NCT04133883|Completed

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

A-MOVE

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

Swedish Orphan Biovitrum ClinicalTrials.gov

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1 other identifier

Sobi.HAEM8-001

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredOct 2019

StartedJan 2020

CompletionJul 2022

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

October 18, 2019

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed

3 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2022

Completed

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.5 years

First QC Date

October 18, 2019

Last Update Submit

September 17, 2024

Conditions

Hemophilia A

Keywords

joint health

Outcome Measures

Primary Outcomes (1)

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

Study Arms (1)

Haemophilia A patients

OTHER

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

Interventions

Ultrasound, Haemophilia Joint Health ScorePROCEDURE

Systematic joint examinations of ankles, knees and elbows

Haemophilia A patients

Eligibility Criteria

Age6 Years - 40 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Age 6-40 years
Haemophilia A patients treated with plasma-derived factor VIII (pdFVIII) or recombinant (conventional or extended half-life) factor VIII (rFVIII)
Signed informed consent

You may not qualify if:

Presence of factor VIII antibodies (inhibitors) (≥0.60 Bethesda Unit \[BU\]/mL) at the latest available inhibitor test
More than one joint replacement

Contact the study team to confirm eligibility.