Status:
COMPLETED
ADVATE Post Authorization Safety Surveillance
Lead Sponsor:
Baxalta now part of Shire
Collaborating Sponsors:
Baxter BioScience
Conditions:
Hemophilia A
Eligibility:
MALE
Brief Summary
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in rou...
Eligibility Criteria
Inclusion
- Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
- Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)
- Subject has been prescribed ADVATE by their treating physician
- Subject may be of any age
- Subject or parent/legally authorized representative has provided written informed consent
Exclusion
- None
Key Trial Info
Start Date :
October 14 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 2 2007
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00214734
Start Date
October 14 2004
End Date
March 2 2007
Last Update
March 17 2021
Active Locations (37)
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1
PHOENIX CHILDRENS Hospital
Phoenix, Arizona, United States, 85016
2
Arkansas Childrens Hospital
Little Rock, Arkansas, United States, 72202
3
City of Hope National Medical Center
Duarte, California, United States, 91010
4
LONG BEACH MEMORIAL MED Center
Long Beach, California, United States, 90806