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New drug may let kids with hemophilia play sports safer

NCT ID NCT05022459

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 1 time

Summary

This study looks at whether Emicizumab, a newer drug, prevents bleeding during sports better than standard Factor VIII in children with moderate to severe hemophilia A. About 72 kids aged 6 to 19 who already play sports and take one of these drugs will be followed. The goal is to see which drug leads to fewer bleeds during physical activity.

What this could mean

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

Active substance
Emicizumab and Factor VIII
What this could lead to
If Emicizumab works better, it could allow kids with hemophilia A to play sports with fewer bleeds and less frequent injections.
What could go wrong
This is a small, early-stage study (72 participants) comparing two existing drugs, so results may not apply to all patients. Bleeding risk remains.

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 72 people

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

Started

Aug 2023

Expected to finish

Mar 2029

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

This study will enroll patients who are already on Emicizumab or FVIII prophylaxis as per standard of care and who are already participating in sports activities with moderate to high risk of bleeding.

Ages

6 to 19 years

Sex

Anyone

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. Participant (if 18 years of age or older) or parent/LAR is willing and able to provide written informed consent; minor participant is willing and able to provide assent, if applicable based on site and local regulations 2. Males and females between 6 to ≤ 19 years of age at time of enrollment with moderate to severe Hemophilia A (FVIII activity ≤ 5%) without inhibitors are eligible for participation in this study 3. Participants must be on Emicizumab or standard FVIII prophylaxis per institutional/primary hematologist recommendations 4. Participants must be engaging in or registered to start participating in one or more sports activities with moderate to high risk of bleeding as defined by the NHF- Playing it Safe guidelines (numerical rating \>/= 2). 5. Participant must be willing to keep activity, bleed, and treatment logs for the duration of the study Exclusion Criteria: 1. Participant/parent/LAR unwilling to provide informed consent/assent 2. Unwilling to log or document bleeds and treatment information as per study guidelines 3. Participants with any other bleeding disorders will be excluded 4. Patients who are pregnant, planning to become pregnant, or breastfeeding should not be enrolled in the study 5. Participants on concomittent FVIII replacement and emicizumab for sports participation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    10 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202, United States

    Contact Email: •••••@•••••

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Michigan

    RECRUITING

    Detroit, Michigan, 48201, United States

    Contact Email: •••••@•••••

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • Indiana Hemophilia & Thrombosis Center

    RECRUITING

    Indianapolis, Indiana, 46260, United States

    Contact Email: •••••@•••••

  • Johns Hopkins All Children's Hospital

    RECRUITING

    St. Petersburg, Florida, 33701, United States

    Contact Email: •••••@•••••

  • Oklahoma Center for Bleeding and Clotting Disorders

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

    Contact Email: •••••@•••••

  • Rady Children's Hospital

    RECRUITING

    San Diego, California, 92123, United States

    Contact Email: •••••@•••••

  • Rush University Children's Hospital

    RECRUITING

    Chicago, Illinois, 60612, United States

    Contact Email: •••••@•••••

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

    Contact Email: •••••@•••••

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