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®)
NCT ID: NCT06158334
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2022-06-01
2024-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Minor and major surgeries of patients with haemophilia A treated with Elocta®
Description of all surgical data (minor and major) on Elocta® (all dosage and treatment regimens)
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
Minor and major surgeries of patients with haemophilia B treated with Alprolix®
Description of all surgical data (minor and major) on Alprolix® (all dosage and treatment regimens)
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…
Interventions
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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…
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Centre de Référence en Hémophilie, hôpityal Louis Pradel, GHE- Hospices Civils de Lyon
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Anne LIENHART, MD
Role: primary
Other Identifiers
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868
Identifier Type: -
Identifier Source: org_study_id