Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination (A-MOVE)

Sobi

Status: Completed

Conditions: Hemophilia A

Treatments: Procedure: Ultrasound, Haemophilia Joint Health Score

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04133883

Sobi.HAEM8-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 6 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

88 participants in 1 patient group

Haemophilia A patients

Other group

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.

Treatment:

Procedure: Ultrasound, Haemophilia Joint Health Score