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

NCT04131036 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-09-05

No results posted yet for this study

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.

Conditions

Interventions

OTHER

assessment of joint health and bone density

We propose to study longitudinal joint and bone density changes in patients with severe Hemophilia A.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Washington Institute for Coagulation

    lead OTHER

Principal Investigators

  • Rebecca Kruse-Jarres, MD, MPH · Washington Institute for Coagulation

Eligibility

Min Age
16 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04131036 on ClinicalTrials.gov