Ultrasound Assessment of Joint Health in Patients With Mild Hemophilia (Factor Levels 5-40%)

Condition(s) studied

Investigational drug(s) / intervention(s)

Joint Ultrasound (HEAD-US): 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 for Coagulation Factor Measurement: Blood sample collected according to local laboratory procedures to measure coagulation factor activity (FVIII for hemophilia A, FIX for hemophilia B).

Study summary

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.

Eligibility

Primary outcome measure(s)

• Haemophilia Early Arthropathy Detection with UltraSound (HEAD-US) score — At inclusion visit
  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.
• FVIII or FIX Activity — At inclusion visit
  Blood sample measurement of FVIII or FIX activity according to local laboratory procedures (score range 5-40).

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France