Status:
COMPLETED
Prospective Biomarkers of Bone Metabolism in Hemophilia A
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Hemophilia
Bone Disease
Eligibility:
MALE
16-85 years
Phase:
PHASE3
Brief Summary
One of the major shortcomings in studying bone disease in hemophilia is the lack of fracture outcome data demonstrating the clinical significance of decreased BMD and altered bone biomarkers in the he...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Males with a diagnosis of hemophilia A with a historic baseline FVIII level ≤ 2%.
- Age \> 16 years old
- Currently using ADVATE as FVIII replacement therapy
Exclusion
- Subject or guardian is unwilling or unable to give written informed consent and/or assent
- Joint or muscle bleeding within 2 weeks of Study Day 1
- Presence of a current factor inhibitor (\>0.6 BU/mL via Nijmegan-modified Bethesda assay)
- Known collagen vascular bone disease.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02306694
Start Date
December 1 2014
End Date
April 16 2018
Last Update
April 1 2020
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239