Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Condition(s) studied
Study summary
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.
Eligibility
Primary outcome measure(s)
- Annualised rate of breakthrough bleeds to assess efficacy in prophylactic treatment — 100 exposure days
Annualised rate of all bleeding events (BEs), including all spontaneous, traumatic and joint BEs - Incidence of Adverse Drug Reactions (ADRs) — 100 exposure days
Adverse drug reactions (ADRs) including hypersensitivity reactions will be recorded in by patients in treatment diaries, which will be reviewed at each Follow-up Visit.
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Active Not Recruiting |
| St. Louis University , 221 North Grand Boulevard | St Louis | Missouri | Not Yet Recruiting |
| Cure 4 The Kids Foundation Children's Specialty Center | Las Vegas | Nevada | Withdrawn |
| The University of Texas Health Science Center at San Antonio | San Antonio | Texas | Not Yet Recruiting |
| CENIDOR | Salta | Argentina | Active Not Recruiting |
| Azerbaijan State Advanced Training Institute for Doctors Hematology Department Scientific-Research Center of Hemophilia | Baku | Azerbaijan | Withdrawn |
| Republican Scientific Center for Radiation Medicine and Human Ecology | Homyel | Belarus | Withdrawn |
| Republican Scientific and Practical Centre of Children Oncology, Hematology and Immunology | Minsk | Belarus | Recruiting |
| Hôpital Universitaire des Enfants Reine Fabiola | Brussels | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Recruiting |
| McMaster University, Division of Pediatric Hematology/Oncology Room 3N27 | Hamilton | Ontario | Withdrawn |
| Department of Hematology Research Research Transition Facility | Edmonton | Canada | Completed |
| University Hospital Centre Zagreb | Zagreb | Croatia | Recruiting |
| Tallinn Childrenś Hospital Clinic of Paediatric Department of Haematology and Oncology | Tallinn | Estonia | Withdrawn |
| CENTRE HOSPITALIER UNIVERSITAIRE de BESANCON | Besançon | France | Recruiting |
| The Centre Hospitalier Métropole Savoie | Chambéry | France | Recruiting |
| CHRU Tours - Hôpital Trousseau | Chambray-lès-Tours | France | Recruiting |
| Centre Régional de Traitement de l'hémophilie | Le Mans | France | Recruiting |
| Hopital Simone Veil Groupement Hospitalier Eaubonne-Montmorency | Montmorency | France | Recruiting |
| CHU Hotel Dieu, Centre de Traitment de l'Hemophilie | Nantes | France | Recruiting |
| Hôspital Necker Enfants Malades | Paris | France | Recruiting |
| CHRU Hopital Nord, Secretariat de pediatre, bat E niv +3 | Saint-Priest-en-Jarez | France | Recruiting |
| Vivantes - Netzwerk für Gesundheit GmbH Klinikum im Friedrichshain | Berlin | Germany | Active Not Recruiting |
| Institute of Experimental Haematology and Transfusion Medicine (IHT) University Clinic Bonn (AöR) | Bonn | Germany | Recruiting |
| Coagulation Research Centre GmbH | Duisburg | Germany | Recruiting |
| University Hospital Essen | Essen | Germany | Active Not Recruiting |
| HZRM GmbH | Frankfurt | Germany | Active Not Recruiting |
| Heim Pál National Pediatric Institute Department of Oncology and Hematology | Budapest | Hungary | Recruiting |
| University of Debrecen Department of Pediatrics | Debrecen | Hungary | Recruiting |
| Ospedale Pediatrico "Giovani XXIII" | Bari | Italy | Recruiting |
| Policlinico Sant'Orsola Malpighi | Bologna | Italy | Recruiting |
| Ospedale San Giacomo | 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 | Catania | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Careggi | Florence | Italy | Recruiting |
| Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Center for Thrombosis and Hemorrhagic Diseases, IRCCS Humanitas Research Hospital | Milan | Italy | Recruiting |
| Centro Emofilia - AUO di Padova | Padova | Italy | Withdrawn |
| Policlinico Umberto I | Rome | Italy | Recruiting |
+ 19 more sites — see the full list on the official registry below.
More Octapharma trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03695978 on ClinicalTrials.gov ↗ ← All trials in the USA