Status:
RECRUITING
POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Hemophilia A
Factor VIII
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized control trial in which each patient will be randomly assigned to receive either extended half-life factor VIII based replacement therapy or non-FVIII based replacemen...
Detailed Description
This is a research study to find out if there is a difference in the way children with hemophilia A form a clot and also evaluate if they develop tiny bleeds within the joint and subsequently early jo...
Eligibility Criteria
Inclusion
- Subjects with moderate hemophilia A (baseline factor VIII activity 1-5%) or severe hemophilia A (baseline factor VIII activity \<1%) on prophylactic standard half-life FVIII infusions OR subjects with moderate or severe hemophilia A who have not started prophylactic treatment
- Less than 18 years of age
Exclusion
- Subjects with documented FVIII inhibitor
- Subjects with a history of ≥ 2 target joints
- Subjects with a history of synovectomy
- Currently using medications known to impact bone and mineral metabolism (e.g., bisphosphonates, corticosteroids, estrogen, testosterone, calcitonin, thyroid hormone therapy);
- Disease states known to affect bone integrity (e.g., primary hyperparathyroidism, Paget's disease, clinically significant liver disease)
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04690322
Start Date
April 15 2021
End Date
July 1 2027
Last Update
March 3 2025
Active Locations (1)
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1
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75235