Brief Title
Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination
Official Title
A Study to Investigate if the Use of a Systematic Joint Examination (Ultrasound/Functional/Physical) Has an Impact on the Physician's Haemophilia Treatment Management Decision in Patients With Haemophilia
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 with haemophilia A in France.
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 evaluate if the use of HEAD-US and Haemophilia Joint Health Score (HJHS) have an impact on these decisions. The study is classified as a low-interventional study due to mandated systematically assessment (HEAD-US, HJHS) on patients which may not be part of routine clinical practice.
Study Type
Interventional
Primary Outcome
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
Condition
Hemophilia A
Intervention
Ultrasound, Haemophilia Joint Health Score
Study Arms / Comparison Groups
Haemophilia A patients
Description: Treated on-demand or prophylaxis with any Factor VIII (FVIII) product, plasma derived or recombinant (conventional or extended-half life) FVIII, according to routine clinical practice.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
88
Start Date
January 13, 2020
Completion Date
July 13, 2022
Primary Completion Date
July 13, 2022
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
6 Years - 40 Years
Accepts Healthy Volunteers
No
Contacts
Elena Santagostino, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04133883
Organization ID
Sobi.HAEM8-001
Responsible Party
Sponsor
Study Sponsor
Swedish Orphan Biovitrum
Collaborators
Cerner Enviza
Study Sponsor
Elena Santagostino, Study Director, Swedish Orphan Biovitrum
Verification Date
January 2023