ADVATE Post Authorization Safety Surveillance
- Conditions
- Hemophilia A
- Registration Number
- NCT00214734
- Lead Sponsor
- Baxalta now part of Shire
- 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 routine clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 108
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
PHOENIX CHILDRENS Hospital
🇺🇸Phoenix, Arizona, United States
Arkansas Childrens Hospital
🇺🇸Little Rock, Arkansas, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
LONG BEACH MEMORIAL MED Center
🇺🇸Long Beach, California, United States
Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
🇺🇸Los Angeles, California, United States
Valley Children'S Hospital
🇺🇸Madera, California, United States
Children'S Hospital of S.W. Florida
🇺🇸Fort Myers, Florida, United States
BIODORON
🇺🇸Hollywood, Florida, United States
Nemours Children'S Clinic
🇺🇸Jacksonville, Florida, United States
NEMOURS CHILDREN'S CLINIC- Orlando
🇺🇸Orlando, Florida, United States
Scroll for more (27 remaining)PHOENIX CHILDRENS Hospital🇺🇸Phoenix, Arizona, United States