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Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis

Recruitingn/aAges 6 Years - 19 YearsAllWayne State University
NCT05022459 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Hemophilia A (HA) is a genetic bleeding disorder resulting from a deficiency or absence of factor VIII (FVIII), which is necessary in the clotting process. This disorder occurs mostly in males and in severe cases causes frequent bleeding episodes in joints and muscles which can lead to progressive damage that affects mobility and quality of life. Prophylactic FVIII administered intravenously every other day has been the standard of care treatment for HA for the past few decades. Sports and physical activity are generally encouraged in patients with hemophilia on appropriate prophylactic treatment to increase strength, prevent or decrease obesity, accrue and maintain bone density and encourage normal socialization. To ensure safety with participation in sports in persons with hemophilia A (PWHA), timing of FVIII administration is often adjusted to maximize FVIII at the time of sports. Th

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📋 Eligibility rules (as published)
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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What it tests

  • Emicizumab
  • FVIII
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Where

10 sites
Arkansas Children's Hospital
Little Rock, United States
Stanford University
Palo Alto, United States
Rady Children's Hospital
San Diego, United States
Johns Hopkins All Children's Hospital
St. Petersburg, United States
Rush University Children's Hospital
Chicago, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, United States
Boston Children's Hospital
Boston, United States
Children's Hospital of Michigan
Detroit, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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