Clinical trial NCT04133883: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemophilia A
Keywords: joint health
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2019-10-21
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Swedish Orphan Biovitrum Research site
city: Bordeaux
country: France
facility: Swedish Orphan Biovitrum Research site
city: Brest
country: France
facility: Swedish Orphan Biovitrum Research site
city: Caen
country: France
facility: Swedish Orphan Biovitrum Research site
city: Chambéry
country: France
facility: Swedish Orphan Biovitrum Research site
city: Clermont-Ferrand
country: France
facility: Swedish Orphan Biovitrum Research site
city: Dijon
country: France
facility: Swedish Orphan Biovitrum Research site
city: Le Kremlin-Bicêtre
country: France
facility: Swedish Orphan Biovitrum Research site
city: Lyon
country: France
facility: Swedish Orphan Biovitrum Research site
city: Marseille
country: France
facility: Swedish Orphan Biovitrum Research site
city: Montpellier
country: France
facility: Swedish Orphan Biovitrum Research site
city: Nancy
country: France
facility: Swedish Orphan Biovitrum Research site
city: Nantes
country: France
facility: Swedish Orphan Biovitrum Research site
city: Paris
country: France
facility: Swedish Orphan Biovitrum Reserach site
city: Poitiers
country: France
facility: Swedish Orphan Biovitrum Research site
city: Reims
country: France
facility: Swedish Orphan Biovitrum Research site
city: Rouen
country: France
facility: Swedish Orphan Biovitrum Research site
city: Strasbourg
country: France
facility: Swedish Orphan Biovitrum Research site
city: Toulouse
country: France
facility: Swedish Orphan Biovitrum Research site
city: Tours
country: France
facility: Swedish Orphan Biovitrum Research Site
Study officials:
affiliation: Swedish Orphan Biovitrum
name: Elena Santagostino
role: STUDY_DIRECTOR
References: