Status:
RECRUITING
Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients
Lead Sponsor:
Octapharma
Conditions:
Haemophilia A
Eligibility:
All Genders
Brief 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 previo...
Detailed Description
Octapharma's FVIII concentrates have been tested in clinical trials and registered for treatment of haemophilia A; however, as haemophilia A is a rare disease, the numbers of patients treated in studi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03695978
Start Date
February 13 2018
End Date
June 1 2030
Last Update
November 10 2025
Active Locations (55)
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1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
3
Cure 4 The Kids Foundation Children's Specialty Center
Las Vegas, Nevada, United States, 89109
4
CENIDOR
Salta, Argentina