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Hemophilia a bone health under the microscope: which treatment wins?

NCT ID NCT07582276

Knowledge-focused Sponsor: Arkansas Children's Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will follow 50 men with severe hemophilia A for five years to compare bone density between those taking emicizumab and those taking efanesoctocog alfa. Researchers will also measure bone remodeling markers and joint health. The goal is to see if one treatment is linked to better bone outcomes, which could help doctors choose the best therapy for long-term bone health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
emicizumab or efanesoctocog alfa
What this could lead to
If successful, this study could show which hemophilia A treatment better protects bone health, potentially guiding future therapy choices.
What could go wrong
This is an observational study, not a treatment trial. It only measures bone changes, so it won't directly improve health. Results may take years and might not lead to clear conclusions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients that are seen at dedicated Hemophilia treatment Centers

Ages

30 to 50 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The participant or legally authorized representative is willing and able to provide written informed consent. 2. Diagnosis of severe hemophilia A (factor VIII activity \< 1%). 3. Male sex. 4. Age between 30 and 50 years (inclusive). 5. BMI between 18.5 and 40 kg/m2 6. The participant must have been on prophylaxis with Efanesoctocog alfa or Emicizumab for at least 3 months prior to enrollment and intend to remain on the current regimen for the next 5 years. 7. Willingness to undergo all research procedures, including DEXA scans and the collection of blood samples. 8. Willingness to complete all standard-of-care bleeding and treatment logs. Exclusion Criteria: 1. Unwillingness of the participant, parent, or legally authorized representative to provide informed consent. 2. Diagnosis of a bleeding disorder other than or in addition to severe hemophilia A. 3. Active Factor VIII inhibitors at the time of enrollment 4. History of a disease known to influence bone metabolism unrelated to a bleeding disorder. (Examples: Paget's disease, osteogenesis imperfecta, Ehlers Danlos syndrome, Hyperparathyroidism) 5. Past or present treatment with any anti-osteoporotic medication, excluding oral vitamin D or oral calcium supplements. 6. Documented HIV infection or HCV infection (whether in progress or cured) at the cirrhotic stage. 7. Presence of a non-removable metal device that would interfere with research procedures. 8. Inability to tolerate a DEXA scan due to limited range of motion or body habitus. 9. History of bone fractures or surgical repair within 8 weeks prior to enrollment. 10. Participants with weight \>300 pounds, due to limitations of DEXA scanner

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Conditions

The condition(s) this trial relates to.

hemophilia A severe hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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