Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690322
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2020-12-27
Brief Title:
POCUS Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
POCUS Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 replacement therapy which are both standard of care treatment for persons with Hemophilia A
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 joint changes when receiving extended half-life factor VIII based replacement therapy vs non-FVIII based replacement as part of their hemophilia treatment to prevent spontaneous joint bleeds
Both therapies are standard of care therapies for patients with hemophilia A The only experimentalresearch procedures as part of this study include the thrombin generation assay and ultrasound All other procedures are standard of care
Both therapies are standard of care therapies for patients with hemophilia A The only experimentalresearch procedures as part of this study include the thrombin generation assay and ultrasound All other procedures are standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None