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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Washington Institute for Coagulation
Study ID
NCT04131036
Status
Recruiting
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Conditions

  • Hemophilia A

Eligibility Criteria

Sex
MALE
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • assessment of joint health and bone density — OTHER
    We propose to study longitudinal joint and bone density changes in patients with severe Hemophilia A.

Study Details

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.

Key Dates

Start date
Apr 4, 2019
Status verified
Aug 2023
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Arm A
    Male patients with severe Hemophilia A who use prophylaxis with IV factor VIII concentrate with intended trough \>1%.
  • Arm: Arm B
    Male patients with severe Hemophilia A who use prophylaxis with SQ emicizumab.

Primary Outcome Measure

joint health comparison [ Time Frame: 3 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Orthopedic Hemophilia Treatment CenterLos AngelesCalifornia90007-
Hemophilia and Thrombosis Treatment Center, University of California, San DiegoSan DiegoCalifornia92092
Isabel Chang
[email protected]
Annette Von Drygalski, MD, PharmD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Jeffrey Kallberg, DPT
[email protected]
Washington Center for Bleeding Disorders at Washington Institute for CoagulationSeattleWashington98101
Rebecca Kruse-Jarres, MD, MPH
[email protected]
206-614-1200
Rebecca Kruse-Jarres, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Orthopedic Hemophilia Treatment Center· Los Angeles, CAHemophilia and Thrombosis Treatment Center, University of California, San Diego· San Diego, CAThe University of Texas Health Science Center at San Antonio· San Antonio, TXWashington Center for Bleeding Disorders at Washington Institute for Coagulation· Seattle, WA

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