Hemophilia AA-MOVENCT04133883
Impact on French Physician's Haemophilia Treatment Management Decision Based on Systematic Joint Examination
A study testing Ultrasound, Haemophilia Joint Health Score in people with Hemophilia A, run by Swedish Orphan Biovitrum at 20 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Ultrasound, Haemophilia Joint Health Score
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 20 sitesFrance
- Study dates
- 13 Jan 2020to 13 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Swedish Orphan Biovitrum Research site
Angers
Swedish Orphan Biovitrum Research site
Bordeaux
Swedish Orphan Biovitrum Research site
Brest
Swedish Orphan Biovitrum Research site
Caen
Swedish Orphan Biovitrum Research site
Chambéry
Swedish Orphan Biovitrum Research site
Clermont-Ferrand
Swedish Orphan Biovitrum Research site
Dijon
Swedish Orphan Biovitrum Research site
Le Kremlin-Bicêtre
Swedish Orphan Biovitrum Research site
Lyon
Swedish Orphan Biovitrum Research site
Marseille
Swedish Orphan Biovitrum Research site
Montpellier
Swedish Orphan Biovitrum Research site
Nancy
Swedish Orphan Biovitrum Research site
Nantes
Swedish Orphan Biovitrum Reserach site
Paris
Swedish Orphan Biovitrum Research site
Poitiers
Swedish Orphan Biovitrum Research site
Reims
Swedish Orphan Biovitrum Research site
Rouen
Swedish Orphan Biovitrum Research site
Strasbourg
Swedish Orphan Biovitrum Research site
Toulouse
Swedish Orphan Biovitrum Research Site
Tours
About this study
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
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.
Read the 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.
- Conditions
- Hemophilia A
- Being tested
- Ultrasound, Haemophilia Joint Health Score
- Keywords
- joint health
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound, Haemophilia Joint Health ScoreProcedure or surgery
Systematic joint examinations of ankles, knees and elbows
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Ultrasound, Haemophilia Joint Health Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US
Yes/No
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2019
- Study start13 Jan 2020
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Santagostino, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04133883
- Sponsor's protocol ID
- Sobi.HAEM8-001
- Acronym
- A-MOVE
- Status last verified
- Sep 2024
- First submitted
- 18 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04133883
- Acronym / sponsor ID
- A-MOVE / Sobi.HAEM8-001
- Conditions
- Hemophilia A
- Keywords
- joint health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 21 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Haemophilia A patients | Other | Procedure: Ultrasound, Haemophilia Joint Health ScoreTreated 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. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound, Haemophilia Joint Health ScoreSystematic joint examinations of ankles, knees and elbows | Procedure or surgery | Haemophilia A patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Santagostino study director
Swedish Orphan Biovitrum
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Haemophilia Joint Health Score in people with Hemophilia A, run by Swedish Orphan Biovitrum at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in haemophilia management based on systematic joint examinations of ankles, knees and elbows with HJHS and HEAD-US (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.