Status:
COMPLETED
Register of Patients With haEmophilia A tReated With Afstyla®
Lead Sponsor:
CSL Behring
Conditions:
Haemophilia A
Eligibility:
All Genders
Brief Summary
Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or ...
Detailed Description
Haemophilia A is a congenital coagulation disorder caused by a deficiency or abnormality of coagulation factor VIII (FVIII). The severity of the haemophilia depends on the magnitude of the FVIII defi...
Eligibility Criteria
Inclusion
- Have given their agreement to take part in the observational registry after being informed in writing of the purposes of the study and after their data have been recorded (parent's agreement for minor patients);
- Be suffering from haemophilia A and being treated or having been treated with Afstyla® long term prophylactically, on demand or preventatively for a surgical procedure;
- Absence of inhibitor and/or treatment for immune tolerance at the time of inclusion
Exclusion
- Refusal of the patient or the patient's legal representative to take part in the study;
- Existence of a contraindication to the use of Afstyla® treatment (known hypersensitivity to FVIII or hamster proteins);
- Simultaneous participation in an interventional clinical study.
- Presence of an inhibitor and/or ongoing immune tolerance.
Key Trial Info
Start Date :
September 24 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04675541
Start Date
September 24 2018
End Date
December 31 2024
Last Update
January 8 2025
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Brest
Brest, France
2
CHU Caen
Caen, France
3
CHU Chambéry
Chambéry, France
4
CHU Clermont-Ferrand
Clermont-Ferrand, France