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

Not Applicable

Completed

• Conditions: Hemophilia A
• Interventions: Procedure: Ultrasound, Haemophilia Joint Health Score

• Registration Number: NCT04133883
• Lead Sponsor: Swedish Orphan Biovitrum

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 Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-18
• Study First Posted: 2019-10-21
• Study Start: 2020-01-13
• Primary Completion: 2022-07-13
• Study Completion: 2022-07-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Haemophilia A patients	Ultrasound, Haemophilia Joint Health Score	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.

Primary Outcome Measures

Name	Time	Method
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US	12 months	Yes/No

Trial Locations

Locations (3)

Swedish Orphan Biovitrum Reserach site; 🇫🇷 Paris, France

Swedish Orphan Biovitrum Research Site; 🇫🇷 Tours, France

Swedish Orphan Biovitrum Research site; 🇫🇷 Toulouse, France