Status:
COMPLETED
Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Hemophilia A
Eligibility:
All Genders
6-40 years
Phase:
NA
Brief Summary
This low interventional study aims to describe if and how the haemophilia treatment management decisions are impacted by a systematic joint examination (ultrasound, functional, physical) in patients w...
Detailed Description
The study will assess the behavior of the physicians with regards to haemophilia management decisions, and if systematic joint examination have an impact on their decisions. The main objective is to e...
Eligibility Criteria
Inclusion
- Age 6-40 years
- Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII)
- At least one joint bleeding episode prior to inclusion
- Signed informed consent
Exclusion
- Enrolment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product, within three months prior to inclusion in the study
- Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit \[BU\]/mL) at the latest available inhibitor test
- Joint surgery over the past year prior to inclusion in one of the following joints; left knee, right knee, left elbow, right elbow, left ankle and right ankle
- More than one joint replacement
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04133883
Start Date
January 13 2020
End Date
July 13 2022
Last Update
September 19 2024
Active Locations (20)
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1
Swedish Orphan Biovitrum Research site
Angers, France
2
Swedish Orphan Biovitrum Research site
Bordeaux, France
3
Swedish Orphan Biovitrum Research site
Brest, France
4
Swedish Orphan Biovitrum Research site
Caen, France