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

NCT ID: NCT04133883

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2022-07-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hemophilia A

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Haemophilia A patients

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.

Group Type OTHER

Ultrasound, Haemophilia Joint Health Score

Intervention Type PROCEDURE

Systematic joint examinations of ankles, knees and elbows

Interventions

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Ultrasound, Haemophilia Joint Health Score

Systematic joint examinations of ankles, knees and elbows

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elena Santagostino

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum

Locations

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Swedish Orphan Biovitrum Research site

Angers, , France

Site Status

Swedish Orphan Biovitrum Research site

Bordeaux, , France

Site Status

Swedish Orphan Biovitrum Research site

Brest, , France

Site Status

Swedish Orphan Biovitrum Research site

Caen, , France

Site Status

Swedish Orphan Biovitrum Research site

Chambéry, , France

Site Status

Swedish Orphan Biovitrum Research site

Clermont-Ferrand, , France

Site Status

Swedish Orphan Biovitrum Research site

Dijon, , France

Site Status

Swedish Orphan Biovitrum Research site

Le Kremlin-Bicêtre, , France

Site Status

Swedish Orphan Biovitrum Research site

Lyon, , France

Site Status

Swedish Orphan Biovitrum Research site

Marseille, , France

Site Status

Swedish Orphan Biovitrum Research site

Montpellier, , France

Site Status

Swedish Orphan Biovitrum Research site

Nancy, , France

Site Status

Swedish Orphan Biovitrum Research site

Nantes, , France

Site Status

Swedish Orphan Biovitrum Reserach site

Paris, , France

Site Status

Swedish Orphan Biovitrum Research site

Poitiers, , France

Site Status

Swedish Orphan Biovitrum Research site

Reims, , France

Site Status

Swedish Orphan Biovitrum Research site

Rouen, , France

Site Status

Swedish Orphan Biovitrum Research site

Strasbourg, , France

Site Status

Swedish Orphan Biovitrum Research site

Toulouse, , France

Site Status

Swedish Orphan Biovitrum Research Site

Tours, , France

Site Status

Countries

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France

Other Identifiers

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Sobi.HAEM8-001

Identifier Type: -

Identifier Source: org_study_id

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