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Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04133883
Acronym
A-MOVE
Enrollment
88
Registered
2019-10-21
Start date
2020-01-13
Completion date
2022-07-13
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

joint health

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.

Interventions

PROCEDUREUltrasound, Haemophilia Joint Health Score

Systematic joint examinations of ankles, knees and elbows

Sponsors

Swedish Orphan Biovitrum
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US12 monthsYes/No

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026