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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

NCT05022459 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2026-01-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Emicizumab

Patients in this group will be on standard of care Emicizumab prophylaxis for Hemophilia A

DRUG

FVIII

Patients in this group will be on standard of care FVIII prophylaxis for Hemophilia A

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Wayne State University

    lead OTHER

Principal Investigators

  • Meera Chitlur, MD · Wayne State University

Eligibility

Min Age
6 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-16
Primary Completion
2029-01-31
Completion
2029-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022459 on ClinicalTrials.gov