Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
NCT ID: NCT03695978
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
200 participants
OBSERVATIONAL
2018-02-13
2030-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nuwiq
All patients receiving Nuwiq (recombinant FVIII)
No interventions assigned to this group
Octanate
All patients receiving Octanate (plasma derived FVIII)
No interventions assigned to this group
Wilate
All patients receiving Wilate (plasma derived FVIII/von Willebrand factor \[VWF\])
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Severe haemophilia A (FVIII:C\<1%)
* Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study
* Either
* No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR
* Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if
* data are available on all previous treatment, AND
* they did not develop an inhibitor at any time point, OR
* they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).
* Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian)
Exclusion Criteria
* Concomitant treatment with any systemic immunosuppressive drug
* Participation in an interventional clinical trial during the time period evaluated
* Participation in another non-interventional study of Octapharma
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Octapharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sigurd Knaub, PhD
Role: STUDY_DIRECTOR
Octapharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Miller School of Medicine
Miami, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Cure 4 The Kids Foundation Children's Specialty Center
Las Vegas, Nevada, United States
CENIDOR
Salta, , Argentina
Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia
Baku, , Azerbaijan
Republican Scientific Center for Radiation Medicine and Human Ecology
Homyel, , Belarus
Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology
Minsk, , Belarus
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Cliniques Universitaires Saint-Luc
Brussels, , Belgium
McMaster University, Division of Pediatric Hematology/Oncology Room 3N27
Hamilton, Ontario, Canada
Department of Hematology Research Research Transition Facility
Edmonton, , Canada
University Hospital Centre Zagreb
Zagreb, , Croatia
Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology
Tallinn, , Estonia
CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON
Besançon, , France
CHRU Tours - Hôpital Trousseau
Chambray-lès-Tours, , France
Centre Régional de Traitement de l'hémophilie
Le Mans, , France
Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency
Montmorency, , France
CHU Hotel Dieu, Centre de Traitment de l'Hemophilie
Nantes, , France
Hôspital Necker Enfants Malades
Paris, , France
CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3
Saint-Priest-en-Jarez, , France
Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain
Berlin, , Germany
Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR)
Bonn, , Germany
Coagulation Research Centre GmbH
Duisburg, , Germany
University Hospital Essen
Essen, , Germany
HZRM GmbH
Frankfurt, , Germany
Heim Pál National Pediatric Institute Department of Oncology and Hematology
Budapest, , Hungary
University of Debrecen Department of Pediatrics
Debrecen, , Hungary
Ospedale Pediatrico "Giovani XXIII"
Bari, , Italy
Policlinico Sant'Orsola Malpighi
Bologna, , Italy
Ospedale San Giacomo
Castelfranco Veneto, , Italy
Azienda Ospedaliera-Universitaria Policlinico "Vittorio Emanuele", Centro di Riferimento Regionale per la Prevenzione, Diagnosi e Cura delle Malattie Rare della Coagulazione nel Bambino e neel'Adulto. U.O.C Ematologia con trapianto di Midollo Osseo
Catania, , Italy
Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Ospedale Maggiore Policlinico
Milan, , Italy
Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital
Milan, , Italy
Centro Emofilia - AUO di Padova
Padua, , Italy
Policlinico Umberto I
Rome, , Italy
C.tro Emofilia A.O. Città della salute e della scienza di Torino, Ospedale Regina Margherita
Torino, , Italy
Ospedale Regina Margherita
Turin, , Italy
Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos
Vilnius, , Lithuania
Hospital Infantil de Morelia Eva Sámano de López Mateos
Morelia, , Mexico
Hospital Universitario Dr. José Eleuterio Gonzalez S/N
Nuevo León, , Mexico
SMO and Scientific Services S.A.P.P de C.V
Nuevo León, , Mexico
Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department"
Moscow, , Russia
Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37"
Saint Petersburg, , Russia
Hospital General Universitario de Alicante Hematología y Hemoterapia
Alicante, , Spain
Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia
Barcelona, , Spain
HRU Malaga
Málaga, , Spain
Universitary Hospital Son Espases (Hematology Service)
Palma de Mallorca, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Istanbul University Faculty of Medicine
Fatih, , Turkey (Türkiye)
John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust
Headington, Oxford, United Kingdom
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, , United Kingdom
Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre
London, , United Kingdom
Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Olga Alenjnikowa
Role: primary
Phu Quac Le
Role: primary
An Van Damme
Role: primary
Hassoun Abel
Role: primary
Marc Fouassier
Role: primary
Claire Berger
Role: primary
Johannes Oldenburg
Role: primary
Susan Halimeh
Role: primary
Lelia Validre
Role: primary
Giancarlo Castaman
Role: primary
Elena Santangostino
Role: primary
Antonio Chistolini
Role: primary
Role: backup
Sonata Saulyte Trakymiene
Role: primary
Role: backup
Pascual Marco Vera
Role: primary
Olga Benitez Hidalgo
Role: primary
Neha Bhatnagar
Role: primary
Georgina Hall
Role: backup
Raina Liesner
Role: primary
Tina Biss
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Oldenburg J, Halimeh S, Hall GW, Klamroth R, Vera PM, Jansen M, Mathias M. Design of a Real-World Observational Study in Previously Untreated and Minimally Treated Hemophilia A Patients: Protect-NOW. TH Open. 2023 May 10;7(2):e110-e116. doi: 10.1055/s-0043-1768464. eCollection 2023 Apr.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GENA-25
Identifier Type: -
Identifier Source: org_study_id