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Keep this study
Lead
Oregon Health and Science University
With
Baxter Healthcare Corporation
This is a pilot study to determine the impact of factor replacement on bone biomarkers in up to 20 hemophilia A subjects. Subjects will be recruited over 1 year for the 5-day protocol.
Following a 72-hour washout period, factor levels and bone biomarkers will be followed before and after 50 units/kg replacement on Day 1 and 20 units/kg replacement on Day 3. Each subject can serve as their Figure 4. Fracture rates in PwH compared to historic controls.
Age
16–85
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%.
2. Age \> 16 years old
3. Currently using ADVATE as FVIII replacement therapy
You may not be if
1. Subject or guardian is unwilling or unable to give written informed consent and/or assent
2. Joint or muscle bleeding within 2 weeks of Study Day 1
3. Presence of a current factor inhibitor (\>0.6 BU/mL via Nijmegan-modified Bethesda assay)
