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

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ClinicalTrials.gov Identifier: NCT04133883
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Kantar Health
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hemophilia A Procedure: Ultrasound, Haemophilia Joint Health Score Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Estimated Study Start Date : November 15, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133883


Contacts
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Contact: Sofia Bergenstråle +46 8 697 2000 sofia.bergenstrale@sobi.com

Sponsors and Collaborators
Swedish Orphan Biovitrum
Kantar Health
Investigators
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Study Director: Stefan Lethagen Swedish Orphan Biovitrum

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Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT04133883     History of Changes
Other Study ID Numbers: Sobi.HAEM8-001
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swedish Orphan Biovitrum:
joint health
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn