Actively Recruiting
Effects of Emicizumab vs. Factor VIII Prophylaxis on Joint and Bone Health in Severe Hemophilia A
Led by Washington Institute for Coagulation · Updated on 2023-09-05
40
Participants Needed
4
Research Sites
382 weeks
Total Duration
On this page
Sponsors
W
Washington Institute for Coagulation
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators propose to study longitudinal joint and bone density changes in patients with severe Hemophilia A. Per current standard of care, most patients are on prophylactic FVIII replacement therapy intravenously several times weekly with a goal of keeping the trough \>1% FVIII. Recent phase 3 data suggest superior bleed protection with emicizumab prophylaxis every 1-2 weeks. It is the purpose of this study to longitudinally assess joint health and bone density over 3 years and to compare the effect of routine factor VIII prophylaxis with emicizumab prophylaxis.
CONDITIONS
Official Title
Effects of Emicizumab vs. Factor VIII Prophylaxis on Joint and Bone Health in Severe Hemophilia A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male gender
- Severe hemophilia A with factor VIII less than 1%
- Age 16 years or older
- Currently on prophylaxis with factor VIII or emicizumab and intending to continue the same treatment for the next 3 years
- Willing and able to provide written informed consent or assent
- Willing to undergo musculoskeletal ultrasound, DEXA bone density scan, and possibly blood sampling for biomarker research
- Willing to attend baseline and 3-year follow-up visits
- Willing to participate in phone surveys every 3 months to report bleeding and safety information
You will not qualify if you...
- Current factor VIII inhibitor level greater than 0.6 Bethesda units
- Unable to receive factor VIII replacement therapy
- Presence of any other bleeding disorder
- Presence of any rheumatologic disorder affecting joints
- Presence of any known neuromotor defect that impairs physical examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Orthopedic Hemophilia Treatment Center
Los Angeles, California, United States, 90007
Not Yet Recruiting
2
Hemophilia and Thrombosis Treatment Center, University of California, San Diego
San Diego, California, United States, 92092
Actively Recruiting
3
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
4
Washington Center for Bleeding Disorders at Washington Institute for Coagulation
Seattle, Washington, United States, 98101
Actively Recruiting
Research Team
R
Rebecca Kruse-Jarres, MD, MPH
CONTACT
C
Cassandra Bryan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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