NCT03695978Recruiting
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 3 Oct 2018
- Start date
- 13 Feb 2018
- Primary completion date
- Jun 2030
- Lead sponsor
- Octapharma
- Diseases
- Haemophilia
- NCT number
- NCT03695978
What you commit to
- Study type: Observational
- Planned participants: 200
- From 13 Feb 2018 to the primary completion date, Jun 2030
- 58 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with any systemic immunosuppressive drug
Other illness
- Diagnosis with a coagulation disorder other than haemophilia A
Other
- Participation in an interventional clinical trial during the time period evaluated
- Participation in another non-interventional study of Octapharma
Who the study is looking for
- Male and female patients of any age and ethnicity
- 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)
Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CENIDOR Coordinator of this site? Confirm its status | Salta | Argentina | Active, not recruiting |
| Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia Coordinator of this site? Confirm its status | Baku | Azerbaijan | Withdrawn |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Hòpital Universitaire des Enfants Reine Fabiola Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
| Republican Scientific Center for Radiation Medicine and Human Ecology Coordinator of this site? Confirm its status | Homyel | Belarus | Withdrawn |
| Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology Coordinator of this site? Confirm its status | Minsk | Belarus | Recruiting |
| Department of Hematology Research Research Transition Facility Coordinator of this site? Confirm its status | Edmonton | Canada | Completed |
| McMaster University, Division of Pediatric Hematology/Oncology Room 3N27 Coordinator of this site? Confirm its status | Hamilton | Canada | Withdrawn |
| Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR) Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Coagulation Research Centre GmbH Coordinator of this site? Confirm its status | Duisburg | Germany | Recruiting |
| University Hospital Essen Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| HZRM GmbH Coordinator of this site? Confirm its status | Frankfurt | Germany | Active, not recruiting |
| Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology Coordinator of this site? Confirm its status | Tallinn | Estonia | Withdrawn |
| Hospital General Universitario de Alicante Hematología y Hemoterapia Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital Universitari Vall D'Hebrón, Unitat d'Hemofilia Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| HRU Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| Universitary Hospital Son Espases (Hematology Service) Coordinator of this site? Confirm its status | Palma de Mallorca | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Besançon Coordinator of this site? Confirm its status | Besançon | France | Recruiting |
| The Centre Hospitalier Métropole Savoie Coordinator of this site? Confirm its status | Chambéry | France | Recruiting |
| CHRU Tours - Hopital Trousseau Coordinator of this site? Confirm its status | Chambray-lès-Tours | France | Recruiting |
| Centre Régional de Traitement de l'hémophilie Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
| Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency Coordinator of this site? Confirm its status | Montmorency | France | Recruiting |
| CHU Hotel Dieu, Centre de Traitment de l'Hemophilie Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Hôspital Necker Enfants Malades Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3 Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Birmingham Children's Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Withdrawn |
| John Radcliffe Hospital, Oxford University Hospitals, NHS Foundation Trust Coordinator of this site? Confirm its status | Headington | United Kingdom | Recruiting |
| Great Ormond Street Hospital for Children NHS Trust, Haemophilia Centre Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Newcastle Haemophilia Comprehensive Care Centre, Royal Victoria Infirmary Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Heim Pál National Pediatric Institute Department of Oncology and Hematology Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| University of Debrecen Department of Pediatrics Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Ospedale Pediatrico "Giovani XXIII" Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Policlinico Sant'Orsola-Malpighi Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Ospedale San Giacomo Coordinator of this site? Confirm its status | Castelfranco Veneto | Italy | Completed |
| 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 Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Centro Emofilia - AUO di Padova Coordinator of this site? Confirm its status | Padova | Italy | Withdrawn |
| Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| C.tro Emofilia A.O. Città della salute e della scienza di Torino, Ospedale Regina Margherita Coordinator of this site? Confirm its status | Torino | Italy | Recruiting |
| Ospedale Regina Margherita Coordinator of this site? Confirm its status | Turin | Italy | Withdrawn |
| Children's Hospital Affiliate of Vilnius Universtity Hospital Santaros Klinikos Coordinator of this site? Confirm its status | Vilnius | Lithuania | Recruiting |
| Hospital General de Occidente, Unidad de Hemato-Oncologia Pediatric, Av. Zoquipan 1050, Col Seattle, , Col Seattle Coordinator of this site? Confirm its status | Jalisco | Mexico | Recruiting |
| Hospital Infantil de Morelia Eva Sámano de López Mateos Coordinator of this site? Confirm its status | Morelia | Mexico | Not yet recruiting |
| SMO and Scientific Services S.A.P.P de C.V Coordinator of this site? Confirm its status | Nuevo León | Mexico | Not yet recruiting |
| Hospital Universitario Dr. José Eleuterio Gonzalez S/N Coordinator of this site? Confirm its status | Nuevo León | Mexico | Not yet recruiting |
| Moscow State Government-financed Public Healthcare Institution "Morozovskaya Children Clinical Hospital of Moscow Healthcare Department" Coordinator of this site? Confirm its status | Moscow | Russia | Withdrawn |
| Saint-Petersburg State Budget Healthcare Institution "City Out-patient Clinical # 37" Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Withdrawn |
| Cure 4 The Kids Foundation Children's Specialty Center Coordinator of this site? Confirm its status | Las Vegas | United States | Withdrawn |
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Active, not recruiting |
| The University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Not yet recruiting |
| St. Louis University , 221 North Grand Boulevard Coordinator of this site? Confirm its status | St Louis | United States | Not yet recruiting |
| Istanbul University Faculty of Medicine Coordinator of this site? Confirm its status | Fatih | Turkey (Türkiye) | Withdrawn |
This page is information, not medical advice. Discuss any trial with your doctor.