottesville
Virginia Commonwealth University - Children's Hospital of Richmond at VCU
RECRUITING
Richmond
Other Locations
Canada
Sainte Justine Hospital
RECRUITING
Montreal
Mount Sinai Hospital
WITHDRAWN
Toronto
Finland
Oulun Yliopistollinen Sairaala
RECRUITING
Oulu
France
Hôpital Antoine Béclère
ACTIVE_NOT_RECRUITING
Clamart
Groupe Hospitalier Necker Enfants Malades
ACTIVE_NOT_RECRUITING
Paris
Germany
Universitätsklinikum Freiburg
WITHDRAWN
Freiburg Im Breisgau
Universitatsklinikum Leipzig
RECRUITING
Leipzig
Klinikum Nürnberg
RECRUITING
Nuremberg
Ireland
Cork University Maternity Hospital
ACTIVE_NOT_RECRUITING
Cork
Italy
Azienda Ospedaliero-Universitaria Careggi SOD Neonatologia e Terapia Intensiva Neonatale
RECRUITING
Florence
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e
RECRUITING
Genova
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
Azienda Ospedaliera Di Padova
RECRUITING
Padua
Fondazione Policlinico Universitario A Gemelli
RECRUITING
Rome
Presidio Ospedaliero Di Treviso Ca' Foncello
RECRUITING
Treviso
Japan
Nagano Children's Hospital
RECRUITING
Azumino
Osaka Women's and Children's Hospital
RECRUITING
Izumi
Kagoshima City Hospital
ACTIVE_NOT_RECRUITING
Kagoshima
Saitama Medical Center
ACTIVE_NOT_RECRUITING
Kawagoe-shi
Kurashiki Central Hospital
RECRUITING
Kurashiki-shi
Netherlands
Academisch Medisch Centrum Amsterdam
RECRUITING
Amsterdam-zuidoost
Maastricht University Medical Center
RECRUITING
Maastricht
Wilhelmina Children Hospital-University Medical Center Utrecht
RECRUITING
Utrecht
Portugal
Hospital Garcia de Orta
RECRUITING
Almada
Centro Hospitalar Lisboa
RECRUITING
Lisbon
Maternidade Alfredo da Costa
RECRUITING
Lisbon
Centro Materno Infantil do Norte - Centro Hospital Universitario do Porto, E.P.E.
RECRUITING
Porto
Spain
Hospital General Universitario Dr. Balmis
RECRUITING
Alicante
Sweden
Skanes Universitetssjukhus
COMPLETED
Lund
Karolinska Solna
WITHDRAWN
Stockholm
United Kingdom
University of Cambridge
RECRUITING
Cambridge
Ashford and St. Peter's Hospitals NHS Trust - St. Peter's Hospital
COMPLETED
Chertsey
University Hospital Coventry
RECRUITING
Coventry
Liverpool Women's Hospital - PPDS
RECRUITING
Liverpool
Chelsea and Westminster NHS Trust
RECRUITING
London
University College London
WITHDRAWN
London
St. Mary's Hospital
RECRUITING
Manchester
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Contact Information
Primary
OHB Contact
CMO@Oakhillbio.com
Time Frame
Start Date: 2019-05-09
Estimated Completion Date: 2028-01-21
Participants
Target number of participants: 338
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, Jeffrey Garland, Joseph Ginski, Manoj Biniwale, Eduardo Bautista, Nitin Chouthai, Carol Wagner, Fabien Eyal, Henry Rozycki, Sherry Courtney, Meena Garg, Faizah Bhatti, Basharat Buchh, Abhay Bhatt, Surasak Puvabanditsin, Neena Modi, Peter Reynolds, Ajit Mahaveer, Paul Clarke, Giles Kendall, Andre Graca, Paola Lago, Takehiko Hiroma, Alexander Rakow, David Ley, Mark Polak, Gregory Lodygensky, Fabio Mosca, Shinya Hirano, Luca Ramenghi, Fumihiko Namba, Carlo Dani, Giovanni Vento, Eugenio Baraldi, Mikko Hallman, David Bader, Satoshi Ibara
Related Therapeutic Areas
Sponsors
Leads: OHB Neonatology Ltd.