RecruitingNCT05022459

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

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


Sponsor

Wayne State University

Enrollment

72 participants

Start Date

Aug 16, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 6 YearsMax Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Emicizumab and a drug called FVIII for people with hemophilia a. The study is currently recruiting participants at 9 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmicizumab

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

DRUGFVIII

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


Locations(9)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Stanford University

Palo Alto, California, United States

Rady Children's Hospital

San Diego, California, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Indiana Hemophilia & Thrombosis Center

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Oklahoma Center for Bleeding and Clotting Disorders

Oklahoma City, Oklahoma, United States

View Full Details on ClinicalTrials.gov

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NCT05022459


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