Watching for joint damage on ultrasound in hemophilia A patients treated with emicizumab
Follows joint health over time in people with hemophilia A using emicizumab.
Plain-language title generated from the registry record
Registry title: Incidence of Ultrasonographically Detected Articular Damage in Initially Healthy Joints of Patients With Hemophilia A Receiving Prophylactic Treatment With Emicizumab
Key facts
- Where
- Oviedo, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with hemophilia A, aged 10 or older, who get emicizumab as routine prevention and have at least one healthy elbow, knee or ankle.
- Age
- 10 years or older
- Sex
- Males only
- Disease stage
- Confirmed hemophilia A. At least one elbow, knee or ankle with no joint damage on ultrasound (HEAD-US = 0) at the start.
- Earlier treatment
- Must be getting emicizumab (Hemlibra®) as routine preventive treatment. No clearly visible joint bleed in the joint studied since starting emicizumab.
Main reasons for not taking part
- Joint damage on ultrasound (HEAD-US ≥1) in all joints checked
- Past clearly visible joint bleeding in the joints studied
- Major orthopedic surgery or joint replacement in the joints studied
- Another bone or muscle disease not caused by hemophilia that could affect the joint checks
- Cannot complete the planned 24-month follow-up
Read by machine on 9 November 2026.
Where in Spain
- Universidad de OviedoOviedo, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Investigación en Hemofilia y Fisioterapia
- Trial code
- NCT07420348
- Record updated
- 20 February 2026
- Original description
Introduction: Prophylaxis with emicizumab has substantially improved hemorrhagic control in hemophilia A. However, the longitudinal incidence of ultrasonographically detected articular damage in initially healthy joints remains insufficiently characterized.Read full original descriptionShow less
Incidence of Ultrasonographically Detected Articular Damage in Initially Healthy Joints of Patients With Hemophilia A Receiving Prophylactic Treatment With Emicizumab. A Prospective Observational Study
Introduction: Prophylaxis with emicizumab has substantially improved hemorrhagic control in hemophilia A. However, the longitudinal incidence of ultrasonographically detected articular damage in initially healthy joints remains insufficiently characterized.
Objective: To estimate the incidence of ultrasonographically detected articular damage in initially healthy joints among patients with hemophilia A receiving prophylaxis with emicizumab and to explore its association with relevant clinical variables.
Methods: A prospective, longitudinal, observational study will be conducted in approximately 70 patients with hemophilia A receiving emicizumab, with an estimated recruitment of approximately 270 initially healthy joints. The study is purely observational and does not involve evaluation of the investigational product nor modification of the therapeutic regimen; dosing, administration intervals, and all clinical decisions regarding emicizumab will be determined exclusively at the discretion of the treating hematologist. Assessments will be performed at baseline and at 12 and 24 months. The unit of analysis will be the joint, including elbows, knees, and ankles without ultrasonographic evidence of articular damage and without a history of clinically evident hemarthrosis at study entry.
The primary endpoint will be the occurrence of incident ultrasonographically detected articular damage, assessed using the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol. Secondary outcomes will include clinical joint health assessed by the Hemophilia Joint Health Score (HJHS), version 2.1; the frequency of joint hemarthroses measured by the annualized joint bleeding rate (AJBR); and habitual physical activity levels evaluated through age-specific validated questionnaires. Statistical analyses will account for intra-patient correlation among joints.
Expected Results: A low to moderate incidence of ultrasonographically detected articular damage in initially healthy joints is anticipated during follow-up, providing clinically relevant information regarding structural joint preservation in patients with hemophilia A receiving emicizumab prophylaxis.
Inclusion: Confirmed diagnosis of hemophilia A; Receiving prophylactic treatment with emicizumab (Hemlibra®) according to routine clinical practice; Age ≥10 years at the time of study enrollment; Absence of ultrasonographic joint damage in at least one of the evaluated joints (elbows, knees, or ankles), defined as HEAD-US = 0 at baseline assessment; No documented history of clinically evident hemarthrosis in the corresponding joints from initiation of emicizumab prophylaxis to the study baseline evaluation; Ability to understand and complete study procedures (interviews, questionnaires, and clinical assessments), in accordance with the participant's age; and; Provision of written informed consent; for minors, written informed consent from parents or legal guardians and assent from the minor participant, in accordance with applicable regulations.
Exclusion: Prior major orthopedic surgery or arthroplasty in the evaluated joints; Presence of concomitant musculoskeletal pathology unrelated to hemophilia that could interfere with joint assessment (e.g., inflammatory arthritis, recent severe trauma); Concurrent participation in another interventional study that could interfere with the joint health variables under evaluation; and; Documented history of clinically evident hemarthrosis in the joints under study; Any clinical or social condition that, in the investigator's judgment, could compromise participant safety or the validity of the study data; Presence of ultrasonographic joint damage (HEAD-US ≥1) in all evaluated joints at the baseline visit; Inability to complete the planned 24-month follow-up or to undergo study assessments.