Hemophilia AHemo-FASTNCT04731701
Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
An observational study of Hemophilia A and Hemophilia B, run by Swedish Orphan Biovitrum at 16 sites in France.
Trial summary
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Hemophilia Joint Health Score (HJHS)
- How many people
- 180 participants
- Where
- 16 sitesFrance
- Study dates
- 5 May 2021to 19 Jul 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled from 10-15 haemophilia treatment centres (HTCs) across France. The lower age limit of 18 years has been chosen because Hemo-FAST was developed to be used among the adult population. Age is an important contributor to the development of joint damage. Enrolment will therefore be targeted so that there will be similar numbers of patients enrolled across three age groups: 18-29, 30-44 and ≥ 45-years old.
Who may be able to join
None listed.
Who cannot join
- The presence of any of the following criteria will exclude a patient from inclusion in the study:
- Joint replacement within last 6 months.
- Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit.
- Patients with comorbid illnesses such as juvenile arthritis, muscular dystrophy, neurologic illness/cognitive impairment, or other illnesses that may independently affect HJHS and Hemo-FAST scores and/or limit the ability of the patient to participate in the study as determined by the investigator.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Swedish Orphan Biovitrum Clinical site
Besançon
Swedish Orphan Biovitrum Clinical site
Bordeaux
Swedish Orphan Biovitrum Clinical site
Brest
Swedish Orphan Biovitrum Clinical site
Caen
Swedish Orphan Biovitrum Clinical site
Clermont-Ferrand
Swedish Orphan Biovitrum Clinical site
Dijon
Swedish Orphan Biovitrum Clinical site
Lyon
Swedish Orphan Biovitrum Clinical site
Marseille
Swedish Orphan Biovitrum Clinical site
Nancy
Swedish Orphan Biovitrum Clinical site
Nantes
Swedish Orphan Biovitrum Clinical site
Paris, Cochin
Swedish Orphan Biovitrum Clinical site
Paris, Kremlin-Bicêtre
Swedish Orphan Biovitrum Clinical site
Rouen
Swedish Orphan Biovitrum Clinical site
Saint-Etienne
Swedish Orphan Biovitrum Clinical site
Strasbourg
Swedish Orphan Biovitrum Clinical site
Toulouse
About this study
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.
Read the detailed description
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility for adult haemophilia patients.
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- Hemophilia Joint Health Score (HJHS)
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemophilia Joint Health Score (HJHS)Diagnostic test
Joint examination with Hemophilia Joint Health Score (HJHS)
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST).
Statistical analysis to confirm the psychometric validation of the Hemo-FAST questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start5 May 2021
- Primary completion19 Jul 2022
- Study completion19 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kantar Health, Cerner Enviza (former Kantar Health)
- Responsible party
- Sponsor
- Investigators
- Study Physician, Study director, Swedish Orphan Biovitrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731701
- Sponsor's protocol ID
- Sobi.HAEM89-005
- Acronym
- Hemo-FAST
- Status last verified
- Sep 2024
- First submitted
- 24 Nov 2020
- 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
- Psychometric Validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST)
- ClinicalTrials.gov ID
- NCT04731701
- Acronym / sponsor ID
- Hemo-FAST / Sobi.HAEM89-005
- Conditions
- Hemophilia A, Hemophilia B
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- Kantar Health, Cerner Enviza (former Kantar Health)
- Study start
- 5 May 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 1 Feb 2021 (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.
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility.
Detailed description
The purpose of this study is to validate the newly developed Hemophilia Functional Ability Scoring Tool (Hemo-FAST), which is a fast and simple scoring in haemophilia able to assess patient-reported functional mobility for adult haemophilia patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled from 10-15 haemophilia treatment centres (HTCs) across France. The lower age limit of 18 years has been chosen because Hemo-FAST was developed to be used among the adult population. Age is an important contributor to the development of joint damage. Enrolment will therefore be targeted so that there will be similar numbers of patients enrolled across three age groups: 18-29, 30-44 and ≥ 45-years old.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- The presence of any of the following criteria will exclude a patient from inclusion in the study:
- Joint replacement within last 6 months.
- Patients with a non-resolved joint or muscle bleeding event at the enrolment visit or ≤ 7 days prior to the enrolment visit.
- Patients with comorbid illnesses such as juvenile arthritis, muscular dystrophy, neurologic illness/cognitive impairment, or other illnesses that may independently affect HJHS and Hemo-FAST scores and/or limit the ability of the patient to participate in the study as determined by the investigator.
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 |
|---|---|---|
| Hemophilia Joint Health Score (HJHS)Joint examination with Hemophilia Joint Health Score (HJHS) | Diagnostic test | – |
Primary outcome
Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST).
Time frame: Baseline
Statistical analysis to confirm the psychometric validation of the Hemo-FAST questionnaire
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.
Study Physician study director
Swedish Orphan Biovitrum
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A and Hemophilia B, run by Swedish Orphan Biovitrum at 16 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 0 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 16 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?
Psychometric validation of the Hemophilia Functional Ability Scoring Tool (Hemo-FAST). (time frame: Baseline). 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.