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®)

Hemophilia A Clinical Trial

— CHALE  

Official title:

Study of Surgical Practices in Patient With Haemophilia A or B Treated With an Extended Half-life Recombinant Factor VIII-Fc or IX-Fc (ELOCTA®, ALPROLIX®)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158334
• Other study ID #: 868
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Hospices Civils de Lyon
• Contact: Anne LIEHNART, MD
• Phone: +33 4 72 11 88 10
• Email: anne.lienhart[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 haemophilia is commonly managed with replacement therapy.

In phase 3 studies of Elocta® (extended half-life recombinant factor VIII-Fc) and Alprolix® (extended half-life recombinant factor IX-Fc), haemostatic efficacy was demonstrated to be good or excellent, close to the haemostatic efficacy usually seen in people without haemophilia, with maintenance and stability of circulating FVIII and FIX levels compatible with the surgical procedure, while reducing the frequency of infusions and consumption of therapeutic units. In 2019, the National Protocol for Diagnosis and Care in haemophilia recommended 2 methods for managing patients with haemophilia in the peri-operative period, either discontinuous injections of standard or extended half-life factor VIII/IX or a continuous infusion of FVIII/IX.

Many countries, including France, have adopted these rFVIII/IXFc therapeuitic products and recommended their use in the surgical management of patients. However, the use of these two products in real life during surgery in haemophilic A and B patients has not been described in detail. It seems therefore relevant to better document their use in order to progressively specify their use during surgeries with varied bleeding risks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Hemophilia A
• Hemophilia B

Intervention

Drug:
• Describe the respective haemostatic efficacy of Elocta® for haemopilia A during surgical procedures
All surgical data will be collected: surgery, biology, administration of Elocta®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding
• Describe the respective haemostatic efficacy of Alprolix® for haemopilia B during surgical procedures
All surgical data will be collected: surgery, biology, administration of Alprolix®, bleeding and transfusion, hemostatic efficacity, surgery complication and bleeding…

Locations

Country	Name	City	State
France	Centre de Référence en Hémophilie, hôpityal Louis Pradel, GHE- Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative haemostatic efficacy described in real life with ELOCTA® and ALPROLIX® in haemophilia A and B patients. Haemostatic efficacy is defined by excellent, good, fair, poor.	changes in hemostatic efficacy between surgery and 15 days post-surgery	15 days post-surgery