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

September 17, 2024 updated by: Swedish Orphan Biovitrum

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Swedish Orphan Biovitrum Research site
      • Bordeaux, France
        • Swedish Orphan Biovitrum Research site
      • Brest, France
        • Swedish Orphan Biovitrum Research site
      • Caen, France
        • Swedish Orphan Biovitrum Research site
      • Chambéry, France
        • Swedish Orphan Biovitrum Research site
      • Clermont-Ferrand, France
        • Swedish Orphan Biovitrum Research site
      • Dijon, France
        • Swedish Orphan Biovitrum Research site
      • Le Kremlin-Bicêtre, France
        • Swedish Orphan Biovitrum Research site
      • Lyon, France
        • Swedish Orphan Biovitrum Research site
      • Marseille, France
        • Swedish Orphan Biovitrum Research site
      • Montpellier, France
        • Swedish Orphan Biovitrum Research site
      • Nancy, France
        • Swedish Orphan Biovitrum Research site
      • Nantes, France
        • Swedish Orphan Biovitrum Research site
      • Paris, France
        • Swedish Orphan Biovitrum Reserach site
      • Poitiers, France
        • Swedish Orphan Biovitrum Research site
      • Reims, France
        • Swedish Orphan Biovitrum Research site
      • Rouen, France
        • Swedish Orphan Biovitrum Research site
      • Strasbourg, France
        • Swedish Orphan Biovitrum Research site
      • Toulouse, France
        • Swedish Orphan Biovitrum Research site
      • Tours, France
        • Swedish Orphan Biovitrum Research site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Procedure: Ultrasound, Haemophilia Joint Health Score
Systematic joint examinations of ankles, knees and elbows

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
Time Frame: 12 months
Yes/No
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Orphan Biovitrum

Collaborators

Cerner Enviza

Investigators

  • Study Director: Elena Santagostino, Swedish Orphan Biovitrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

July 13, 2022

Study Completion (Actual)

July 13, 2022

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 17, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sobi.HAEM8-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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