HemophiliaNCT07420348

Incidence of Ultrasonographically Detected Articular Damage in Initially Healthy Joints of Patients With Hemophilia A Receiving Prophylactic Treatment With Emicizumab

An observational study of Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

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 more about this study

Who is it for?: Ages 10 years and older, men only
Conditions the study is for: Hemophilia
What is being tested?: Hemophilia patients
How many people: 70 participants
Where: 1 siteSpain
Study dates: 27 Feb 2026to 3 May 2028
Phase: Observational
Are there results?: Not yet: the study is under way

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 10 years and older
Men only
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with hemophilia A receiving prophylactic treatment with emicizumab

Who may be able to join

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.

Who cannot join

Presence of ultrasonographic joint damage (HEAD-US ≥1) in all evaluated joints at the baseline visit;
Documented history of clinically evident hemarthrosis in the joints under study;
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);
Inability to complete the planned 24-month follow-up or to undergo study assessments;
Concurrent participation in another interventional study that could interfere with the joint health variables under evaluation; and
Any clinical or social condition that, in the investigator's judgment, could compromise participant safety or the validity of the study data.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rubén Cuesta-Barriuso, PhD contact

0034 985103386

cuestaruben@uniovi.es

Spain1 site

Universidad de Oviedo
Oviedo, Principality of Asturias, 33006
Rubén Cuesta-Barriuso, PhD, 0034 985 103 386, cuestaruben@uniovi.es

Other trials in Spain

About this study

Official title: Incidence of Ultrasonographically Detected Articular Damage in Initially Healthy Joints of Patients With Hemophilia A Receiving Prophylactic Treatment With Emicizumab. A Prospective Observational Study

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.

Conditions: Hemophilia
Being tested: Hemophilia patients
Keywords: Joint damage, emicizumab, prophylaxis, joint preservation
Medical subject headings: Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hemophilia patientsOther
A prospective, longitudinal, observational study will be conducted in patients with hemophilia A receiving prophylaxis with emicizumab, with a 24-month follow-up period. Three assessments will be performed: at baseline, 12 months, and 24 months.

Study groups in NCT07420348
Study group	Role	What they receive
Observational group		Patients with hemophilia A receiving prophylactic treatment with emicizumab Receives: Other: Hemophilia patients

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of Ultrasonographically Detected Articular Damage in Elbows, Knees, and Ankles
Ultrasonographically detected articular damage will be assessed using the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol through standardized musculoskeletal ultrasound examination. This scoring system evaluates three structural domains per joint: synovial (hypertrophy and effusion), cartilage, and bone. Each joint is assigned an ordinal score ranging from 0 (no abnormalities) to a maximum of 8 points, derived from the combined assessment of the synovial, cartilaginous, and osseous domains. The HEAD-US protocol enables detection of subclinical joint damage and early structural changes, even in the absence of clinically evident hemarthrosis.Scree
Measured: Baseline visit, at 12 months, and at 24 months.

Secondary outcomes (5)

Measurement of Clinical Joint Health in Knees, Ankles, and Elbows
Clinical joint health will be assessed using the Hemophilia Joint Health Score, version 2.1 (HJHS 2.1). This instrument evaluates eight items per joint: swelling (edema), duration of swelling, pain, muscle atrophy, crepitus, strength deficit, loss of range of motion, and joint deformity. Additionally, it includes a global gait assessment scored from 0 to 4. Each item is rated on an ordinal scale according to the instrument's predefined criteria, yielding a per-joint score ranging from 0 to 20 and a total score ranging from 0 to 124. Higher scores indicate worse clinical joint health.
Measured: Baseline visit, at 12 months, and at 24 months.
Measurement of Joint Hemorrhagic Phenotype
This variable will be assessed using the Annualized Joint Bleeding Rate (AJBR), calculated as the number of hemarthroses occurring during the observation period divided by the total days of follow-up and multiplied by 365.25. The AJBR will be calculated both globally and on a per-joint basis, based on systematically recorded bleeding events obtained through structured clinical interviews.
Measured: Baseline visit, at 12 months, and at 24 months.
Measurement of Physical Activity Level in patients under 18 years of age
This variable will be assessed using the Physical Activity Questionnaire for Adolescents (PAQ-A). The PAQ-A consists of nine items evaluating participation in various types of physical and sports activities; frequency of activity during physical education classes; activity during recess and leisure time; after-school activity; weekend activity; and overall level of habitual physical activity. Each item is scored on a 5-point Likert scale (1 to 5), and the final score corresponds to the mean of all items. Higher scores indicate a greater level of habitual physical activity.
Measured: Baseline visit, at 12 months, and at 24 months.
Measurement of Physical Activity Level in Adult Patients
This variable will be assessed using the International Physical Activity Questionnaire - Long Form (IPAQ-LF). The IPAQ-LF captures physical activity across four domains: work-related physical activity, active transportation, domestic and household activities, and leisure-time physical activity. Within each domain, the time spent in vigorous-intensity activity, moderate-intensity activity, and walking is recorded, allowing for the calculation of total energy expenditure expressed in MET-minutes per week (MET-min/week).
Measured: Baseline visit, at 12 months, and at 24 months.
Measurement of Treatment Adherence
This variable will be assessed using the Torres questionnaire for treatment adherence in hemophilia. This hemophilia-specific instrument evaluates five dimensions: disease awareness, perceived sequelae, treatment-related difficulties, physician-patient relationship, and hemorrhagic processes. Higher scores indicate greater adherence within the corresponding domain.
Measured: Baseline visit, at 12 months, and at 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 20263 May 2028

First posted19 Feb 2026
Study start27 Feb 2026 (estimated)
Primary completion3 May 2026 (estimated)
Study completion3 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HemophiliaStudies of the same condition, open and under way.
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: Prospective
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07420348
Sponsor's protocol ID: HEmoJoint
Status last verified: Feb 2026
First submitted: 12 Feb 2026
Last updated: 20 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Rubén Cuesta-Barriuso, PhD

0034 985103386

cuestaruben@uniovi.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

All Hemophilia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Incidence of Ultrasonographically Detected Articular Damage in Initially Healthy Joints of Patients With Hemophilia A Receiving Prophylactic Treatment With Emicizumab. A Prospective Observational Study
ClinicalTrials.gov ID: NCT07420348
Acronym / sponsor ID: HEmoJoint
Conditions: Hemophilia
Keywords: Joint damage, emicizumab, prophylaxis, joint preservation
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: Investigación en Hemofilia y FisioterapiaResearch network
Study start: 27 Feb 2026 (estimated)
Primary completion: 3 May 2026 (estimated)
Study completion: 3 May 2028 (estimated)
First posted: 19 Feb 2026 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Observational group	–	Other: Hemophilia patientsPatients with hemophilia A receiving prophylactic treatment with emicizumab

Who may qualify

Ages: 10 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with hemophilia A receiving prophylactic treatment with emicizumab

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (7 listed)

Presence of ultrasonographic joint damage (HEAD-US ≥1) in all evaluated joints at the baseline visit;
Documented history of clinically evident hemarthrosis in the joints under study;
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);
Inability to complete the planned 24-month follow-up or to undergo study assessments;

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 patientsA prospective, longitudinal, observational study will be conducted in patients with hemophilia A receiving prophylaxis with emicizumab, with a 24-month follow-up period. Three assessments will be performed: at baseline, 12 months, and 24 months.	Other	Observational group

Primary outcome

Measurement of Ultrasonographically Detected Articular Damage in Elbows, Knees, and Ankles
Time frame: Baseline visit, at 12 months, and at 24 months.
Ultrasonographically detected articular damage will be assessed using the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) protocol through standardized musculoskeletal ultrasound examination. This scoring system evaluates three structural domains per joint: synovial (hypertrophy and effusion), cartilage, and bone. Each joint is assigned an ordinal score ranging from 0 (no abnormalities) to a maximum of 8 points, derived from the combined assessment of the synovial, cartilaginous, and osseous domains. The HEAD-US protocol enables detection of subclinical joint damage and early structural changes, even in the absence of clinically evident hemarthrosis.Scree

5 secondary outcomes

Measurement of Clinical Joint Health in Knees, Ankles, and Elbows
Time frame: Baseline visit, at 12 months, and at 24 months.
Measurement of Joint Hemorrhagic Phenotype
Time frame: Baseline visit, at 12 months, and at 24 months.
Measurement of Physical Activity Level in patients under 18 years of age
Time frame: Baseline visit, at 12 months, and at 24 months.
Measurement of Physical Activity Level in Adult Patients
Time frame: Baseline visit, at 12 months, and at 24 months.
Measurement of Treatment Adherence
Time frame: Baseline visit, at 12 months, and at 24 months.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Individual participant dataSharing planned: Undecided

Related trials for Hemophilia

RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
Active, not recruitingObservational study
A Study to Learn About the Study Medicine -Hympavzi in Congenital Hemophilia Patients Without Inhibitors in Japan.
Hemophilia A or B
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B

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.

Rubén Cuesta-Barriuso, PhD contact

0034 985103386

cuestaruben@uniovi.es

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hemophilia, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.

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 7 inclusion and 7 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rubén Cuesta-Barriuso, PhD (0034 985103386, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Ultrasonographically Detected Articular Damage in Elbows, Knees, and Ankles (time frame: Baseline visit, at 12 months, and at 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07420348.

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 20 Feb 2026.