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

Launched by WAYNE STATE UNIVERSITY · Aug 23, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how well a new medication called Emicizumab works compared to the standard treatment, Factor VIII, in preventing bleeding for boys with moderate to severe Hemophilia A while they play sports. Hemophilia A is a genetic condition that makes it hard for blood to clot, leading to frequent bleeding, especially during physical activities. The trial aims to find out which treatment helps keep these young athletes safer while they enjoy sports, which is important for their strength and social life.

To participate in this study, boys aged 6 to 19 years old who have moderate to severe Hemophilia A and are currently using either Emicizumab or Factor VIII are eligible. Participants must be actively playing sports that have a moderate to high risk of bleeding. They will need to keep daily logs about their activities and any bleeding incidents during the trial. This study is currently recruiting participants, and it offers a great opportunity to help improve care for young athletes with Hemophilia A.

Gender

MALE

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. Male participants with moderate to severe Hemophilia A ( FVIII activity \</= 5%) between 6 to 19 years of age 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 sports activities with moderate to high risk of bleeding as defined by the NHF- Playing it Safe guidelines (numerical rating \>/= 2).
• • 5. Participants must be compliant with completing all standard of care bleed and treatment logs
• • 6. Participant must be willing to keep daily activity 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. Participants on concomittent FVIII replacement and emicizumab for sports participation