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Observational Study on Joint and Bone Health in Severe Hemophilia A

This observational study is looking at how different treatments for severe hemophilia A (a bleeding disorder) affect your joints and bones over three years. Researchers want to compare patients who are taking emicizumab (a medicine given every 1-2 weeks) with those on factor VIII prophylaxis (a medicine given several times a week). They will use special imaging like musculoskeletal ultrasound (MSKUS) to check joint health and DEXA scans for bone density. You can join if you are a male, at least 16 years old, have severe hemophilia A, and are already on either emicizumab or factor VIII prophylaxis and plan to stay on it for three years. The main goal is to see how joint health changes between these two treatment groups.

Study design
This is an observational study, meaning participants will be assigned to one of two groups based on their current treatment. It aims to enroll 40 male participants.
What's involved
You would undergo MSKUS and DEXA scans at the beginning and after three years, and potentially provide blood samples. You would also need to come in for visits.
Compensation
Not stated in the trial record.
Follow-up
Your joint health will be compared at the start of the study and again after three years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04131036

Effects of Emicizumab vs. Factor VIII Prophylaxis on Joint and Bone Health in Severe Hemophilia A

Recruiting
Not specifiedAges 16+Observational
Washington Institute for Coagulation
~40 participants
Updated 2023-09-05 on ClinicalTrials.gov
What's tested:assessment of joint health and bone density

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
joint health comparison
Measured over 3 years

Conditions

Hemophilia A

Explore related trials

Hemophilia ACoagulation Factor VIII

Where it's being run

4 sites across 3 states
California2
Texas1
Washington1

Study leadership

  • Rebecca Kruse-Jarres, MD, MPH · PRINCIPAL_INVESTIGATOR · Washington Institute for Coagulation

Who to contact

Rebecca Kruse-Jarres, MD, MPH
[email protected]
206-614-1200
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Male gender
Severe hemophilia A (factor VIII \< 1%)
Age ≥ 16 year
Either on prophylaxis with factor VIII or emicizumab with the intention to stay on the current regimen for the next 3 years
Willing and able to give written informed consent/assent
Willing to undergo MSKUS, DEXA scan +/- collection of blood sampling for repository biomarkers
Willing to come in for baseline and 3 yearly visits
Willing to answer phone survey for bleeding and safety every 3 months

Exclusion

Current FVIII inhibitor of \> 0.6 BU
Unable to take FVIII replacement
Other known bleeding disorder
Other rheumatologic disorder affecting joints
Other known neuromotor defect (making physical exam difficult)

What this trial measures

  • joint health comparison3 years

    Joint health changes over 3 years compared between group A (factor prophylaxis) vs. group B (emicizumab prophylaxis) as assessed by MSKUS at baseline and after 3 years.