At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 16 enrolled
Drug / intervention
Advatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Biomarkers of Bone Metabolism in Hemophilia A
In Brief
A Phase 3 clinical trial evaluating Advate for Hemophilia and Bone Disease. Completed, enrolled 16 participants across 1 site.
Detailed 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 hemophilia population. This study demonstrates that PwH have an increased risk of fracture compared to the general population and that the issue of bone health will increase in importance as the PwH population ages.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia, Bone Disease
CountriesUnited States
CollaboratorsBaxter Healthcare Corporation
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartDec 2014
First PostedDec 2014
Primary CompletionApr 2018
TodayJul 2026
First PostedDec 3, 2014
Enrollment StartDec 1, 2014
Primary CompletionApr 16, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.6 years ago
Interventions
Advatedrug
Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study.