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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - Diagnosis with a coagulation disorder other than haemophilia A - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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) Exclusion Criteria: * Diagnosis with a coagulation disorder other than haemophilia A * 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

Locations (20)

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