An interventional study of Joint Ultrasound (HEAD-US) and Blood Sample for Coagulation Factor Measurement in Mild Hemophilia, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Prevention
Currently, few recommendations exist for patients with mild hemophilia, who represent approximately 60% of the hemophilia population. This study aims to provide objective data on joint health in these patients, which are currently limited compared to those with moderate or severe hemophilia.
The use of joint ultrasound in mild hemophilia could allow early, asymptomatic detection of joint damage, support tailored management including patient education, and ultimately improve quality of life.
The study will also explore the correlation between coagulation factor levels (FVIII or FIX) and other indicators of joint health in France.
Hemophilia is an inherited bleeding disorder caused by a deficiency of factor VIII (hemophilia A) or factor IX (hemophilia B), predominantly affecting males, although female carriers can also be symptomatic, often in a milder form. The incidence of hemophilia is similar worldwide, with hemophilia A occurring in approximately 1 in 5,000 births and hemophilia B in 1 in 25,000 births. In France, over 8,000 patients with hemophilia A and 2,000 patients with hemophilia B have been reported, with approximately one-third presenting with severe disease, over 10% with moderate disease, and 60% with mild disease.
Severe hemophilia is associated with frequent and potentially serious bleeding, including joint bleeding, which can lead to progressive and irreversible hemophilic arthropathy. Optimized hemostatic treatments and early detection strategies, such as joint ultrasound, have markedly improved outcomes in severe cases. However, little is known about joint health in patients with mild hemophilia. Although bleeds are less frequent and rarely spontaneous in these patients, they remain at risk of developing arthropathy, including from asymptomatic micro-bleeds.
This study aims to provide objective data on joint health in mild hemophilia patients in France and to explore potential correlations between coagulation factor levels (FVIII or FIX) and other indicators of joint involvement. The results are expected to improve understanding of joint disease in this population and may help guide future preventive and therapeutic strategies.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 150 is above the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion Criteria:
Patient on prophylactic treatment, defined as at least one of the following:
o. ≥5 factor concentrate injections per month for a period of more than 6 months o. Treatment with emicizumab o. Last factor concentrate injection within the past 28 days
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with mild hemophilia will undergo an evaluation of joint health and functional status. Assessments will include joint ultrasound (HEAD-US) of six joints (ankles, knees, and elbows), blood sampling to determine FVIII or FIX activity, completion of functional, quality-of-life, and physical activity questionnaires, and clinical evaluation using the HemoFAST score. No therapeutic intervention or follow-up is planned as part of the study.
Other: Joint Ultrasound (HEAD-US) · Other: Blood Sample for Coagulation Factor Measurement
Ultrasound evaluation of six joints (both ankles, knees, and elbows) by a designated expert using the HEAD-US scoring system to assess joint health and detect early arthropathy.
Blood sample collected according to local laboratory procedures to measure coagulation factor activity (FVIII for hemophilia A, FIX for hemophilia B).
Haemophilia Early Arthropathy Detection with UltraSound (HEAD-US) score
Ultrasound evaluation of six joints (elbows, knees, and ankles) using the HEAD-US scoring system (score range 0-48, where lower scores indicate better joint status) to assess joint health and detect early arthropathy.
Time frame: At inclusion visit
FVIII or FIX Activity
Blood sample measurement of FVIII or FIX activity according to local laboratory procedures (score range 5-40).
Time frame: At inclusion visit
Haemophilia Functional Ability Scoring Tool (Hemo-FAST)
Clinical assessment of joint function using the HemoFAST score performed by the physician or designated representative (score range 0-100, where 0 indicates best joint function and higher scores indicate worse joint function).
Time frame: At inclusion visit
Haemophilia Activities List (HAL)
Patient-reported questionnaire evaluating functional ability using the validated French translation (score range 0-100, with higher scores indicating better function).
Time frame: At inclusion visit
Haemophilia-Associated Quality of Life Questionnaire for Adults (Haem-A-QoL).
Patient-reported questionnaire evaluating quality of life using the validated French translation (score range 0-100, with higher scores indicating poorer quality of life).
Time frame: At inclusion visit
EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L)
Patient-reported questionnaire evaluating health status using the validated French version of the EQ-5D-3L (descriptive system).
Time frame: At inclusion visit
International Physical Activity Questionnaire (IPAQ)
Patient-reported questionnaire assessing physical activity levels using the IPAQ. Scores are derived according to standard IPAQ scoring procedures.
Time frame: At inclusion visit
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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