A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa
NCT ID: NCT05817812
Last Updated: 2025-10-09
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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ACTIVE_NOT_RECRUITING
PHASE3
93 participants
INTERVENTIONAL
2023-07-31
2026-06-12
Brief Summary
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The primary objective is to describe changes in physical activities over 24 months on efanesoctocog alfa prophylaxis, with a primary endpoint of change from baseline in International Physical Activity Questionnaire (IPAQ) at month 24.
Secondary objectives include relationship between physical activity and other variables (bleeds, joint status, pain, injuries, and quality of life); changes in joint status as assessed by HEAD-US, HJHS and MRI; occurrence of bleeds, injuries, pain. Safety and tolerability of efanesoctocog alfa will also be evaluated.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Efanesoctocog alfa
All patients will be treated intravenously once weekly with 50 IU/kg efanesoctocog alfa
Efanesoctocog alfa
Recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN)
Interventions
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Efanesoctocog alfa
Recombinant coagulation factor VIII Fc-von Willebrand Factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having received prophylactic treatment with any marketed recombinant and/or plasma FVIII or emicizumab per local label for at least 12 months preceding enrolment.
* Having 12 months documented pre-study treatment data regarding prophylactic treatment prescriptions and 6 months data on bleeding episodes prior to baseline visit.
* Willingness and ability to complete training in the use of the study ePD and to use the ePD in their own smartphone throughout the study.
* Willingness and ability to use the activity tracker provided by the sponsor to measure physical activity and heart rate.
* Be able and willing to administer efanesoctocog alfa intravenously at home.
Exclusion Criteria
* Other known coagulation disorder(s) in addition to haemophilia A.
* History and/or current positive inhibitor test defined as ≥0.6 BU/mL.
* Treatment with NSAIDs above the maximum dose specified in the prescribing information within 2 weeks prior to screening.
* Systematic treatment within 12 weeks prior to screening with chemotherapy and/or other immunosuppressive drugs.
* Treatment with an investigational product within 30 days or 5.5 half-lives prior to screening, whichever is longer.
* Major surgery within 12 weeks prior to screening or planned major orthopaedic surgery to occur during the study.
* At baseline visit, patients who have not been compliant in using the activity tracker.
12 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Swedish Orphan Biovitrum
INDUSTRY
Responsible Party
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Principal Investigators
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Study Physician, MD, PhD
Role: STUDY_DIRECTOR
Swedish Orphan Biovitrum AB
Locations
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Investigational Site
Lund, , Sweden
Investigational Site
Solna, , Sweden
Investigational Site
Canterbury, , United Kingdom
Investigational Site
Newcastle upon Tyne, , United Kingdom
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Oxford, , United Kingdom
Investigational Site
Vienna, , Austria
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Zagreb, , Croatia
Investigational Site
Brno, , Czechia
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Prague, , Czechia
Investigational Site
Bordeaux, , France
Investigational Site
Le Kremlin-Bicêtre, , France
Investigational Site
Marseille, , France
Investigational Site
Strasbourg, , France
Investigational Site
Berlin, , Germany
Investigational Site
Frankfurt, , Germany
Investigational Site
Giessen, , Germany
Investigational Site
Hamburg, , Germany
Investigational Site
Athens, , Greece
Investigational Site
Dublin, , Ireland
Investigational Site
Catanzaro, , Italy
Investigational Site
Florence, , Italy
Investigational Site
Naples, , Italy
Investigational Site
Parma, , Italy
Investigational Site
Rome, , Italy
Investigational Site
Utrecht, , Netherlands
Investigational Site
Oslo, , Norway
Investigational Site
Ljubljana, , Slovenia
Investigational Site
Barcelona, , Spain
Investigational Site
Madrid, , Spain
Investigational Site
Oviedo, , Spain
Countries
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Other Identifiers
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Sobi.BIVV001-001
Identifier Type: -
Identifier Source: org_study_id
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