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NCT05022459 · ClinicalTrials.gov registry record
Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis
A clinical trial of Hemophilia A, sponsored by Wayne State University.
- Recruiting
- Registry status
- 72
- Enrollment target
- 9
- Study locations
NCT05022459 is a study of Hemophilia A that is actively recruiting participants, run by Wayne State University. The registered enrollment target is 72 participants, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (20% lower). The trial reports 9 study locations across 8 states.
The verdict
NCT05022459, a study of Hemophilia A, is actively recruiting participants, sponsored by Wayne State University.
- RECRUITING
- Registry status
- 72 participants
- Enrollment target
- 9
- Study locations
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 Studied
Interventions
- DRUG Emicizumab
- DRUG FVIII
Study Locations (9)
California
- Stanford University - Palo Alto
- Rady Children's Hospital - San Diego
Arkansas
- Arkansas Children's Hospital - Little Rock
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Indiana
- Indiana Hemophilia & Thrombosis Center - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
Michigan
- Children's Hospital of Michigan - Detroit
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Oklahoma
- Oklahoma Center for Bleeding and Clotting Disorders - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-08-16 |
| Est. Completion | 2029-03 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05022459
The ClinicalTrials.gov registry entry for NCT05022459 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (20% lower). The listed sponsor is Wayne State University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 2 interventions - of which Emicizumab is the first listed.
NCT05022459 reports 9 study locations spanning 8 distinct geographic areas - top geographies include California, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT05022459 about?
NCT05022459 is a clinical study titled "Prevention of Bleeding in Patients With Moderate and Severe Hemophilia A Playing Sports: A Comparison Between Factor VIII and Emicizumab Prophylaxis". 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 d...
What is the current status of trial NCT05022459?
This trial is currently recruiting. The enrollment target is 72 participants. The study started on 2023-08-16. Estimated completion is 2029-03.
What conditions does trial NCT05022459 study?
This clinical trial studies the following conditions: Hemophilia A.
What interventions are being tested in trial NCT05022459?
The interventions under investigation include: Emicizumab (DRUG), FVIII (DRUG).
Who is sponsoring clinical trial NCT05022459?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05022459 being conducted?
This trial has 9 study locations across Arkansas, California, Florida, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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