NCT05022459 Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis
| NCT ID | NCT05022459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wayne State University |
| Condition | Hemophilia A |
| Study Type | OBSERVATIONAL |
| Enrollment | 72 participants |
| Start Date | 2023-08-16 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 72 participants in total. It began in 2023-08-16 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The exact factor level that is needed to safely participate in sports and minimize bleeding risk is not yet known. Based on clinical practice, infusion of FVIII to near the lower limit of normal right before participation in sports generally works to prevent bleeding. The study is looking at how well the newly approved medication Emicizumab works compared to Factor VIII to prevent bleeding in patients with Hemophilia A who play sports. The study will enroll children and adolescents who are already on Emicizumab or Factor VIII who are currently playing sports.
Eligibility Criteria
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
Contact & Investigator
Meera Chitlur, MD
PRINCIPAL INVESTIGATOR
Wayne State University
Frequently Asked Questions
Who can join the NCT05022459 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 19 Years, studying Hemophilia A. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05022459 currently recruiting?
Yes, NCT05022459 is actively recruiting participants. Contact the research team at stepstudy@wayne.edu for enrollment information.
Where is the NCT05022459 trial being conducted?
This trial is being conducted at Little Rock, United States, Palo Alto, United States, San Diego, United States, St. Petersburg, United States and 6 additional locations.
Who is sponsoring the NCT05022459 clinical trial?
NCT05022459 is sponsored by Wayne State University. The principal investigator is Meera Chitlur, MD at Wayne State University. The trial plans to enroll 72 participants.