Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients

What this study is about

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 can join (things the study team will check)

✅ You may be able to join if…

• 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)

🚫 You may not be able to join if…

• 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

Where this trial is running

• University of Miami Miller School of Medicine, Miami, Florida, United States
• Ochsner Clinic Foundation, New Orleans, Louisiana, United States
• St. Louis University , 221 North Grand Boulevard, St Louis, Missouri, United States
• Cure 4 The Kids Foundation Children's Specialty Center, Las Vegas, Nevada, United States
• The University of Texas Health Science Center at San Antonio, San Antonio, Texas, 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

+ 47 more sites.

Who to contact

Cristina Solomon, MD · +41 79 585 90 42 · Cristina.Solomon@octapharma.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT03695978.