Status:
UNKNOWN
Study of Surgical Practices in Patients With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Hemophilia A
Hemophilia B
Eligibility:
All Genders
Brief Summary
Haemophilia A and haemophilia B are inherited bleeding disorders resulting from the absence or deficiency of coagulation factors VIII and IX, respectively. The peri-operative period of people with hae...
Eligibility Criteria
Inclusion
- patient with Haemophilia A or B
- surgery performed with Elocta® or Alprolix®
- Information leaflet given to the patient who as reached the age of majority or to the parents or legal guardian for minors
Exclusion
- Any blood coagulation disorder other than Haemophilia A or B
- Patient with factor VIII or IX inhibitor
- Severe liver disease (serum ALAT/ASAT levels\> 5 x ULN)
- Severe renal disease (serum creatinine \> 2x ULN)
- Known hypersensitivity to the substances or its excipients
- patient participating in another clinical trial or having participated in another clinical trial within the previous 30 days (non-interventional studies are not a criterion for non-inclusion)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06158334
Start Date
June 1 2022
End Date
December 1 2024
Last Update
December 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre de Référence en Hémophilie, hôpityal Louis Pradel, GHE- Hospices Civils de Lyon
Bron, France