Effects of Emicizumab vs. Factor VIII Prophylaxis on Joint and Bone Health in Severe Hemophilia A

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 16
Healthy Volunteers: f
View:

• Male gender

• Severe hemophilia A (factor VIII \< 1%)

• Age ≥ 16 year

• Either on prophylaxis with factor VIII or emicizumab with the intention to stay on the current regimen for the next 3 years

• Willing and able to give written informed consent/assent

• Willing to undergo MSKUS, DEXA scan +/- collection of blood sampling for repository biomarkers

• Willing to come in for baseline and 3 yearly visits

• Willing to answer phone survey for bleeding and safety every 3 months

Locations
United States
California
Orthopedic Hemophilia Treatment Center
NOT_YET_RECRUITING
Los Angeles
Hemophilia and Thrombosis Treatment Center, University of California, San Diego
RECRUITING
San Diego
Texas
The University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Washington
Washington Center for Bleeding Disorders at Washington Institute for Coagulation
RECRUITING
Seattle
Contact Information
Primary
Rebecca Kruse-Jarres, MD, MPH
RKJ@WACBD.org
206-614-1200
Backup
Cassandra Bryan
cassandra.bryan@wacbd.org
206-681-9072
Time Frame
Start Date: 2019-04-04
Estimated Completion Date: 2026-08
Participants
Target number of participants: 40
Treatments
Arm A
Male patients with severe Hemophilia A who use prophylaxis with IV factor VIII concentrate with intended trough \>1%.
Arm B
Male patients with severe Hemophilia A who use prophylaxis with SQ emicizumab.
Related Therapeutic Areas
Sponsors
Collaborators: Genentech, Inc.
Leads: Washington Institute for Coagulation

This content was sourced from clinicaltrials.gov